Filter Applied » clinical research

New Research Suggests No Link Between Ovarian Cancer and Fertility Drugs

Since the 1990s, researchers have published conflicting results about the connection between cancer risk and fertility drugs. As a result, there has been a lingering concern among women that using fertility drugs may increase their risk for later developing hormone receptor positive cancers. Hormone receptor positive tumors consist of cells that express receptors for certain hormones such as estrogen or progesterone, but are most commonly known as estrogen receptor tumors. These types of tumors depend on the presence of estrogen in order to grow and spread throughout the body, making the risk for gynecologic cancers cause for concern in some women undergoing IVF treatment.

Fertility drugs have come under scrutiny because they stimulate hyper-ovulation, meaning they cause a woman’s body to produce more eggs. They have been linked to certain gynecologic cancers, such as breast and ovarian cancer. One reason research published in the 1990s may have suggested a link between fertility drugs and cancer risk, is due to the drugs that were being prescribed 20 years ago. Researchers have also blamed the mixed nature of the findings on the studies’ relatively short length, or on including women who have not given birth as they are known to have an increased risk of some cancers.

New research, however, suggests that using fertility drugs does not have an impact on your risk for developing ovarian cancer down the line. Lead author of the study and clinical fellow in the Division of Reproductive Endocrinology at the Mayo Clinic in Rochester, Minnesota, Dr. Albert Asante and his colleagues gathered medical information on 1900 women from an ongoing ovarian cancer study at the Mayo Clinic. The researchers compared 1,028 women with ovarian cancer to 872 women of similar age who did not have cancer. As reported in Fertility and Sterility, approximately 24 percent of the women who did not have ovarian cancer reported having used fertility drugs, while roughly 17 percent of women who had ovarian cancer had used fertility drugs.

The researchers took into account factors that can influence the risk for ovarian cancer, such as age and use of the birth control pill, and found no difference in cancer rates between the groups. Dr. Asante looked specifically at whether women in the study who reported being infertile- whether or not they had taken fertility drugs – had a greater chance of developing ovarian cancer, and found no added risk. He said one explanation for the result is that most of the women in his study had infertility issues, but eventually became pregnant. According to Dr. Albert Asante, “One important message [from this study] is women who need to use fertility drugs to get pregnant should not worry about using these fertility drugs.”

To read more about this new study, click HERE for the full text. To learn more about your reproductive options when faced with a cancer diagnosis, please visit www.SaveMyFertility.org.

 

Introducing Cancer Survivorship Training for Healthcare Professionals

There are an estimated 13 million cancer survivors living in the US today, with projected growth to 18 million by 2020. As a result, many healthcare groups and cancer centers are not equipped to address their growing survivor populations. Stemming from this need for quality after care, researchers from the University of Kansas (KU) developed Cancer Survivorship Training (CST), an eLearning solutions provider, to help improve the lives and well-being of cancer survivors by educating and training the healthcare professionals that care for them.

CST online and community courses are designed to increase education, knowledge and skills about survivorship care through theory-based and practical continuing education online curriculum and mobile based learning. The training also provides essential tools for developing and sustaining formal survivorship programs, including oncofertility resources. The Oncofertility Consortium partnered with researchers at KU to help develop CST’s oncofertility course, providing fertility preservation education and options. As studies have shown, fertility is an important factor in many young cancer survivors quality of life following treatment, thus educating patients about their reproductive options is a critical component of comprehensive cancer and survivorship care.

Lead developer of CST, Jennifer Klemp, PhD, MPH, is an Assistant Professor in the Department of Internal Medicine at the KU. Dr. Klemp has a strong interest in patients’ quality of life issues following cancer treatment and is the Director of Cancer Survivorship at KU Cancer Center. She designed CST to deliver continuing education to health care providers actively involved in the care of cancer survivors, including; physicians, oncology nurses, mid-level practitioners, allied health professionals, and practice administrators.

CST emphasizes the importance of post-treatment survivorship care as well as the opportunity for education and prevention of late and long-term effects, including infertility, from the time of diagnosis.  The multi-disciplinary approach provides the healthcare provider with information to care for the needs of cancer survivors from the time of diagnosis and develop skills focusing on essential elements to the delivery of survivorship. To learn more about Cancer Survivorship Training, please visit www.cancersurvivorshiptraining.com or click here.

Science, Policy, and the Dickey-Wicker Amendment (Part 1)

By Cathryn Smeyers

On Thursday, February 21st, Gregory Dolin, MD, JD, Associate Professor of Law and Co-Director of the Center of Medicine & Law at the University of Baltimore School of Law, delivered our Virtual Grand Rounds.  His talk, entitled “Speaking of Science: Legal Updates in Oncofertility,” focused on the knowledge gap that often exists between the scientific community and government policy makers and the serious ramifications this can have on scientific progress.  To illustrate this point, Dr. Dolin focused specifically on the Dickey-Wicker Amendment.

The Dickey-Wicker Amendment (DWA), passed by Congress in 2006, bans federal funding for research using embryos and parthenotes (a group of cells derived from an egg that begins dividing without fertilization from sperm). Parthenotes contain genetic material from only the maternal source, whereas embryos are created through fertilization and contain genetic material from both female and male. In higher-order organisms (including humans), a parthenote cannot result in a viable full-term offspring.  Consequently, when the DWA expanded the ban on federal funding to include parthenotes, in addition to embryos, it put an end to scientific research being done on cells that have no potential to result in human life.

Scientific research involving parthenotes is key to oncofertility because it provides invaluable insight into the early stages of pregnancy and embryonic development (which can lead to improvements in Assisted Reproductive Technologies), miscarriages, and tumors. Objections to the use of embryos in research stem from the claim that embryos constitute (or have the potential to become) human life.  Parthenotes, however, do not experience fertilization and do not have the potential to become human life.  Why, then, with regard to federal funding for scientific research, should parthenotes be placed in the same category as embryos?

This is the very question that Dr. Dolin tackled in last week, and his answer was alarming.  According to Dr. Dolin, Congress often legislates without understanding the full scope of its enactments.  He argues that the problem is particularly acute in the areas of science, because Congressmen do not understand science.  Currently, out of the 535 members of Congress, we have one physicist, 22 people with medical training, one chemist, one microbiologist and six engineers.  Consequently, when it comes to complex scientific issues, such as the distinction between an embryo and a parthenote, Congress can pass legislation based on incorrect or incomplete information.

Keep reading tomorrow for Part 2…

New Study on Tamoxifen Suggests Longer Treatment for Some Women

There are more than 400,000 female cancer survivors below age 40 in the United States today, due primarily to the relatively large number of young women who are diagnosed with, and beat, breast cancer. Approximately 70% of breast cancers are identified as estrogen receptor-positive (ER-positive), meaning they express estrogen receptors and grow when exposed to the hormone estrogen. Tamoxifen, an estrogen receptor antagonist (meaning it prevents activation) is used to reduce cancer recurrence and mortality in premenopausal women with ER-positive cancers. Current general practice encourages women to take Tamoxifen for at least 5 years after an initial cancer diagnosis to reduce the risk for relapse but a recent study indicates that longer Tamoxifen treatment may be even better.

The recent study published in The Lancet examined the relapse and mortality rates of women who took Tamoxifen for 10 years after initial cancer diagnosis, rather than the established 5. The authors identified that 15 years after diagnosis, cancer recurrence rates were 3.03% in the 5-year tamoxifen-treated women, compared to 2.54% in the 10-year treated women. Similarly, death in these survivors occurred in 2.29% of the 5-year treated women versus 1.64% in the women who were on tamoxifen for 10 years. These results indicate that some women may want to extend tamoxifen therapy to get maximal benefit from the drug.

It is important to note that, in the study, the majority of benefit from tamoxifen did occur in the first five years of treatment so some women may still choose to take the drug for 5 years. Multiple factors, including side effects that negatively impact quality of life, may cause women to choose the shorter treatment schedule. These include endometrial cancer, venous thromboembolic events, cataracts, hot flashes, and other symptoms associated with menopause. Currently, up to 50% of patients discontinue tamoxifen prior to reaching the 5-year mark and women under age 40 are at highest risk to discontinue therapy.

In addition to side effects, considerations about fertility may affect tamoxifen adherence rates in younger women. Tamoxifen is a teratogen, meaning it can cause prenatal malformations. Thus, young cancer survivors who are interested in pregnancy may be hesitant to take the extra years of tamoxifen examined in the study. For example, a 30 year-old woman diagnosed with cancer may be able to wait until age 35 to have children but not able to wait until age 40, when her reproductive chances have declined significantly. Given the new study and individual considerations for young women, each ER-positive breast cancer survivor should discuss the pros and cons of extending tamoxifen therapy in her specific case, with her doctor. If you have a question about your reproductive options after a cancer diagnosis, contact the Oncofertility Consortium‘s FERTline at 866-708-FERT (3378).

 

Pregnancy & Cancer Registry

Finding out your pregnant can be one of the happiest times in your life. Couple that with a cancer diagnosis and suddenly you’re not only concerned about your health, but that of the new life you are busy growing. Cancer during pregnancy is rare, occurring in approximately one out of every 1,000 pregnancies, and breast cancer is the most common cancer diagnosed during pregnancy. Currently, little research is available to guide women and doctors during this uncertain time.

When making treatment decisions for cancer during pregnancy, the doctor considers the best treatment options for the mother and the possible risks to the baby. The type of treatment given depends on many factors including, gestational age of the baby; the type, location, size, and stage of the cancer; and the decisions of the expectant mother and family. Some cancer treatments can harm the fetus, especially during the first trimester; therefore, treatment may be delayed until the second or third trimesters. When cancer is diagnosed later in pregnancy, doctors may wait to start treatment until after the baby is born, or they may consider inducing labor early.

Unfortunately, the current medical literature cannot answer all the relevant questions for a woman facing a cancer diagnosis during pregnancy. Few oncologists or obstetricians treat more than 2 or 3 patients in this situation in an entire career. The only way to gain the necessary knowledge about cancer found and treated during pregnancy is to gather together experience from various hospitals into one single database. To the benefit of oncofertility, Dr. Elyce Cardonick, a Maternal Fetal Medicine Physician at Cooper University Health Care in New Jersey, is doing just that.

Dr. Cardonick has created a health registry, which collects information about the diagnosis, and treatment of cancer in pregnant women. According to Dr. Cardonick, the information collected is strictly confidential and will help study the effects of a newly diagnosed cancer and its treatment on a concurrent pregnancy. Additionally, the interaction of a pregnancy on the natural history of certain types of cancer will also be studied. Some women have even received chemotherapy during pregnancy and delivered healthy infants. Dr. Cardonick is also interested in including pregnant women with a history of cancer in a separate database. In both studies, the health of the women and their children are followed yearly in cooperation with the patient’s oncologist, pediatrician and obstetrician.

For more information about the pregnancy and cancer registry or to become a participant, please call (877) 635-4499 or visit www.cancerandpregnancy.com. To learn more about the role of OB/GYN in comprehensive cancer care, please read this previous blog.

Educating an Oncofertility Specialist

Oncofertility is an interdisciplinary field at the intersection of oncology and reproductive science. While those two fields make up the breadth of this discipline, it only touches the surface of what future clinicians need in their academic repertoire to successfully navigate this field.  In “Preparing an Interdisciplinary Workforce in Oncofertility: A Suggested Educational and Research Training Program,” in Oncofertility Medical Practice: Clinical Issues and Implementation, author Christos Coutifaris, MD, PhD, argues that the education and training of oncofertility professionals should involve, “oncology, pediatrics, reproductive science and medicine, biomechanics, material science, mathematics, social science, bioethics, religion, policy research, reproductive health law, and cognitive and learning science.”

Going forward, the National Institute of Health (NIH) has an ambitious agenda requiring multifaceted scientists and clinicians properly trained in both research and medicine. Ideally, physicians would be trained not only clinically, but they would also be prepared for investigative careers. According to Dr. Coutifaris, “the ultimate goal is to prepare reproductive endocrinologists, pediatric and adult oncologists, and surgeons, for investigative careers that focus on the reproductive, endocrine, and fertility needs of cancer patients and survivors.” By doing so, oncofertility specialists would be at the forefront of translational medicine, further benefiting the reproductive outcomes of cancer patients.

Dr. Coutifaris presents a well-laid training program for future oncofertility specialists. This includes establishing an executive steering committee responsible for the overall direction of the program, an advisory board to aid and shape the content of the program, an expert and diverse group of faculty members to mentor trainees, and research training, specifically focusing on the human oocyte. There should also be a comprehensive program evaluation in place to monitor the success of the program.

Having a dedicated oncofertility program in place to ensure that fertility options for young cancer patients is factored into their cancer care, is imperative.  Training and educating the next generation of oncofertility specialists will lay the foundation for improved cancer care and reproductive outcomes. Read, “Preparing an Interdisciplinary Workforce in Oncofertility: A Suggested Educational and Research Training Program,” to learn more about educating the next generation of oncofertility specialists. Participate in our new series of CME-accredited Virtual Grand Rounds to increase communication and education among healthcare providers.

 

Is the HPV Vaccine Providing Community Immunity?

A new study suggests that the HPV vaccine may be protecting immunized teens and young adults from Human Papillomavirus (HPV) infections as well as those who were not vaccinated via a phenomenon known as community immunity (or herd immunity).

Promising data showing a significant reduction in certain HPV strains for both vaccinated and unvaccinated women recruited from two community clinics in Ohio four years ago comes as a pleasant surprise to researchers.   The study lead by Dr. Jessica Kahn at the Cincinnati Children’s Hospital will appear in the August 2012 journal issue of Pediatrics.   The study shows a near 70% reduction in HPV infection for those who received the vaccine and 50% in unvaccinated individuals after four years.

The theories behind community or “herd immunity” are based on the idea that once a significant proportion of a population is vaccinated, the protective benefits of the vaccine are extended throughout that community, even to those who have not or can not be vaccinated.  Two examples where community immunity thresholds have been achieved through vaccine in modern medical history are against polio and smallpox.

The Human Papillomavirus causes virtually all cases of cervical cancer and genital warts.  According to the Centers for Disease Control (CDC), more than 20 million people in the US are infected with HPV, with 6.2 million new cases reported each year.  HPV remains the most common sexually transmitted infection with more than 30 known strains.  There are currently no treatments for HPV infection.

The HPV vaccination program was first introduced in 2006 with the Gardasil quadrivalent vaccine, that protects against four HPV strains (HPV-6, -11, -16, and -18).  The strains HPV-16 and -18 have been shown to significantly increase the risk of cervical cancer.  Currently, there are two vaccines approved for use by the Food and Drug Administration (FDA), Gardasil by Merck and Cervarix by GlaxoSmithKline.  Cervarix also targets the HPV-16 and -18 strains.

Participants in the study lead by Dr. Kahn received the Gardasil vaccine.  More than 70% of all cervical cancer cases and 90% of genital warts cases have been linked to the one of the HPV-6, -11, -16, and -18 strains.

Although the results of the Cincinnati Children’s Hospital study offer great promise, future studies are needed to confirm the observed protective effects in a larger and more diverse population.   Dr. Kahn’s study followed a small group of approximately 400 teens and young adults in two areas of Ohio who consisted of mostly African American and non-Hispanic descent.

The proportion of a population needed to achieve the community benefit of a vaccine depends on the severity of the disease, the ability of the vaccine to protect against the virus, and the mode of transmission.  No vaccine can offer complete protection.  Cervical screening or pap smears remain the first defense for early detection and prevention.  It takes several years for community immunity to develop, and the HPV vaccine is only 6 years old.  It is nonetheless exciting to see an effect of the vaccine so soon.

The National Cancer Institute Focuses on Oncofertility

About 70,000 adolescents and young adults (ages 15-39) are diagnosed with cancer each year in the United States. During cancer treatment, adolescents and young adults (AYA) may focus all of their energy on getting through treatment. Some may not have spent much time talking or thinking about life after cancer treatment, and the impact their cancer treatment may have on their survivorship. Life after treatment often presents a new set of challenges and fertility may be one of the challenges that survivors face once treatment ends and family planning begins.

The importance of fertility options for AYA’s diagnosed with cancer has not been lost on the National Cancer Institute (NCI), which is one of 11 agencies that compose the Department of Health and Human Services (HHS). The NCI, established under the National Cancer Institute Act of 1937, is the Federal Government’s principal agency for cancer research and training. Recently, the NCI featured oncofertility in the NCI Cancer Bulletin, a distinguished news source for the latest in cancer research, in an article entitled, “So Others May Benefit: Young Cancer Patients and Survivors Take Part in Oncofertility Research.”

Understanding fertility outcomes for the AYA cancer population is imperative to improving the cancer treatment process and ensuring that fertility preservation discussions become standard procedure in comprehensive cancer care. Fertility preservation is of special concern for AYA cancer patients, a group that historically has been underrepresented in clinical research studies. “So Others May Benefit: Young Cancer Patients and Survivors Take Part in Oncofertility Research,” explores the unique approach that the Oncofertility Consortium used to get their attention and increase AYA participation in clinical studies: social media.

The success of this new outreach effort can be seen in the Consortium’s Fertility Information Research Study (FIRST). FIRST is a fertility information research study for young women who are facing or have faced cancer treatment. Researchers want to learn more about how cancers and treatments affect the reproductive health of young survivors, and whether or not cancer survivors wish to have children in the future or not.

When FIRST was initially launched, researchers had some difficulty recruiting study participants, due to the challenges AYA’s pose to researchers (in other words – they can be hard to track down). After some initial brainstorming, they decided to utilize their relationships with some of the leading AYA advocacy groups such as Stupid Cancer and Imerman Angels to reach the AYA population. After the first posting about the study on Twitter and Facebook, researchers received 15 calls from cancer patients willing to participate. Today, FIRST has 200 participants and counting, many of them learning about the study via social media.

To learn more about how the Oncofertility Consortium is changing the face of comprehensive cancer care through social media, read “So Others May Benefit: Young Cancer Patients and Survivors Take Part in Oncofertility Research.”

New Fertility and Cancer Study from Oncofertility Consortium Member, Jennifer Mersereau, MD

Advances in cancer treatments give young women more hope for survival than ever before, but many treatments can leave women unable to naturally conceive a child.  The University of North Carolina (UNC) Fertility Preservation Program, a member of the National Physicians Cooperative, provides options for female patients of reproductive age newly diagnosed with cancer, but the decision to initiate fertility preservation must be made quickly, before cancer treatment begins.  General lack of knowledge about reproductive functioning, stress related to processing the cancer diagnosis, urgency, and insufficient support while attempting to make the decision, all serve to degrade this process often leading to later decisional regret.

As a result, Oncofertility Consortium member, Dr. Jennifer Mersereau, and UNC Fertility are conducting a multidisciplinary research study that evaluates a ‘Decision-Aid” designed to help reproductive-aged women (age 18-42) make decisions about fertility and cancer. This collaborative project between a reproductive endocrinologist, clinical psychologist, and oncology experts involves a new interactive, web-based decision aid that is used in concert with fertility preservation counseling.  If this decision aid proves to be beneficial, this web-based tool may potentially be used for patients who do not have easy access for a full fertility preservation consultation.

Study Details:

  • Study participants will have a routine consultation appointment with a fertility specialist at UNC Fertility to discuss fertility, cancer, and treatment options for fertility preservation. Note that this visit is considered part of routine medical care.
  • Participants will plan for an additional 45-60 minutes at the time of their consultation to watch a web-based presentation about fertility preservation and decision-making.  They will also complete questionnaires at that time.
  • Participants will be asked to complete 2 additional web-based surveys, one approximately one week after the consultation, and one approximately 6 months later.

Findings from this pilot evaluation will support a grant application for a multi-site study to investigate community effectiveness and accessibility. Study participants will receive a $50 gift card for full participation, to compensate for their time and effort. If you are in the Chapel Hill area and interested in taking part in this study, please call for a consultation appointment (919-966-1150) or send an email to jem *at* unc.edu with your name, phone number and times that you can be reached. Your contact information will not be shared with anyone outside the study. For more information about this study, please click here.

*Supported by a grant from the UNC Lineberger Cancer Center.

The Relationship between Pain, Opioids, and Hormonal Side Effects in Cancer Patients

Pain is a common symptom among cancer patients and a large percentage of cancer patients are treated with opioids to control this side effect. Some cancer therapies are very rigorous and require opioid analgesics on an ongoing basis to treat the pain resulting from aggressive treatment. Many cancer survivors also report having low energy, depression, anxiety and impaired sexual function as a result of their treatment. It is also known that cancer treatment, such as radiation to the brain, is associated with long term endocrine abnormalities, including hypogonadism and hypothyroidism, that may cause some of these symptoms. However, the relationship between long-term use of pain medication and hormonal disruption is still not well-understood in female cancer survivors.

Information from males was discussed in an older article in the journal, Cancer, by authors, Arun Rajagopal, MD, Rena Vassilopoulou-Sellin, J. Lynn Palmer, PhD, Guddi Kaur, RN, BSN, and Eduardo Bruera, MD, entitled, “Symptomatic Hypogonadism in Male Survivors of Cancer with Chronic Exposure to Opioids.” In the article, the authors explore the relationship between the chronic consumption of oral opioids during and after cancer treatment and the potential for hypogonadism (reduced testosterone levels) and whether or not hypogonadism is associated with symptoms of fatigue, anxiety, depression and sexual dysfunction.

In an effort to prove the prevalence of central hypogonadism and associated symptoms of sexual dysfunction, depression, anxiety and fatigue, cancer patients selected for the study were all adult males, who had been cancer free for a year, and  taking high does of opioids. The control population was selected based on matching diagnosis and treatment, albeit they had not consumed any opioids in the last 12 months.  Patients completed the Sexual Desire Inventory (SDI), the Hospital Anxiety and Depression Scale (HADS), the Functional Assessment of Chronic Illness Therapy (FACT-G/FACIT-F) and the Edmonton Symptom Assessment System (ESAS) questionnaires. The patients also had serum samples taken to monitor their testosterone levels.

The results of the study showed that testosterone levels in the study group were significantly lower than what was found in the control group. Sexual dysfunction was significantly higher in the opioid group and reports of depression and fatigue were also much higher in the study group. Reported anxiety between the two groups was insignificant. Thus, the results suggest that chronic consumption of opioids leads to clinically significant central hypogonadism, which also may lead to greater levels of depression, fatigue and sexual impairment.

The results of this study and potential implications for the quality of life in cancer patients is critical. Hypogonadism can have consequences that go beyond poor libido and affect other areas of men’s lives, including fertility. Unfortunately, there are a lack of studies examine the relationship between opioid use in female cancer survivors and endocrine health. As chemotherapy and radiation may already compromise a woman’s reproductive ability, this information would provide health care providers with critical information regarding how to treat two significant quality-of-life issues in young female cancer survivors: reproductive health and pain management.

© Oncofertility Consortium Blog