Sexual Health Clinical Trials


Clinical Trial Conversations
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In this series, we hope to cover promising trials that are enrolling, lessons learned from past research, logistics and resources to joining a clinical trial, and provide relevant and timely updates for our colon and rectal cancer community. 

Clinical Trials Focused on Sexual Health

For colorectal cancer (CRC) survivors and their caregivers, sex is rarely addressed before, during, or after treatment – and oftentimes, survivors are left alone to manage side effects that can completely alter both their sex life and fertility

Fortunately, the spotlight has shifted, and these conversations are becoming more and more common. Patients and their loved ones are speaking out and sharing their stories, advocating for better survivorship care to ensure that they can manage their health and make the most informed decisions. 

Not only are we talking about sex and cancer more, but there is research to better understand how to manage side effects, preserve fertility, and increase the quality of life for younger and older CRC survivors.

Maia and Manju, you both work closely with the CRC patient and caregiver community, do you hear a lot of concerns from the community about sexual health?

Yes, this is an important concern for patients, especially as rectal cancer rates in younger patients are climbing. Treatment modalities like radiation therapy have sexual side effects, which can interfere with quality of life for many patients. There is a lot of inconsistency of care around sexual health-related aspects in the U.S.: Some clinicians and hospitals do a great job of informing the patients what to expect and how they can manage side effects, while others don’t talk about the subject at all. For example, some centers promote and encourage the use of vaginal dilators in the body while the female patient is exposed to pelvic radiation – this is supposed to reduce radiation exposure to vagina, while other centers fail to even mention the use of dilators at home to prevent or reduce vaginal stenosis.

Sexual dysfunction following surgery is another aspect that is not discussed very well. The prevalence of sexual dysfunction following colon or rectal cancer resection seems to vary quite a bit, and I have heard this is more a problem in men than women.

What kind of research is being conducted right now that could help patients manage their sexual health?

Well-Being and Stress Control After Colorectal Surgery (C-Bien)

The main goal of this trial is to improve psychological well-being of CRC patients after surgery by offering stress management sessions to promote post-operative rehabilitation. They will also look at the impact of stress management sessions on the length of stay and to study the link between efficacy of sessions and quality of life before surgery. 

Stress management sessions consist of small exercises focused on breathing and bodily sensations. Each person has access to different exercises. The sessions are adapted to the state of the patient to promote their well-being, before or after their surgery. The preoperative session is for one hour, the post-operative sessions are 15 minutes each. Two questionnaires each will be used to assess general well-being and patient general quality of life measurement seven days before surgery and five days after surgery. Fatigue, sleep quality, pain assessment, and physical activity evaluations will also be done at these time points. Patients undergoing CRC surgery with or without prior radiation treatment are eligible, while ostomy reversal and emergency surgery are excluded. This trial is open in Strausberg, France.

The OPERa Study: Evaluating QoL After Rectal Cancer Surgery

The main aim of the trial is to collect information on the impact of Low Anterior Resection Syndrome (LARS), Sexual and Urinary Dysfunction (SUD), emotional/financial distress, and patient activation on long-term post-treatment Quality of Life (QoL) in North American rectal cancer patients after rectal surgery. LARS can be a bothersome and life-altering side effect of restorative rectal surgery to remove the cancer, and LARS includes increased stool frequency, incontinence, and difficult pooping. The reason this study is underway is because information on actual rates of these side effects, the risk factors, and prognosis are lacking in this patient population.

This 20-site North American, observational, prospective, 1200 patient cohort study uses validated patient reported outcome measures (PROMs) at diagnosis, during, and post-treatment. Patients will be recruited over two years and followed for three years. The research questions looked at include:

  1. How do North American rectal cancer patients who underwent rectal surgery experience changes in function (bowel, sexual and urinary), distress (emotional and financial) and QoL after surgery from baseline through early and late timepoints following treatment
  2. How do patient-, disease-, treatment-, functional- and distress-related factors predict QoL at baseline and at early and late timepoints post-treatment?

The primary endpoint is QoL as measured by questionnaires given to patients at early (12-18 months) and late (2-3 years) time points. The study involves a multidisciplinary team who will provide expertise in research methodology, nursing, oncology and surgery.

The main advances expected from this study are:

  1. Collection of baseline data for important rectal cancer PROMs for clinical and research use
  2. Figure out how  functional outcomes and QoL post-treatment changes to help counsel patients peri-operatively and throughout survivorship
  3. To provide the basis for future tailored programs to support rectal cancer survivors. Rectal cancer patients who can have curative intent treatment are eligible, people with metastatic disease or those planned to have abdominoperineal resection (APR) or pelvic exenteration surgery are not eligible.

Changes in Reproductive and Sexual Health in People With Early Onset Colorectal Cancer

This is a type of very important clinical trial that often goes unnoticed: an observational clinical trial. While interventional trials are specifically designed to evaluate the direct impacts of treatment or preventive measures on disease, observational clinical trials aim to get more information about populations, diseases, beliefs or behaviors, without any intervention.

This observational study ongoing at the Memorial Sloan Kettering Cancer Center (NY) includes women ages 18 to 40 diagnosed with colorectal cancer, and men ages 18 to 50 diagnosed with colorectal cancer, who are going to begin chemotherapy and/or radiation therapy for their cancer. That is, people with early onset colorectal cancer who are about to start treatment.
The researchers will observe and track changes in hormone levels and in sexual and reproductive health in the study participants. This information will help them learn more about how cancer treatments affect reproductive and sexual health, including the ability to have children (fertility).

By participating in an observational clinical trial, which in this case is as simple as a single blood draw and filling out a questionnaire, some patients choose to play an active role in the research that leads to better treatments.

Why is this important that we continue to discuss sexual health and put resources to improving the quality of life of patients?

Increasing numbers of survivors face long-term side effects of treatment, including sexual side effects. Most of these are quite manageable if patients are aware of what to expect, and how to treat or manage side effects. Lack of awareness of sexual side effects can lead to isolation, where people are unaware of how widespread the issues are or that they can be managed. Since sexual health and intimacy are not easy topics to discuss, patients and caregivers may suffer in silence. Because intimacy and sex are important and fulfilling aspects of the life – for those in a relationship, for those who are single, too. Sexual quality of life and body image are compromised during or after having colon or rectal cancer, and tend to remain impaired if unaddressed.

Any recommendations or resources for sexual health?

The COLONTOWN University Lecture Hall has a #DocTalk video focused on sexual health after treatment. In this talk, Dr. Sharon Bober talks about sexual health after treatment.

The Lecture Hall has a section on rectal cancer with videos on radiation therapy and proton therapy, and these talks also address some of the sexual health concerns around treatment.

Be sure to check out these Fight CRC resources:

One thought on “Sexual Health Clinical Trials

  1. All men having radiation and/or chemotherapy for CRC should have baseline testosterone measured before starting treatment. This will make it much easier to justify testosterone supplementation post-treatment if needed.

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