Reader Q&A: No Libido Treatment Studies on Breast Cancer Patients?

By on September 18th, 2015 Categories: Sex Matters

For this month’s column we wanted to address some important questions from readers. With the approval of flibanserin (brand name: Addyi), many questions have arisen concerning sexuality research, sexual desire, and cancer treatment. In addition, some women are asking about sexual desire after breast cancer treatment and possible time to resolution of symptoms.

Why have there not been studies done on breast cancer patients to treat lowered sexual interest?

Traditionally, most clinical trials that involve medications for sexuality have excluded the breast cancer population for a variety of different reasons. Firstly, testosterone, which has been widely studied in the female population, has excluded breast cancer patients due to the concern that testosterone is a hormone and is converted to estrogen. Many breast cancer tumors actually do have androgen or testosterone receptors, too. Systemic hormones are not recommended in the breast cancer population. There is an underlying concern of reactivation of a dormant cancer or stimulation of cancer cells with hormones (either estrogen or testosterone). Many experts are concerned about hormones in light of a breast cancer diagnosis given that many tumors have estrogen receptors.

Secondly, sexual problems have been defined as problems in desire, arousal, orgasms, and/or pain that are unrelated to an underlying medical condition. What this means is that an underlying medical condition such as breast cancer can have both direct and indirect effects on the sexual response cycle and may interfere with the study. Breast cancer causes a variety of effects that can affect sexuality: surgical removal of the breast, scarring, radiation effects of the skin, chemotherapy side effects, and sexual self-esteem changes are a few facets that can independently affect sexual responsivity. Premature menopause can cause atrophic and dry vaginal and vulvar tissues, which can impact sexual comfort as well. All these factors can act as complicating features to a clinical study. Breast cancer patients may have more than one contributing facet to their overall sexual functioning. It’s often not easy to tease out what factor is contributing to the problem at a given moment.

The third reason is that many drugs may have some adverse breast effects in one species or another. Many researchers are unwilling to add any risk (even if it small or unknown) to the breast cancer population. For example, from Addyi, or flibanserin’s, product label:

“Mammary Tumors in Female Mice: In a 2-year carcinogenicity study in mice, there was a statistically significant and dose-related increase in the incidence of malignant mammary tumors in female mice at exposures 3 and 10 times the recommended clinical dose. No such increases were seen in male mice or in male or female rats. The clinical significance of these findings is unknown.”

True! Women are not mice or rats. And this was 3 to 10 times the dose of what is traditionally given to women. However, many researchers feel that even this POTENTIAL, SMALL, and UNSTUDIED risk is unacceptable for women who are already diagnosed with cancer.

Do you foresee a breast cancer trial for flibanserin?

It is my hope and aspiration that breast cancer patients will be allowed in post-approval studies for drugs that have been shown to be effective for the treatment of female sexual dysfunction. It is estimated that between 50 and 90% of women with breast cancer suffer from distressing sexual problems and the approved treatment options are limited.

Of course, we want to ensure several facets before jumping in full force and endorsing any medication for the breast cancer population.

We want to make sure that the drug is effective, safe, and that the benefits outweigh the risks.  The treatment of sexual problems is often best tackled by a multifaceted approach that uses medications coupled with therapy and behavioral techniques. Flibanserin (Addyi) is a non-hormonal medication and has been shown to be effective in large clinical trials of over 11,000 women. It has good results that show improvement in desire, decreased distress, and an increase in satisfying sexual events. It is not a cure-all, nor will it help every woman, and it has NOT been studied in breast cancer patients. Not yet, at least!

What is essential, of course, is that each woman must weigh the benefits versus risks with every medication in consultation with her healthcare team. Medications that treat sexuality are no different. Flibanserin also does have side effects including sleepiness, fatigue, and dizziness. Alcohol is not recommended when taking flibanserin.

Is sexual desire a permanent problem after chemotherapy or does it go away on its own without medication?

Sexual desire or interest is a human emotional experience and phenomena that can wax and wane with time. Certainly we’ve all experienced lowered sexual interest during certain periods of our lives. Stress from work deadlines, financial constraints, lack of privacy, and relationship hardships all can drain our interest in being sexual. Sometimes sexual interest can be revived and restored, and it may get better with time or as certain life situations change.

In my clinical practice, I have seen many women experience a sexual revival with divorce and/or ending a destructive relationship. For others, desire problems aren’t based in a specific situation but may be based in physiological issues such as hormonal shifts or changes in brain chemicals called neurotransmitters. To better understand the issues with sexual problems, here are some helpful terms:

  • A situational problem is one that occurs during certain specific situations or with certain partners. For example, a woman may be able to achieve orgasm with her self-stimulator, but not with her boyfriend.
  • A generalized problem is a sexual functioning problem that occurs in all sexual situations and with all partners. This means no arousal with self-stimulation or partners.
  • A lifelong (primary) problem is any sexual problem that has always been present. This means that lowered sexual interest has always been an issue.
  • An acquired (secondary) problem means any sexual problem that follows a period of normal sexual desire. For instance, a woman who had normal desire before breast cancer treatment who then develops distressing lowered sexual interest after treatment has an acquired sexual problem.

Desire can wax and wane, improve, or worsen with time. Sometimes, time heals the problem, when other times it’s only made worse with watchful waiting. Sexual desire problems can be treated, and no woman experiencing distress in her sexual life should be forced to suffer in silence. Help is available, and healthcare professionals are listening!

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Do you have a question for Dr. Krychman? Post it in the comments area below.

Michael L. Krychman, M.D.C.M., is the executive director of the Southern California Center for Sexual Health and Survivorship Medicine in Newport Beach, California. He is the former co-director of the Sexual Medicine and Rehabilitation Program at Memorial Sloan-Kettering Cancer. Dr. Krychman is also an American Association of Sexuality Educators, Counselors and Therapists (AASECT) certified sexual counselor. He is an associate clinical professor at the University of California, Irvine, Division of Gynecological Oncology, and the medical director of Ann’s Clinic, a high-risk program for breast and ovarian cancer survivors. His special interests include menopausal health, hormone therapy, sexual pain disorders, loss of libido, and chronic medical illness and its impact on female sexual function as well as breast cancer sexuality. Dr. Krychman is also a member of the Breastcancer.org Professional Advisory Board.

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