Do We Need Another Trial?

Do We Need Another Trial?

Don S. Dizon, MD, FACP, FASCO

@drdonsdizon
Mar 22, 2018

Coauthored by Martha Goetsch, MD, MPH

I am just returning from the National Consortium of Breast Centers (NCoBC) Annual Meeting—a group (and a conference) very dear to me as I have had the good fortune of being a past program chair, but also a past president of the organization. Every time I go, I come back inspired by the attendees who come from all disciplines and specialties, and who gather here to learn from experts not necessarily from their own disciplines. Part of what we have done in the NCoBC is champion survivorship issues, and alongside fantastic colleagues Barbara Rabinowitz, RN, PhD, who also happens to be a certified sex therapist, and Anne Katz, RN, FAAN, PhD, a certified sexuality counselor and nurse counselor, we have aimed to raise awareness on sexual health needs of women and their partners who have undergone the experience of breast cancer. We call it the “Sexual Health First Responders’ Course” and I am pleased to say, we have had sustained interest in it!

As we planned this year’s meeting, I had one person in mind that I hoped would come: Dr. Martha Goetsch from the Oregon Health & Science University. She has been a longtime advocate of women’s health, and particularly issues around vulvar pain. Her expertise is well established, but it was one particular study that she led which spurred my interest in having her come—a randomized trial of 4% aqueous lidocaine to treat painful intercourse in breast cancer survivors.1 I recalled reading the study, published in the Journal of Clinical Oncology. She spoke of the vestibule: a 3-cm area in the inner vulva that could be exquisitely sensitive, and had assumed it was the source of pain for a significant number of women treated for breast cancer. She had used lidocaine in her routine practice in women with dyspareunia who could not otherwise tolerate a speculum exam, and found it made the exam tolerable. So she randomly assigned 46 women to lidocaine versus placebo, and used a mirror to teach women where the vestibule was and how to apply their solution. Among women who attempted intercourse, lidocaine resulted in a statistically significant reduction in pain compared to placebo (88% versus 38% less pain, p < 0.001). Pain with penetration went from pain level 8 to pain level 1 with lidocaine. When she moved to an open-label phase of the trial where all women were given lidocaine, of 20 women who abstained from intercourse due to pain, 17 (85%) had resumed comfortable penetrative intercourse. Ninety-five percent of the participants were having no pain with sex when they pre-treated with 3 minutes of lidocaine solution. The myth of “use it or lose it” when it comes to intercourse was shattered—all with a little lidocaine.

To my excitement, Dr. Goetsch did present her work at this year’s NCoBC meeting. It was thrilling to meet her in person, and to hear firsthand about her work. In my experience, this intervention has indeed been quite remarkable, and in the appropriate patient, it has been a godsend; saving marriages, increasing intimacy, and allowing patients and their partners to move forward after breast cancer, together.

At the conclusion of Dr. Goetsch’s talk, one of my esteemed colleagues and personal friends wondered whether she planned to pursue a larger randomized trial to document the benefit in a larger sample. At this, I got up and spoke. “I’ve seen it work in the right patient—determined only by taking a history and performing a pelvic exam, mind you. Anecdotally at least, the response has been immediate and pretty incredible. Given the magnitude of benefit in this trial—albeit a small one—coupled with the ease of administration (once you teach women how it should be applied), and the potential and immediate impact it can have, at least where this is concerned, I don’t think a larger trial is needed.”

I wish I could say the same thing for much that we do in oncology. But, here it was. Thank you, Dr. Goetsch, for your important contribution to the lives of women with cancer!

Dr. Goetsch:

Thank you, Don, for your kind words and for finding that your patients have the same successes in preventing intimacy pain when they are taught to pre-treat with liquid lidocaine. I can mention the issue of research funding in telling how I came to do my study. For several decades I have focused my clinical research on the problem of painful sex, first with young women who have the condition called localized provoked vulvodynia. The recognition that the location of pain is the vestibule led me to always check that area when seeing patients with complaints of penetration pain. Women who were post-menopausal typically had pain in the same inner vulvar location and not in the vagina, as is generally assumed. I could certainly relieve their pain by prescribing estrogen therapy, but for years I wondered about those who should not use estrogen, i.e., breast cancer survivors.

The field of sexual pain research is not well funded, perhaps because for years the prevalence and severity of this very private problem were not recognized. Also, for decades the theory about this pain in post-menopausal women was that it was a problem of “dryness.” That does not sound very severe. Lubricants are always suggested, as if they work fine. I wished to study breast cancer survivors because they would represent the population which has the most significant signs and symptoms of lack of estrogen and should reveal the location of pain and whether it can be briefly extinguished by lidocaine.

I knew that to pursue funding, I would have to defend a totally new theory that the pain from low estrogen is a nerve condition in the vestibule rather than pain from vaginal atrophy. I knew I would have to get local money, and luckily, there is a generous group of donor women who support research at our Center for Women’s Health at OHSU. Two of my survivor patients who had complete success with lidocaine wrote letters in support of my study. I got funding to study 50 participants, and the results were even better than I predicted. I agree with Don that a 95% success rate in a randomized controlled trial means that it should not have to be repeated for validity. But there are so many other aspects to study.

We need outcome studies to look at the success of lidocaine therapy in survivors who are instructed by clinicians other than a vulvar expert, since I, for instance, have studied those 3 square inches for decades. So yes, bigger studies are indeed needed. Which practitioners will do the best teaching? Nurse practitioners? Women’s health physical therapists? Gynecologists? What role could lidocaine play in treatment of pelvic or rectal cancers? In successful use of dilators after radiation?

Also, since we know that the vestibule keeps getting crankier and crankier with more and more years with no estrogen, what are the later pain symptoms in long-term estrogen-avoiding survivors? Shouldn’t survivorship studies incorporate questions about intimacy and vulvar pain, both the pain provoked by touch and the pain that comes later and is spontaneous?

Now that there is a “simple solution” to prevent the pain, we can hope that clinicians can be emboldened to ask or have their staff ask survivors about this pain which is a quiet source of grief. Don, thank you so much for hosting me at this excellent NCoBC conference.

Reference

  1. Goetsch MF, Lim JY, Caughey AB. A practical solution for dyspareunia in breast cancer survivors: a randomized controlled trial. J Clin Oncol. 2015;33:3394-400.

 

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