Pilot Study Comparing Hypnotherapy and Gabapentin for Hot Flashes.
Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
Participant gender:
Summary
Premenopausal women with breast cancer who receive endocrine therapy (e.g. tamoxifen) and/or
chemotherapy are at risk for experiencing premature menopause because of their treatment. The
resulting symptoms, most notably hot flashes, can cause significant detriment to a patient's
quality of life. Treatment for menopausal symptoms with the gold standard of hormone
replacement therapy is not done routinely as it is unclear whether it can increase risk of
tumor recurrence. In addition, many medical oncologists feel it is contraindicated in this
population, especially among women whose breast cancers have estrogen receptors. This has
lead to an increased interest in options other than estrogen replacement in the treatment of
hot flashes, though most investigations of alternative medications have shown a suboptimal
response.
Recent studies have suggested that non-drug treatments using alternative or complementary
therapies may be effective. Specifically, hypnosis has been promoted as a means to control
hot flashes, though it has not been tested in a randomized fashion. In accordance with the
National Cancer Institute's recent initiatives to expand the goals of clinical trials to
include symptom management studies, our purpose is to evaluate the role of complementary and
alternative therapies for improvement of symptoms in women with breast cancer. Specifically,
we plan to evaluate the use of hypnotherapy for the treatment of therapy-induced hot flashes
in breast cancer survivors. We intend to recruit 60 women into a pilot feasibility trial
comparing hypnotherapy to the drug gabapentin (Neurontin®) for the treatment of
therapy-induced hot flashes in eligible women who are receiving care at the Breast Health
Center. We have chosen gabapentin based on recent studies showing it may be an effective
non-estrogen treatment for this indication.
We will identify patients who are experiencing at least one daily hot flash as a result of
the treatment they received for their breast cancer for participation. When enrolled, they
will be randomized into either the treatment arm, in which they will receive daily
gabapentin, or the experimental arm, in which they will undergo weekly hypnotherapy.
Our study hypothesis is that hypnotherapy will be more effective than gabapentin in the
control of hot flashes in this population.