Pilot Study Comparing Hypnotherapy and Gabapentin for Hot Flashes.

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Women and Infants Hospital of Rhode Island
• Treatments: Gabapentin; gamma-Aminobutyric Acid

Criteria

Inclusion criteria:

• Women with histologic confirmation of a diagnosis of infiltrating carcinoma of the breast are eligible for participation.

• Women with non-invasive or pre-invasive lesions of the breast, including but not limited to ductal carcinoma in situ (DCIS), atypical ductal hyperplasia (ADH) or lobular carcinoma in situ (LCIS) are eligible for participation.

• Women with a known breast cancer susceptibility gene (eg, BRCA) mutation or strong family history of breast cancer are eligible.

• Any woman age 60 years or more who cannot take estrogen therapy because of a real or perceived risk of developing breast cancer are eligible.

• Women under the age of 60 with a Gail model score of 1.6% or more are eligible.

• Subjective report of at least one daily hot flash.

• Able to provide voluntary informed consent.

• ≥ 18 years-old. There will be no upper limit for age inclusion.

• Karnofsky performance status > 70%.

• Women with a history of breast cancer must have undergone treatment with curative intent.

• ≥ 4 weeks from completion of chemotherapy or radiation therapy, where appropriate.

• adequate hematopoietic function (ANC ≥ 1500/mm3; Platelets ≥ 100,000/mm3; Hemoglobin ≥ 8 g/dL)

• adequate renal and hepatic function [Bilirubin ≤ 1.5 times upper limit of normal (ULN), serum glutamic-oxaloacetic transaminase (SGOT) ≤ 2.5x ULN, Alkaline phosphatase ≤ 2.5x ULN, and Creatinine ≤ 2x ULN].

• No clinical evidence of disease (complete remission).

• Patients receiving neoadjuvant therapy will be eligible following completion of all adjuvant chemotherapy if indicated.

• Patients receiving hormonal therapy in lieu of or following chemotherapy will be eligible to participate.

• Patients must have access to a compact disk player.

Exclusion criteria:

• History or active secondary cancer within the last 5 years (except for superficial basal cell skin cancers).

• Any residual chemotherapy-induced CTCv3.0 Grade 2 or greater non-hematological toxicity.

• Unable to give informed consent or unable to adhere to protocol.

• Any serious medical or psychiatric illness likely to interfere with participation in this clinical study, concurrent uncontrolled illness, or ongoing or active infection will be excluded.

• Any history of alcohol or drug abuse.

• Allergy to gabapentin.

• History of seizure disorder.