Pilot Study Comparing Hypnotherapy and Gabapentin for Hot Flashes.
Condition: Breast Cancer; Hot Flashes
MeSH terms: Breast Neoplasms; Hot Flashes
Intervention: Hypnotherapy; gabapentin
Intervention description: Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. surveys. The therapist will be prohibited from asking subjects about clinical responses to the hypnosis sessions. The patients will also be instructed on self-hypnosis techniques to be used at home.; Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily). This dose has been shown to be more effective than 300mg daily. Larger doses have not been evaluated in this population, and may be associated with a more significant side-effect profile. The prescription for gabapentin will be provided at the patient's enrollment appointment. The patients will take gabapentin as prescribed daily for the study-enrollment period, which is 8 weeks.
Intervention MeSH terms: Gabapentin
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hot flashes; breast cancer; Hypnotherapy; Quality of Life; Gabapentin

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.
    

Eligibility 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.