Status:
COMPLETED
Pilot Study Comparing Hypnotherapy and Gabapentin for Hot Flashes.
Lead Sponsor:
Women and Infants Hospital of Rhode Island
Conditions:
Breast Cancer
Hot Flashes
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 sym...
Detailed Description
Roughly half of women diagnosed with pre-menopausal breast cancer will have hormone receptor-positive tumors, which will make them candidates for anti-estrogen therapies. Both endocrine therapy and ov...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00711529
Start Date
July 1 2008
End Date
June 1 2011
Last Update
June 24 2013
Active Locations (1)
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1
Breast Health Center, Program in Women's Oncology, Women & Infants' Hospital of Rhode Island
Providence, Rhode Island, United States, 02905