Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors

Study Overview
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Brief Summary
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Overall Objectives: The overarching goal is to compare the effectiveness of acupuncture and gabapentin to their respective placebo controls in the treatment of hot flashes in breast cancer patients. The investigators primary specific aim will focus on determining the magnitude of response to placebo acupuncture versus placebo pills on hot flashes (HFs).

Official Title
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Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors

Conditions
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Hot Flashes

Intervention / Treatment
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* Drug: Gabapentin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women 18 years or older with a history of Stage I, II or III breast cancer for at least 12 months. Have been seen by an oncologist within the previous 6-month period and determined to be free of disease by clinical examination and history; Experienced at least two hot flashes daily over the seven-day screening period as based on the Daily Hot Flash Diary. Hot flashes have been present for at least a month before study entry. Willing to use non-hormonal contraceptives during the duration of the study if patient is premenopausal. Exclusion Criteria: Having metastatic breast cancer ( IV) Currently on chemotherapy or radiation therapy as adjuvant treatment Started hormonal therapies such as tamoxifen or aromatase inhibitors within the last 4 weeks; or plan to change or terminate hormonal therapies in the next 14 weeks. Started or changed with treatments for hot flashes, such as SSRIs or clonidine within the last 4 weeks; or plan to change or terminate these therapies in the next 14 weeks. Current use of estrogen and/or progestin. Pregnancy Breast feeding Bleeding disorder or current use of warfarin or heparin by patient history because of the use of needles. Previous use of gabapentin for hot flashes. Current use of any anti-convulsant. Renal dysfunction defined as serum creatinine concentration above 1.25 times the upper limit of normal Known allergy to gabapentin.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: placebo pill<br> | Drug: Gabapentin<br>* Use of Gabapentin as a control intervention to evaluate the relative effects and adverse events of acupuncture for hot flashes<br>|
| Experimental: placebo accupuncture<br> | Drug: Gabapentin<br>* Use of Gabapentin as a control intervention to evaluate the relative effects and adverse events of acupuncture for hot flashes<br>|
| Experimental: accupuncture<br> | Drug: Gabapentin<br>* Use of Gabapentin as a control intervention to evaluate the relative effects and adverse events of acupuncture for hot flashes<br>|
| Experimental: gabapentin<br> | Drug: Gabapentin<br>* Use of Gabapentin as a control intervention to evaluate the relative effects and adverse events of acupuncture for hot flashes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Hot Flash Diary (DHFD)-Primary Outcome (2 minutes per day) |  | Daily starting from baseline until week 12 and again for one week at week 24. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographics -Covariates |  | 5 minutes | 
| Hot Flash Related Daily Interference Scale (HFRDIS)-Secondary outcome |  | 3 minutes | 
| Pittsburgh Sleep Quality Index (PSQI) - Secondary outcome |  | 6 minutes | 
| Brief Fatigue Inventory (BFI) - Secondary Outcome |  | 3 minutes | 
| HADS - Secondary Outcome |  | 2 minutes | 
| Global Assessment Scale -Secondary Outcome |  | 30 seconds | 
| Acupuncture Expectancy Scale (AES) - Secondary Aim |  | 1 minute | 
| Creditability Rating of Acupuncture - Secondary Aim |  | 1 minute | 
| Medication and CAM Usage -Covariates |  | 5 minutes | 
| Actigraph Movement Measuring Device |  | 24 hrs/day for 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hot Flashes for Breast Cancer Patients