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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
Use of Gabapentin as a control intervention to evaluate the relative effects and adverse events of acupuncture for hot flashes
Abramson Cancer Center of the Unviersity of Pennsylvania
Philadelphia, Pennsylvania, United States
Daily Hot Flash Diary (DHFD)-Primary Outcome (2 minutes per day)
Time frame: Daily starting from baseline until week 12 and again for one week at week 24.
Demographics -Covariates
Time frame: 5 minutes
Hot Flash Related Daily Interference Scale (HFRDIS)-Secondary outcome
Time frame: 3 minutes
Pittsburgh Sleep Quality Index (PSQI) - Secondary outcome
Time frame: 6 minutes
Brief Fatigue Inventory (BFI) - Secondary Outcome
Time frame: 3 minutes
HADS - Secondary Outcome
Time frame: 2 minutes
Global Assessment Scale -Secondary Outcome
Time frame: 30 seconds
Acupuncture Expectancy Scale (AES) - Secondary Aim
Time frame: 1 minute
Creditability Rating of Acupuncture - Secondary Aim
Time frame: 1 minute
Medication and CAM Usage -Covariates
Time frame: 5 minutes
Actigraph Movement Measuring Device
Time frame: 24 hrs/day for 3 days
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