Clinical Trial: Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief Summary: 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).

Detailed Summary:
Sponsor: Abramson Cancer Center of the University of Pennsylvania

Current Primary Outcome: 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. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Abramson Cancer Center of the University of Pennsylvania

Dates:
Date Received: October 29, 2009
Date Started: January 2009
Date Completion:
Last Updated: January 24, 2017
Last Verified: January 2017