Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors

Overview[ - collapse ][ - ]

Purpose 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).
ConditionHot Flashes
InterventionDrug: Gabapentin
PhasePhase 2
SponsorAbramson Cancer Center of the University of Pennsylvania
Responsible PartyAbramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov IdentifierNCT01005108
First ReceivedOctober 29, 2009
Last UpdatedFebruary 20, 2014
Last verifiedFebruary 2014

Tracking Information[ + expand ][ + ]

First Received DateOctober 29, 2009
Last Updated DateFebruary 20, 2014
Start DateJanuary 2009
Estimated Primary Completion DateFebruary 2014
Current Primary Outcome MeasuresDaily 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.] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • Demographics -Covariates [Time Frame: 5 minutes] [Designated as safety issue: No]
  • Hot Flash Related Daily Interference Scale (HFRDIS)-Secondary outcome [Time Frame: 3 minutes] [Designated as safety issue: No]
  • Pittsburgh Sleep Quality Index (PSQI) - Secondary outcome [Time Frame: 6 minutes] [Designated as safety issue: No]
  • Brief Fatigue Inventory (BFI) - Secondary Outcome [Time Frame: 3 minutes] [Designated as safety issue: No]
  • HADS - Secondary Outcome [Time Frame: 2 minutes] [Designated as safety issue: No]
  • Global Assessment Scale -Secondary Outcome [Time Frame: 30 seconds] [Designated as safety issue: No]
  • Acupuncture Expectancy Scale (AES) - Secondary Aim [Time Frame: 1 minute] [Designated as safety issue: No]
  • Creditability Rating of Acupuncture - Secondary Aim [Time Frame: 1 minute] [Designated as safety issue: No]
  • Medication and CAM Usage -Covariates [Time Frame: 5 minutes] [Designated as safety issue: No]
  • Actigraph Movement Measuring Device [Time Frame: 24 hrs/day for 3 days] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleAcupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors
Official TitleAcupuncture 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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 2
Study DesignPrimary Purpose: Treatment
ConditionHot Flashes
InterventionDrug: Gabapentin
Use of Gabapentin as a control intervention to evaluate the relative effects and adverse events of acupuncture for hot flashes
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment124
Estimated Completion DateFebruary 2014
Estimated Primary Completion DateFebruary 2014
Eligibility Criteria
Inclusion Criteria:

1. Women 18 years or older with a history of Stage I, II or III breast cancer for at
least 12 months.

2. Have been seen by an oncologist within the previous 6-month period and determined to
be free of disease by clinical examination and history;

3. Experienced at least two hot flashes daily over the seven-day screening period as
based on the Daily Hot Flash Diary.

4. Hot flashes have been present for at least a month before study entry.

5. Willing to use non-hormonal contraceptives during the duration of the study if
patient is premenopausal.

Exclusion Criteria:

1. Having metastatic breast cancer ( IV)

2. Currently on chemotherapy or radiation therapy as adjuvant treatment

3. 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.

4. 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.

5. Current use of estrogen and/or progestin.

6. Pregnancy

7. Breast feeding

8. Bleeding disorder or current use of warfarin or heparin by patient history because of
the use of needles.

9. Previous use of gabapentin for hot flashes.

10. Current use of any anti-convulsant.

11. Renal dysfunction defined as serum creatinine concentration above 1.25 times the
upper limit of normal

12. Known allergy to gabapentin.
GenderFemale
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT01005108
Other Study ID NumbersUPCC 16108
Has Data Monitoring CommitteeYes
Information Provided ByAbramson Cancer Center of the University of Pennsylvania
Study SponsorAbramson Cancer Center of the University of Pennsylvania
CollaboratorsNot Provided
Investigators Principal Investigator: Jun J Mao, MD, MSCE Abramson Cancer Center of the University of Pennsylvania
Verification DateFebruary 2014

Locations[ + expand ][ + ]

Abramson Cancer Center of the Unviersity of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104