Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors
2 other identifiers
interventional
120
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2009
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 29, 2009
CompletedFirst Posted
Study publicly available on registry
October 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2014
CompletedApril 15, 2020
April 1, 2020
5.1 years
October 29, 2009
April 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
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
- +5 more secondary outcomes
Study Arms (4)
placebo pill
EXPERIMENTALplacebo accupuncture
EXPERIMENTALaccupuncture
EXPERIMENTALgabapentin
EXPERIMENTALInterventions
Use of Gabapentin as a control intervention to evaluate the relative effects and adverse events of acupuncture for hot flashes
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Abramson Cancer Center of the Unviersity of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Related Publications (3)
Romero SAD, Li QS, Orlow I, Gonen M, Su HI, Mao JJ. Genetic predictors to acupuncture response for hot flashes: an exploratory study of breast cancer survivors. Menopause. 2020 Aug;27(8):913-917. doi: 10.1097/GME.0000000000001545.
PMID: 32217888DERIVEDGarland SN, Xie SX, Li Q, Seluzicki C, Basal C, Mao JJ. Comparative effectiveness of electro-acupuncture versus gabapentin for sleep disturbances in breast cancer survivors with hot flashes: a randomized trial. Menopause. 2017 May;24(5):517-523. doi: 10.1097/GME.0000000000000779.
PMID: 27875389DERIVEDMao JJ, Bowman MA, Xie SX, Bruner D, DeMichele A, Farrar JT. Electroacupuncture Versus Gabapentin for Hot Flashes Among Breast Cancer Survivors: A Randomized Placebo-Controlled Trial. J Clin Oncol. 2015 Nov 1;33(31):3615-20. doi: 10.1200/JCO.2015.60.9412. Epub 2015 Aug 24.
PMID: 26304905DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jun J Mao, MD, MSCE
Abramson Cancer Center at Penn Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2009
First Posted
October 30, 2009
Study Start
January 1, 2009
Primary Completion
January 31, 2014
Study Completion
January 31, 2014
Last Updated
April 15, 2020
Record last verified: 2020-04