Clinical trial · Interventional
Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors
NCT01005108CI-TRIAL-00044676completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hot Flashes | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gabapentin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- placebo pill
- interventionNames
- Drug: Gabapentin
- type
- EXPERIMENTAL
- label
- placebo accupuncture
- interventionNames
- Drug: Gabapentin
- type
- EXPERIMENTAL
- label
- accupuncture
- interventionNames
- Drug: Gabapentin
- type
- EXPERIMENTAL
- label
- gabapentin
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- DERIVEDRomero 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 32217888
- DERIVEDGarland 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 27875389
- DERIVEDMao 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 26304905