Clinical trial NCT01005108: Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors
Official title: Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hot Flashes
Keywords: Hot Flashes for Breast Cancer Patients
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2009-10-30
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Daily Hot Flash Diary (DHFD)-Primary Outcome (2 minutes per day)
timeFrame: Daily starting from baseline until week 12 and again for one week at week 24.
Secondary outcomes:
measure: Demographics -Covariates
timeFrame: 5 minutes
measure: Hot Flash Related Daily Interference Scale (HFRDIS)-Secondary outcome
timeFrame: 3 minutes
measure: Pittsburgh Sleep Quality Index (PSQI) - Secondary outcome
timeFrame: 6 minutes
measure: Brief Fatigue Inventory (BFI) - Secondary Outcome
timeFrame: 3 minutes
measure: HADS - Secondary Outcome
timeFrame: 2 minutes
measure: Global Assessment Scale -Secondary Outcome
timeFrame: 30 seconds
measure: Acupuncture Expectancy Scale (AES) - Secondary Aim
timeFrame: 1 minute
measure: Creditability Rating of Acupuncture - Secondary Aim
timeFrame: 1 minute
measure: Medication and CAM Usage -Covariates
timeFrame: 5 minutes
measure: Actigraph Movement Measuring Device
timeFrame: 24 hrs/day for 3 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the Unviersity of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Jun J Mao, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Garland 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.
citation: Mao 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.