Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors

Abramson Cancer Center at Penn Medicine

Status and phase: Completed; Phase 2

Conditions: Hot Flashes

Treatments: Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT01005108

UPCC 16108

NCI-2009-01315

Details and patient eligibility

About

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).

Enrollment: 120 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 4 patient groups

placebo pill

Experimental group

Treatment:

Drug: Gabapentin

placebo accupuncture

Experimental group

Treatment:

Drug: Gabapentin

accupuncture

Experimental group

Treatment:

Drug: Gabapentin

gabapentin

Experimental group

Treatment:

Drug: Gabapentin