Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors

Phase 2

Completed

• Conditions: Hot Flashes
• Interventions: Drug: Gabapentin

• Registration Number: NCT01005108
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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 Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-10-29
• Study First Submitted QC: 2009-10-29
• Study First Posted: 2009-10-30
• Primary Completion: 2014-01-31
• Study Completion: 2014-01-31
• Status Verified: 2020-04
• Disposition First Submitted: 2020-04-13
• Disposition First Submitted QC: 2020-04-13
• Last Update Submitted: 2020-04-13
• Disposition First Posted: 2020-04-15
• Last Update Posted: 2020-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo accupuncture	Gabapentin	-
accupuncture	Gabapentin	-
placebo pill	Gabapentin	-
gabapentin	Gabapentin	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Brief Fatigue Inventory (BFI) - Secondary Outcome	3 minutes
Creditability Rating of Acupuncture - Secondary Aim	1 minute
Demographics -Covariates	5 minutes
Acupuncture Expectancy Scale (AES) - Secondary Aim	1 minute
Actigraph Movement Measuring Device	24 hrs/day for 3 days
Hot Flash Related Daily Interference Scale (HFRDIS)-Secondary outcome	3 minutes
Pittsburgh Sleep Quality Index (PSQI) - Secondary outcome	6 minutes
Global Assessment Scale -Secondary Outcome	30 seconds
Medication and CAM Usage -Covariates	5 minutes
HADS - Secondary Outcome	2 minutes

Trial Locations

Locations (1)

Abramson Cancer Center of the Unviersity of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States