Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors

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).

Study Overview

• Status: Completed
• Conditions: Hot Flashes
• Intervention / Treatment: Drug: Gabapentin

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Abramson Cancer Center of the Unviersity of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: placebo pill	Drug: Gabapentin; Use of Gabapentin as a control intervention to evaluate the relative effects and adverse events of acupuncture for hot flashes
Experimental: placebo accupuncture	Drug: Gabapentin; Use of Gabapentin as a control intervention to evaluate the relative effects and adverse events of acupuncture for hot flashes
Experimental: accupuncture	Drug: Gabapentin; Use of Gabapentin as a control intervention to evaluate the relative effects and adverse events of acupuncture for hot flashes
Experimental: gabapentin	Drug: Gabapentin; Use of Gabapentin as a control intervention to evaluate the relative effects and adverse events of acupuncture for hot flashes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
Global Assessment Scale -Secondary Outcome	30 seconds
Acupuncture Expectancy Scale (AES) - Secondary Aim	1 minute
Creditability Rating of Acupuncture - Secondary Aim	1 minute
Medication and CAM Usage -Covariates	5 minutes
Actigraph Movement Measuring Device	24 hrs/day for 3 days

Collaborators and Investigators

• Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Investigators: Principal Investigator: Jun J Mao, MD, MSCE, Abramson Cancer Center of the University of Pennsylvania

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2009
• Primary Completion (Actual): January 31, 2014
• Study Completion (Actual): January 31, 2014

Study Registration Dates

• First Submitted: October 29, 2009
• First Submitted That Met QC Criteria: October 29, 2009
• First Posted (Estimate): October 30, 2009

Study Record Updates

• Last Update Posted (Actual): April 15, 2020
• Last Update Submitted That Met QC Criteria: April 13, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Hot Flashes for Breast Cancer Patients
• Additional Relevant MeSH Terms: Hot Flashes; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: UPCC 16108; NCI-2009-01315