Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors

• Sponsor: Abramson Cancer Center of the University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT01005108
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 4
• Actual Duration (Months): 61
• Patients Per Site Per Month: 2

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Hot Flashes	Drug: Gabapentin	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors
• Actual Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Jan 31, 2014
• Actual Study Completion Date: Jan 31, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Demographics -Covariates [5 minutes]

2. Hot Flash Related Daily Interference Scale (HFRDIS)-Secondary outcome [3 minutes]

3. Pittsburgh Sleep Quality Index (PSQI) - Secondary outcome [6 minutes]

4. Brief Fatigue Inventory (BFI) - Secondary Outcome [3 minutes]

5. HADS - Secondary Outcome [2 minutes]

6. Global Assessment Scale -Secondary Outcome [30 seconds]

7. Acupuncture Expectancy Scale (AES) - Secondary Aim [1 minute]

8. Creditability Rating of Acupuncture - Secondary Aim [1 minute]

9. Medication and CAM Usage -Covariates [5 minutes]

10. Actigraph Movement Measuring Device [24 hrs/day for 3 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center of the Unviersity of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Abramson Cancer Center of the University of Pennsylvania

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abramson Cancer Center of the University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT01005108
• Other Study ID Numbers: UPCC 16108; NCI-2009-01315
• First Posted: Oct 30, 2009
• Last Update Posted: Apr 15, 2020
• Last Verified: Apr 1, 2020

• Keywords provided by Abramson Cancer Center of the University of Pennsylvania: Hot Flashes for Breast Cancer Patients
• Additional relevant MeSH terms: Hot Flashes; Gabapentin

Study Results

No Results Posted as of Apr 15, 2020