Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors

Hot Flashes Clinical Trial

Official title:

Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01005108
• Other study ID #: UPCC 16108
• Secondary ID: NCI-2009-01315
• Status: Completed
• Phase: Phase 2
• Start date: January 2009
• Est. completion date: January 31, 2014

Study information

• Verified date: April 2020
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 31, 2014
• Est. primary completion date: January 31, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hot Flashes

Intervention

Drug:
• Gabapentin
Use of Gabapentin as a control intervention to evaluate the relative effects and adverse events of acupuncture for hot flashes

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the Unviersity of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

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