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Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors

Primary Purpose

Hot Flashes

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Gabapentin

About this trial

This is an interventional treatment trial for Hot Flashes focused on measuring Hot Flashes for Breast Cancer Patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Women 18 years or older with a history of Stage I, II or III breast cancer for at least 12 months.
Have been seen by an oncologist within the previous 6-month period and determined to be free of disease by clinical examination and history;
Experienced at least two hot flashes daily over the seven-day screening period as based on the Daily Hot Flash Diary.
Hot flashes have been present for at least a month before study entry.
Willing to use non-hormonal contraceptives during the duration of the study if patient is premenopausal.

Exclusion Criteria:

Having metastatic breast cancer ( IV)
Currently on chemotherapy or radiation therapy as adjuvant treatment
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.
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.
Current use of estrogen and/or progestin.
Pregnancy
Breast feeding
Bleeding disorder or current use of warfarin or heparin by patient history because of the use of needles.
Previous use of gabapentin for hot flashes.
Current use of any anti-convulsant.
Renal dysfunction defined as serum creatinine concentration above 1.25 times the upper limit of normal
Known allergy to gabapentin.

Sites / Locations

Abramson Cancer Center of the Unviersity of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

placebo pill

placebo accupuncture

accupuncture

gabapentin

Arm Description

Outcomes

Primary Outcome Measures

Daily Hot Flash Diary (DHFD)-Primary Outcome (2 minutes per day)

Secondary Outcome Measures

Demographics -Covariates

Hot Flash Related Daily Interference Scale (HFRDIS)-Secondary outcome

Pittsburgh Sleep Quality Index (PSQI) - Secondary outcome

Brief Fatigue Inventory (BFI) - Secondary Outcome

HADS - Secondary Outcome

Global Assessment Scale -Secondary Outcome

Acupuncture Expectancy Scale (AES) - Secondary Aim

Creditability Rating of Acupuncture - Secondary Aim

Medication and CAM Usage -Covariates

Actigraph Movement Measuring Device

Full Information

NCT ID

NCT01005108

First Posted

October 29, 2009

Last Updated

April 13, 2020

Sponsor

Abramson Cancer Center at Penn Medicine

1. Study Identification

Unique Protocol Identification Number

NCT01005108

Brief Title

Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors

Official Title

Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

January 2009 (Actual)

Primary Completion Date

January 31, 2014 (Actual)

Study Completion Date

January 31, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abramson Cancer Center at Penn Medicine

4. Oversight

Data Monitoring Committee

Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hot Flashes

Keywords

Hot Flashes for Breast Cancer Patients

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

placebo pill

Arm Type

Experimental

Arm Title

placebo accupuncture

Arm Type

Experimental

Arm Title

accupuncture

Arm Type

Experimental

Arm Title

gabapentin

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Gabapentin

Intervention Description

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

Primary Outcome Measure Information:

Title

Daily Hot Flash Diary (DHFD)-Primary Outcome (2 minutes per day)

Time Frame

Daily starting from baseline until week 12 and again for one week at week 24.

Secondary Outcome Measure Information:

Title

Demographics -Covariates

Time Frame

5 minutes

Title

Hot Flash Related Daily Interference Scale (HFRDIS)-Secondary outcome

Time Frame

3 minutes

Title

Pittsburgh Sleep Quality Index (PSQI) - Secondary outcome

Time Frame

6 minutes

Title

Brief Fatigue Inventory (BFI) - Secondary Outcome

Time Frame

3 minutes

Title

HADS - Secondary Outcome

Time Frame

2 minutes

Title

Global Assessment Scale -Secondary Outcome

Time Frame

30 seconds

Title

Acupuncture Expectancy Scale (AES) - Secondary Aim

Time Frame

1 minute

Title

Creditability Rating of Acupuncture - Secondary Aim

Time Frame

1 minute

Title

Medication and CAM Usage -Covariates

Time Frame

5 minutes

Title

Actigraph Movement Measuring Device

Time Frame

24 hrs/day for 3 days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women 18 years or older with a history of Stage I, II or III breast cancer for at least 12 months. Have been seen by an oncologist within the previous 6-month period and determined to be free of disease by clinical examination and history; Experienced at least two hot flashes daily over the seven-day screening period as based on the Daily Hot Flash Diary. Hot flashes have been present for at least a month before study entry. Willing to use non-hormonal contraceptives during the duration of the study if patient is premenopausal. Exclusion Criteria: Having metastatic breast cancer ( IV) Currently on chemotherapy or radiation therapy as adjuvant treatment 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. 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. Current use of estrogen and/or progestin. Pregnancy Breast feeding Bleeding disorder or current use of warfarin or heparin by patient history because of the use of needles. Previous use of gabapentin for hot flashes. Current use of any anti-convulsant. Renal dysfunction defined as serum creatinine concentration above 1.25 times the upper limit of normal Known allergy to gabapentin.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jun J Mao, MD, MSCE

Organizational Affiliation

Abramson Cancer Center at Penn Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Abramson Cancer Center of the Unviersity of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

32217888

Citation

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.

Results Reference

derived

PubMed Identifier

27875389

Citation

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.

Results Reference

derived

PubMed Identifier

26304905

Citation

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.

Results Reference

derived

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Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors

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