Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors
Overview[ - collapse ][ - ]
Purpose | 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). |
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Condition | Hot Flashes |
Intervention | Drug: Gabapentin |
Phase | Phase 2 |
Sponsor | Abramson Cancer Center of the University of Pennsylvania |
Responsible Party | Abramson Cancer Center of the University of Pennsylvania |
ClinicalTrials.gov Identifier | NCT01005108 |
First Received | October 29, 2009 |
Last Updated | February 20, 2014 |
Last verified | February 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | October 29, 2009 |
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Last Updated Date | February 20, 2014 |
Start Date | January 2009 |
Estimated Primary Completion Date | February 2014 |
Current Primary Outcome Measures | 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.] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors |
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Official Title | Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors |
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 Provided |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Primary Purpose: Treatment |
Condition | 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 |
Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 124 |
Estimated Completion Date | February 2014 |
Estimated Primary Completion Date | February 2014 |
Eligibility Criteria | 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. |
Gender | Female |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01005108 |
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Other Study ID Numbers | UPCC 16108 |
Has Data Monitoring Committee | Yes |
Information Provided By | Abramson Cancer Center of the University of Pennsylvania |
Study Sponsor | Abramson Cancer Center of the University of Pennsylvania |
Collaborators | Not Provided |
Investigators | Principal Investigator: Jun J Mao, MD, MSCE Abramson Cancer Center of the University of Pennsylvania |
Verification Date | February 2014 |
Locations[ + expand ][ + ]
Abramson Cancer Center of the Unviersity of Pennsylvania | Philadelphia, Pennsylvania, United States, 19104 |
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