Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors - NCT01005108-19104 (Clinical Trial 386026)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy386026.aspx
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Philadelphia |
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State:
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PA |
| Zip Code: |
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19104 |
| Conditions: |
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Hot Flashes |
| Purpose: |
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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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| Study summary: |
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| Criteria: |
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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. |
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| Study is available at: |
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Abramson Cancer Center of the Unviersity of Pennsylvania
Philadelphia, PA 19104
United States
Primary Contact:
Jun J Mao, MD, MSCE
Email: Jun.Mao@uphs.upenn.edu
Phone: 215-615-4330
Secondary Contact:
Jun J Mao, MD, MSCE
Email: Jun.Mao@uphs.upenn.edu
Phone: (215) 615-4330 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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