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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-01315 |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo pill | Experimental |
| |
| placebo accupuncture | Experimental |
| |
| accupuncture | Experimental |
| |
| gabapentin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | Use of Gabapentin as a control intervention to evaluate the relative effects and adverse events of acupuncture for hot flashes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Demographics -Covariates | 5 minutes | |
| Hot Flash Related Daily Interference Scale (HFRDIS)-Secondary outcome | 3 minutes | |
| Pittsburgh Sleep Quality Index (PSQI) - Secondary outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun J Mao, MD, MSCE | Abramson Cancer Center at Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of the Unviersity of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32217888 | Derived | 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. | |
| 27875389 | Derived | 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. |
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| 6 minutes |
| Brief Fatigue Inventory (BFI) - Secondary Outcome | 3 minutes |
| HADS - Secondary Outcome | 2 minutes |
| Global Assessment Scale -Secondary Outcome | 30 seconds |
| Acupuncture Expectancy Scale (AES) - Secondary Aim | 1 minute |
| Creditability Rating of Acupuncture - Secondary Aim | 1 minute |
| Medication and CAM Usage -Covariates | 5 minutes |
| Actigraph Movement Measuring Device | 24 hrs/day for 3 days |
| 26304905 | Derived | 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. |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |