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| Sponsor: | Abramson Cancer Center of the University of Pennsylvania |
|---|---|
| Information provided by: | Abramson Cancer Center of the University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01005108 |
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Hot Flashes |
Drug: Gabapentin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors |
| Estimated Enrollment: | 124 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jun J Mao, MD, MSCE | (215) 615-4330 | Jun.Mao@uphs.upenn.edu |
| United States, Pennsylvania | |
| Abramson Cancer Center of the Unviersity of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Jun J Mao, MD, MSCE 215-615-4330 Jun.Mao@uphs.upenn.edu | |
| Principal Investigator: | Jun J Mao, MD, MSCE | Abramson Cancer Center of the University of Pennsylvania |
More Information
| Responsible Party: | Jun James Mao, MD, Abramson Cancer Center of the University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01005108 History of Changes |
| Other Study ID Numbers: | UPCC 16108, NCI-2009-01315 |
| Study First Received: | October 29, 2009 |
| Last Updated: | November 9, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Hot Flashes for Breast Cancer Patients |
|
Breast Neoplasms Hot Flashes Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Signs and Symptoms Gabapentin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Anticonvulsants Antiparkinson Agents Anti-Dyskinesia Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Antimanic Agents |