Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors
This study is currently recruiting participants.
Verified May 2012 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
Abramson Cancer Center of the University of Pennsylvania
Information provided by:
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01005108
First received: October 29, 2009
Last updated: May 17, 2012
Last verified: May 2012
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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 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors |
Resource links provided by NLM:
Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:
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 ]
Secondary Outcome Measures:
- Demographics -Covariates [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
- Hot Flash Related Daily Interference Scale (HFRDIS)-Secondary outcome [ Time Frame: 3 minutes ] [ Designated as safety issue: No ]
- Pittsburgh Sleep Quality Index (PSQI) - Secondary outcome [ Time Frame: 6 minutes ] [ Designated as safety issue: No ]
- Brief Fatigue Inventory (BFI) - Secondary Outcome [ Time Frame: 3 minutes ] [ Designated as safety issue: No ]
- HADS - Secondary Outcome [ Time Frame: 2 minutes ] [ Designated as safety issue: No ]
- Global Assessment Scale -Secondary Outcome [ Time Frame: 30 seconds ] [ Designated as safety issue: No ]
- Acupuncture Expectancy Scale (AES) - Secondary Aim [ Time Frame: 1 minute ] [ Designated as safety issue: No ]
- Creditability Rating of Acupuncture - Secondary Aim [ Time Frame: 1 minute ] [ Designated as safety issue: No ]
- Medication and CAM Usage -Covariates [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
- Actigraph Movement Measuring Device [ Time Frame: 24 hrs/day for 3 days ] [ Designated as safety issue: No ]
| 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) |
Intervention Details:
-
Drug: Gabapentin
Use of Gabapentin as a control intervention to evaluate the relative effects and adverse events of acupuncture for hot flashes
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005108
Contacts
| Contact: Jun J Mao, MD, MSCE | (215) 615-4330 | Jun.Mao@uphs.upenn.edu |
Locations
| 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 | |
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
| Principal Investigator: | Jun J Mao, MD, MSCE | Abramson Cancer Center of the University of Pennsylvania |
More Information
No publications provided
| 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: | May 17, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
|
Hot Flashes for Breast Cancer Patients |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 19, 2013