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Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00200096 |
In a previous study, we found that acupuncture may decrease fatigue. The aim of this study is to determine whether acupuncture is helpful in reducing fatigue in cancer patients treated with chemotherapy. We will also study how fatigue, quality of life, mood, level of physical activity. This study will involve about 88 patients.
Condition | Intervention | Phase |
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Cancer |
Procedure: Acupuncture and questionnaires Procedure: placebo acupuncture |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue: A Randomized, Phase III Trial |
Estimated Enrollment: | 150 |
Study Start Date: | July 2004 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Acupuncture and questionnaires
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Procedure: Acupuncture and questionnaires
Acupuncture once weekly for six weeks Brief Fatigue Inventory, Hospital Anxiety and Depression Scale, Functional Assessment of Cancer Treatment scale. Patients will repeat the BFI and FACT-G at seven and eight weeks after randomization, approximately one and two weeks after their final treatment. HADS will be repeated at week seven. At the end of the study, patients will be asked to state whether they were thought they on true or placebo acupuncture and why. On the day of the final session of acupuncture treatment (approximately day 35), blood samples will be collected and tested for hemoglobin, thyroid function tests, as described in pretreatment evaluation. The results will be designated "posttreatment" values. Actigraphic monitoring will be conducted in week seven. Patients will be asked to wear the device for seven days just like during baseline evaluation.
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2: Sham Comparator
placebo acupuncture and questionnaires
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Procedure: placebo acupuncture
During the placebo phase, placebo acupuncture needles (68) will be applied a few mm away from the points. The placebo acupuncture needle is a blunt tipped needle that moves up inside its handle. However, the needle does not penetrate the skin and instead moves upward inside the handle. Needles will be applied after sterile swabbing of the skin and kept in place for 20 minutes in both group.Patients in the placebo group will be offered true acupuncture after receipt of the week seven and eight fatigue diaries. Patients will complete the BFI, HADS and FACT-G at baseline, approximately two weeks before randomization and their first treatment. The BFI and FACT-G will be repeated after seven days, that is, one week before randomization. The use of repeat measurement decreases intrapatient variability and hence increases the precision of the baseline measure.
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Primary objective:
To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively than placebo
Secondary objectives:
Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Anemia is excluded as a major treatable cause of fatigue.
Contact: Gary Deng, MD, PhD | 646-888-0815 | Dengg@mskcc.org |
United States, New Jersey | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
Basking Ridge, New Jersey, United States | |
Contact: Gary Deng, MD dengg@mskcc.org | |
Principal Investigator: Gary Deng, MD | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Gary Deng, MD, PhD 646-888-0815 | |
Principal Investigator: Gary Deng, MD, PhD |
Principal Investigator: | Gary Deng, MD, PhD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan Kettering Cancer Center ( Gary Deng, MD,PhD ) |
Study ID Numbers: | 04-081 |
Study First Received: | September 9, 2005 |
Last Updated: | March 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00200096 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Cancer Fatigue |
Fatigue |