A Phase 3 interventional study of Acupuncture and questionnaires and placebo acupuncture in Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 2 sites in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2011-02-15.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 3 and Interventional
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.
Primary objective:
To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively than placebo
Secondary objectives:
1,859 studies on the registry are indexed under Fatigue; 376 are open to participants now.
This study's enrollment of 101 is above the median of 54 across 1,439 interventional studies indexed under Fatigue.
Browse Fatigue studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 66 (52%) have results posted.
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Exclusion Criteria:
Acupuncture and questionnaires
Procedure: Acupuncture and questionnaires
placebo acupuncture and questionnaires
Procedure: placebo acupuncture
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.
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.
To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively than placebo
Time frame: six weeks
To examine the long-term effects of acupuncture treatment on fatigue
Time frame: six months
To examine predictors of response to acupuncture treatment in terms of baseline symptoms, hemoglobin, age, sex, time since chemotherapy and concurrent treatment
Time frame: six months
To examine the effect of acupuncture on levels of physical activity and quality of life.
Time frame: six months
This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.
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Memorial Sloan Kettering Cancer Center