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Chrysarobin

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.

Acupuncture and questionnaires

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.

placebo acupuncture

Gary Deng, MD, PhD

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. To examine the long-term effects of acupuncture treatment on fatigue
2. To examine predictors of response to acupuncture treatment in terms of baseline symptoms, hemoglobin, age, sex, time since chemotherapy and concurrent treatment
3. To examine the effect of acupuncture on levels of physical activity and quality of life.

Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue: A Randomized, Phase III Trial

Memorial Sloan Kettering Cancer Center

Gary Deng, MD,PhD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue: A Randomized, Phase III Trial	NCT00200096	Cancer	Acupuncture and... placebo acupunc...	18 Years - 64 Years	Memorial Sloan Kettering Cancer Center
Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue: A Randomized, Phase III Trial	NCT00200096	Cancer	Acupuncture and... placebo acupunc...	18 Years - 64 Years	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for acupuncture and questionnaires