Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue
This is a randomized, placebo controlled study in cancer patients reporting fatigue persisting for at least two months following completion of chemotherapy. Subjects will receive 6 weeks of either acupuncture or placebo treatment as a means of evaluating whether acupuncture reduces chronic fatigue after chemotherapy.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue: a Randomized Phase III Trial|
- To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively than placebo [ Time Frame: six weeks ] [ Designated as safety issue: No ]
- To examine the long term effects of acupuncture treatment on fatigue [ Time Frame: six months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- To examine the effect of acupuncture on levels of physical activity and quality of life [ Time Frame: six months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2008|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Subjects will receive acupuncture weekly for six weeks. Subjects will complete a Brief Fatigue Inventory (BFI) questionnaire, a Functional Assessment of Cancer Treatment scale (FACT-G), and a Hospital Anxiety and Depression Scale(HADS) at week 7. The BFI and FACT-G will be repeated at week 8. At the end of the study, subjects will be asked to state whether they thought they were on true or placebo acupuncture and why.
Sham Comparator: 2
Procedure: Placebo Acupuncture
Subjects will receive placebo acupuncture weekly for six weeks. During the placebo phase, placebo acupuncture needles will be applied a few mm away from the required points. The placebo acupuncture needle is a blunt tipped needle that moves up inside its handle. When it is pressed against the skin, the subject feels a slight prick and sees the handle of the needle moving towards the skin as if the needle has been inserted.
Subjects will complete a BFI, a FACT-G, and a HADS at week 7. The BFI and FACT-G will be repeated at week 8. At the end of the study, subjects will be asked to state whether they thought they were on true or placebo acupuncture and why. Subjects in the placebo group will be given the option to receive true acupuncture.
|Contact: Amy Matecki, MD||(510) 204-6402||MateckA@Sutterhealth.org|
|Contact: Nick Humphrey, BA||(510) 204-3428||Humphrn2@sutterhealth.org|
|United States, California|
|Alta Bates Summit Comprehensive Cancer Center||Recruiting|
|Berkeley, California, United States, 94704|
|Contact: Clinical Trials Office 510-204-3428|
|Principal Investigator: Amy Matecki, MD|
|Sub-Investigator: Ji Jill Chen, MD|
|Principal Investigator:||Amy Matecki, MD||Alta Bates Summit Comprehensive Cancer Center|