Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue
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|ClinicalTrials.gov Identifier: NCT00658034|
Recruitment Status : Unknown
Verified October 2011 by Alta Bates Summit Medical Center.
Recruitment status was: Recruiting
First Posted : April 14, 2008
Last Update Posted : October 26, 2011
|Condition or disease||Intervention/treatment||Phase|
|Fatigue||Procedure: Acupuncture Procedure: Placebo Acupuncture||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue: a Randomized Phase III Trial|
|Study Start Date :||April 2008|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||December 2011|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658034
|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|