Clinical Trials Directory

Trials / Unknown

UnknownNCT00658034

Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue

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

Status
Unknown
Phase
Phase 3
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
Alta Bates Summit Medical Center · Academic / Other
Sex
All
Age
18 Years – 64 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREAcupunctureSubjects 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.
PROCEDUREPlacebo AcupunctureSubjects 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.

Timeline

Start date
2008-04-01
Primary completion
2011-12-01
Completion
2011-12-01
First posted
2008-04-14
Last updated
2011-10-26

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00658034. Inclusion in this directory is not an endorsement.