Fatigue | Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue
Fatigue research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - Patients age 18-64 diagnosed with a malignancy (solid tumor or hematologic malignancy). - Patients must have received chemotherapy. - Patients must complain of fatigue following chemotherapy buy not prior to chemotherapy. - At least 60 days must have elapsed between the last chemotherapy infusion and completion of the first baseline questionnaire. - Mean baseline fatigue as measured by the Brief Fatigue Inventory must be four or above. Exclusion Criteria: - Anemia, defined as Hb<9 or active treatment for anemia. Iron supplementation is allowed as long as the dose has been stable for at least six weeks. - Platelets less than 50,000/microliter or an Absolute Neutrophil Count less than 1,000/microliter. - Baseline depression score on the Hospital Anxiety and Depression Scale of 11 or above, indicating clinical depression. - Thyroid disorder, defined as either thyroid stimulating hormone or free T4 out of normal range, is excluded as it is a possible cause of fatigue unrelated to cancer therapy. - Surgery under general anesthesia; immunotherapy; radiotherapy; or initiation of hormonal therapy within the three weeks prior to enrollment. - Acupuncture in the previous six weeks. - Change in use of any of the following drugs in the prior three weeks: opiates, antidepressants (other than selective serotonin reuptake inhibitors [SSRIs])/anxiolytics; OR change in use of SSRIs in the prior six weeks. \"Change in use\" is defined as initiation or cessation of treatment, or change in prescribed dose or regimen: changes in actual amounts of PRN medication taken are allowed.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Procedure:AcupunctureSubjects 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.
Procedure:Placebo 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: April 2008
Completed Date: December 2011
Phase: Phase 3
Primary Outcome: To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively than placebo
Secondary Outcome: To examine the long term effects of acupuncture treatment on fatigue
Study sponsors, principal investigator, and references
Principal Investigator: Amy Matecki, MD
Lead Sponsor: Alta Bates Summit Medical Center