Fatigue Clinical Trial
Official title:
Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue: a Randomized Phase III Trial
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 64 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Alta Bates Summit Comprehensive Cancer Center | Berkeley | California |
Lead Sponsor | Collaborator |
---|---|
Alta Bates Summit Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively than placebo | six weeks | No | |
Secondary | To examine the long term effects of acupuncture treatment on fatigue | six months | No | |
Secondary | To examine predictors of response to acupuncture treatment in terms of baseline symptoms, hemoglobin, age, sex, time since chemotherapy, and concurrent treatment | six months | No | |
Secondary | To examine the effect of acupuncture on levels of physical activity and quality of life | six months | No |
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