Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue

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.

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.