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

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.