Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue

Alta Bates Summit Medical Center

Status and phase

Unknown

Phase 3

Conditions

Fatigue

Treatments

Procedure: Acupuncture

Procedure: Placebo Acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT00658034

08-IM-01

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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.