Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue

Status unconfirmed · Phase 3 · Has a placebo group

Conditions studied: Fatigue

In brief

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.

Key facts

Study ID

NCT00658034

Run by

Alta Bates Summit Medical Center

People needed

20

Starts

2008-04-01

Expected to finish

2011-12-01

Last updated by the study team

2011-10-26

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Alta Bates Summit Comprehensive Cancer Center — Berkeley, California, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.