Status:
UNKNOWN
Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue
Lead Sponsor:
Alta Bates Summit Medical Center
Conditions:
Fatigue
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
Brief Summary
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 acu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00658034
Start Date
April 1 2008
End Date
December 1 2011
Last Update
October 26 2011
Active Locations (1)
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1
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States, 94704