Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue

Phase 3

• Conditions: Fatigue
• Interventions: Procedure: Acupuncture; Procedure: Placebo Acupuncture

• Registration Number: NCT00658034
• Lead Sponsor: Alta Bates Summit Medical Center

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 acupuncture or placebo treatment as a means of evaluating whether acupuncture reduces chronic fatigue after chemotherapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-08
• Study First Submitted QC: 2008-04-08
• Study First Posted: 2008-04-14
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-25
• Last Update Posted: 2011-10-26
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Acupuncture	Acupuncture
2	Placebo Acupuncture	Placebo Acupuncture

Primary Outcome Measures

Name	Time	Method
To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively than placebo	six weeks

Secondary Outcome Measures

Name	Time	Method
To examine the long term effects of acupuncture treatment on fatigue	six months
To examine predictors of response to acupuncture treatment in terms of baseline symptoms, hemoglobin, age, sex, time since chemotherapy, and concurrent treatment	six months
To examine the effect of acupuncture on levels of physical activity and quality of life	six months

Trial Locations

Locations (1)

Alta Bates Summit Comprehensive Cancer Center; 🇺🇸 Berkeley, California, United States