Clinical trial NCT00658034: Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue
Official title: Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue: a Randomized Phase III Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Fatigue
Keywords: Cancer
Fatigue
Acupuncture
Lead sponsor: Alta Bates Summit Medical Center
Sponsor class: OTHER
First posted: 2008-04-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively than placebo
timeFrame: six weeks
Secondary outcomes:
measure: To examine the long term effects of acupuncture treatment on fatigue
timeFrame: six months
measure: To examine predictors of response to acupuncture treatment in terms of baseline symptoms, hemoglobin, age, sex, time since chemotherapy, and concurrent treatment
timeFrame: six months
measure: To examine the effect of acupuncture on levels of physical activity and quality of life
timeFrame: six months
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Alta Bates Summit Comprehensive Cancer Center
state: California
Study officials:
affiliation: Alta Bates Summit Comprehensive Cancer Center
name: Amy Matecki, MD
role: PRINCIPAL_INVESTIGATOR
References: