Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue

Study Overview
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Brief Summary
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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.

Official Title
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Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue: a Randomized Phase III Trial

Conditions
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Fatigue

Intervention / Treatment
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* Procedure: Acupuncture
* Procedure: Placebo Acupuncture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Acupuncture | Procedure: Acupuncture<br>* Subjects will receive acupuncture weekly for six weeks. Subjects will complete a Brief Fatigue Inventory (BFI) questionnaire, a Functional Assessment of Cancer Treatment scale (FACT-G), and a Hospital Anxiety and Depression Scale(HADS) at week 7. The BFI and FACT-G will be repeated at week 8. At the end of the study, subjects will be asked to state whether they thought they were on true or placebo acupuncture and why.<br>|
| Sham Comparator: 2<br>Placebo Acupuncture | Procedure: Placebo Acupuncture<br>* Subjects will receive placebo acupuncture weekly for six weeks. During the placebo phase, placebo acupuncture needles will be applied a few mm away from the required points. The placebo acupuncture needle is a blunt tipped needle that moves up inside its handle. When it is pressed against the skin, the subject feels a slight prick and sees the handle of the needle moving towards the skin as if the needle has been inserted. Subjects will complete a BFI, a FACT-G, and a HADS at week 7. The BFI and FACT-G will be repeated at week 8. At the end of the study, subjects will be asked to state whether they thought they were on true or placebo acupuncture and why. Subjects in the placebo group will be given the option to receive true acupuncture.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively than placebo |  | six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Fatigue, Acupuncture