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Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue: A Randomized, Phase III Trial

This study is currently recruiting participants.
Information provided by Memorial Sloan-Kettering Cancer Center

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Descriptive Information Fields
Brief Title  Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue: A Randomized, Phase III Trial
Official Title  Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue: A Randomized, Phase III Trial
Brief Summary

In a previous study, we found that acupuncture may decrease fatigue. The aim of this study is to determine whether acupuncture is helpful in reducing fatigue in cancer patients treated with chemotherapy. We will also study how fatigue, quality of life, mood, level of physical activity. This study will involve about 88 patients.

Detailed Description

Primary objective:

To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively than placebo

Secondary objectives:

  1. To examine the long-term effects of acupuncture treatment on fatigue
  2. To examine predictors of response to acupuncture treatment in terms of baseline symptoms, hemoglobin, age, sex, time since chemotherapy and concurrent treatment
  3. To examine the effect of acupuncture on levels of physical activity and quality of life.
Study Phase Phase III
Study Type  Interventional
Study Design  Other, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively than placebo [ Time Frame: six weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measure  To examine the long-term effects of acupuncture treatment on fatigue [ Time Frame: six months ] [ Designated as safety issue: No ]
To examine predictors of response to acupuncture treatment in terms of baseline symptoms, hemoglobin, age, sex, time since chemotherapy and concurrent treatment [ Time Frame: six months ] [ Designated as safety issue: No ]
To examine the effect of acupuncture on levels of physical activity and quality of life. [ Time Frame: six months ] [ Designated as safety issue: No ]
Condition  Cancer
Intervention  Procedure: Acupuncture and questionnaires
Procedure: placebo acupuncture
MEDLINE PMIDs
Links Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  88
Start Date  July 2004
Completion Date July 2009
Eligibility Criteria 

Inclusion Criteria:

  • Patients age 18 - 64 diagnosed with a malignancy (solid tumor or hematologic malignancy). We are excluding children primarily because fatigue in children is assessed differently from adults (56). Moreover, as children constitute only about 5% of the cancer population and as post-chemotherapy fatigue appears to be relatively rare in children (57), we would expect little if any accrual from the pediatric population. Patients aged 65 and over are excluded for likely non-response, as described under preliminary data.
  • Patients must have received chemotherapy
  • Patients must complain of fatigue following chemotherapy but not prior to chemotherapy
  • At least 60 days must have elapsed between the last chemotherapy infusion and completion of the first baseline questionnaire. Acute chemotherapy related fatigue typically lasts two to three weeks at most (58). Patients with fatigue at 60 days can therefore be considered to be chronic cases.
  • Mean baseline fatigue as measured by the Brief Fatigue Inventory (BFI) must be four or above. A score of four on the BFI is considered the threshold between "mild" and "moderate" symptoms (18).

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. Anemia is excluded as a major treatable cause of fatigue.
  • Platelets less than 50,000/microliter or an Absolute Neutrophil Count less than 1,000/microliter. Patients with low platelets or neutrophils are at the risk of bleeding or infection, respectively.
  • Baseline depression score on the Hospital Anxiety and Depression Scale of 11 or above, indicating clinical depression. Patients excluded for depression will be referred for appropriate psychiatric evaluation. Depression is excluded as a treatable cause of fatigue.
  • 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, anti-depressants (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.
Gender Both
Ages 18 Years to 64 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Gary Deng, MD, PhD     212-639-4956     Dengg@mskcc.org    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00200096
Organization ID 04-081
Secondary IDs ††
Study Sponsor  Memorial Sloan-Kettering Cancer Center
Collaborators ††
Investigators 
Principal Investigator:     Gary Deng, MD, PhD     Memorial Sloan-Kettering Cancer Center    
Information Provided By Memorial Sloan-Kettering Cancer Center
Verification Date June 2008
First Received Date  September 9, 2005
Last Updated Date June 17, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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