Clinical trial NCT00200096: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer
Keywords: Cancer
Fatigue
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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.

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: Basking Ridge
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Gary Deng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: