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


Phase 3
18 Years
64 Years
Not Enrolling
Both
Cancer

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Outcome Measure:

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

Outcome Time Frame:

six weeks

Safety Issue:

No

Principal Investigator

Gary Deng, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

04-081

NCT ID:

NCT00200096

Start Date:

July 2004

Completion Date:

February 2011

Related Keywords:

  • Cancer
  • Cancer
  • Fatigue
  • Fatigue

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Memorial Sloan-Kettering Cancer CenterBasking Ridge, New Jersey