Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
43 participants
INTERVENTIONAL
2007-09-30
2009-07-31
Brief Summary
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The investigators performed a pilot randomized single-blinded controlled trial of acupressure in cancer survivors experiencing moderate to severe PCRF. Potential participants were excluded if they had other causes of fatigue such as anemia, malnutrition, or chronic fatigue syndrome. Participants were randomized to one of three treatment groups: 1. relaxation acupressure (RA), 2. high intensity stimulatory acupressure (HIS), and 3. low intensity stimulatory acupressure (LIS). Participants performed acupressure for 12 weeks between 3 to 14 times per week depending on group. Fatigue was measured with the Brief Fatigue Inventory (BFI). Secondary outcomes included beliefs and expectations, assessment of blinding, compliance to treatment, demographics, and clinical parameters. The effect of group on BFI was assessed with ANOVA and linear regression. Correlations were also made between compliance and change in BFI.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Relaxation acupressure
Self-administered Acupressure
High Intensity Stimulating Acupressure
Self-administered Acupressure
Low Intensity Stimulating Acupressure
Self-administered Acupressure
Interventions
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Self-administered Acupressure
Eligibility Criteria
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Inclusion Criteria
* A diagnosis of cancer, except for squamous and basal cell carcinomas, who had completed their cancer-related treatments at least 12 weeks prior (except for on-going hormone therapy, which must have been initiated at least three weeks prior to enrollment
* To have a complaint of persistent, moderate to severe fatigue despite standard treatment \[defined as \> 4 on the Brief Fatigue Inventory (BFI)\]
* To maintain their typical dietary patterns, especially the use of caffeinated beverages throughout the study,
* To be disease free and be acupuncture and acupressure naïve
Exclusion Criteria
* Have any comorbidities likely to cause significant fatigue (i.e., moderate to severe heart failure, hypothyroidism) either currently or before cancer diagnosis
* Have problems with easy or spontaneous bruising from any cause, e.g. bleeding disorders
* Have nutritional deficiencies \[defined by albumin levels \< 35 g/liter\]
* Have a diagnosis of depression and are not receiving active successful treatment for depression or have a HADS depression score of ≥ 11had a diagnosis of depression and are not receiving active successful treatment for depression or have a HADS depression score of ≥ 11
* Have a thyroid disorder, defined as either thyroid stimulating hormone or free T4 lower than the normal range or greater than 2xs the upper range
* Have an anticipated survival rate of less than 6 months
* Have an initiation, a cessation or change of dose (up to three weeks prior to the study's start) of any chronic medications or dietary supplements or any planned change of chronic medications or dietary supplements during the study
* and are pregnant or lactating
18 Years
ALL
No
Sponsors
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University of Michigan Rogel Cancer Center
OTHER
University of Michigan
OTHER
Responsible Party
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Suzanna Zick
Research Associate Professor
Locations
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University of Michigan Health System
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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10915
Identifier Type: -
Identifier Source: org_study_id
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