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Acupressure for Post-Treatment Cancer Fatigue

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00959998
Recruitment Status : Completed
First Posted : August 17, 2009
Last Update Posted : June 26, 2012
University of Michigan Rogel Cancer Center
Information provided by (Responsible Party):
Suzanna Zick, University of Michigan

Brief Summary:

Persistent cancer related fatigue (PCRF) is a common symptom experienced by many cancer survivors, which may last for as long as 10 years following treatment. PCRF is currently under diagnosed, with between 20% to >60% of survivors experiencing this symptom. Currently there are few effective treatment options for these patients. Acupressure offers a potential low-toxicity self-administered treatment option to treat PCRF.

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.

Condition or disease Intervention/treatment Phase
Fatigue Other: Self-administered Acupressure Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arm Intervention/treatment
Active Comparator: Relaxation acupressure Other: Self-administered Acupressure
Experimental: High Intensity Stimulating Acupressure Other: Self-administered Acupressure
Experimental: Low Intensity Stimulating Acupressure Other: Self-administered Acupressure

Primary Outcome Measures :
  1. To examine the effect of two intensities of self-administered stimulating acupressure compared to self-administered relaxation acupressure on severity of chronic fatigue in people diagnosed with cancer who had completed all cancer therapies [ Time Frame: Once per week for 13 weeks ]

Secondary Outcome Measures :
  1. Secondary objects were to evaluate the safety, tolerability, adherence, blinding and beliefs/expectation of participants of the three acupressure treatments

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • People aged 18 years of age and older
  • 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:

  • Diagnosed with anemia [defined as hemoglobin levels < 12 gm/dl] or receiving treatment for anemia
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00959998

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United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48104
Sponsors and Collaborators
University of Michigan
University of Michigan Rogel Cancer Center

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Responsible Party: Suzanna Zick, Research Associate Professor, University of Michigan Identifier: NCT00959998     History of Changes
Other Study ID Numbers: 10915
First Posted: August 17, 2009    Key Record Dates
Last Update Posted: June 26, 2012
Last Verified: June 2012

Keywords provided by Suzanna Zick, University of Michigan:
Persistent Cancer-Related Fatigue

Additional relevant MeSH terms:
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Signs and Symptoms