Acupressure for Post-Treatment Cancer Fatigue - Full Text View

Sponsor:	University of Michigan
Collaborator:	University of Michigan Cancer Center
Information provided by:	University of Michigan
ClinicalTrials.gov Identifier:	NCT00959998

Purpose

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	Intervention	Phase
Fatigue	Other: Self-administered Acupressure	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer Fatigue

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary objects were to evaluate the safety, tolerability, adherence, blinding and beliefs/expectation of participants of the three acupressure treatments [ Designated as safety issue: Yes ]

Enrollment:	43
Study Start Date:	September 2007
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959998

Locations

United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48104

Sponsors and Collaborators

University of Michigan

University of Michigan Cancer Center

More Information

No publications provided

Responsible Party:	Suzanna M. Zick, University of Michigan
ClinicalTrials.gov Identifier:	NCT00959998 History of Changes
Other Study ID Numbers:	10915
Study First Received:	August 14, 2009
Last Updated:	August 14, 2009
Health Authority:	United States: Federal Government

Keywords provided by University of Michigan:

Persistent Cancer-Related Fatigue

Additional relevant MeSH terms:

Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2012