Acupressure for Post-Treatment Cancer Fatigue

Sponsor

University of Michigan (Other)

Overall Status

Completed

CT.gov ID

NCT00959998

Collaborator

University of Michigan Rogel Cancer Center (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

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

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

Outcome Measures

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 [Once per week for 13 weeks]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan Health System	Ann Arbor	Michigan	United States	48104

Sponsors and Collaborators

University of Michigan
University of Michigan Rogel Cancer Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Suzanna Zick, Research Associate Professor, University of Michigan

ClinicalTrials.gov Identifier:

NCT00959998

Other Study ID Numbers:

10915

First Posted:

Aug 17, 2009

Last Update Posted:

Jun 26, 2012

Last Verified:

Jun 1, 2012

Keywords provided by Suzanna Zick, Research Associate Professor, University of Michigan

Persistent Cancer-Related Fatigue

Additional relevant MeSH terms:

Fatigue

Study Results

No Results Posted as of Jun 26, 2012