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Acupressure for Post-Treatment Cancer Fatigue

Primary Purpose

Fatigue

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Self-administered Acupressure
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue focused on measuring Persistent Cancer-Related Fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Michigan Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Relaxation acupressure

High Intensity Stimulating Acupressure

Low Intensity Stimulating Acupressure

Arm Description

Outcomes

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

Secondary Outcome Measures

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

Full Information

First Posted
August 14, 2009
Last Updated
June 22, 2012
Sponsor
University of Michigan
Collaborators
University of Michigan Rogel Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00959998
Brief Title
Acupressure for Post-Treatment Cancer Fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
University of Michigan Rogel Cancer Center

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue
Keywords
Persistent Cancer-Related Fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Relaxation acupressure
Arm Type
Active Comparator
Arm Title
High Intensity Stimulating Acupressure
Arm Type
Experimental
Arm Title
Low Intensity Stimulating Acupressure
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Self-administered Acupressure
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Secondary objects were to evaluate the safety, tolerability, adherence, blinding and beliefs/expectation of participants of the three acupressure treatments

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States

12. IPD Sharing Statement

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Acupressure for Post-Treatment Cancer Fatigue

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