Acupressure for Persistent Cancer Related Fatigue (AcuCrft)

August 5, 2015 updated by: Suzanna Zick, University of Michigan

Acupressure for Persistent Cancer-Related Fatigue in Breast Cancer Survivors

There are over 2 million breast cancer survivors today. Persistent Cancer-Related fatigue (PCRF), a state of being tired or weary, is one of the most common and distressing symptoms experienced by breast cancer (BC) survivors. Rates of significant PCRF in BC survivors range from 30% to 82% within the first 5-years of diagnosis and there are few treatment options for PCRF and these treatments require the availability of a trained practitioner, are associated with significant costs, pose a sizeable burden for the patient, or have unacceptable side-effects.

Acupressure is a technique derived from acupuncture, a component of Traditional Chinese Medicine. In acupressure, physical pressure is applied to acupuncture points by the hand, elbow, or with various devices to treat disease. Pilot studies have demonstrated that self-administered acupressure can significantly decrease PCRF by as much as 70% in cancer survivors. Acupressure can also have positive effects on sleep quality in cancer patients and other chronically ill populations. Self-administered acupressure is a non-toxic and inexpensive treatment that requires minimal instruction. It also requires little effort and time on the part of the patient to successfully complete. Thus, acupressure appears to be a promising treatment for PCRF and associated symptoms.

The investigators are conducting a single-blind, placebo controlled study to examine the specific effect of two opposing acupressure treatments compared to standard of care. The goal of this study is to determine the benefit of acupressure on treating persistent fatigue experience by many patients after completing their cancer treatment. Study patients will be randomized into one of three groups: two different types of acupressure or a standard of care arm. For those participants randomized to receive acupressure, the technique will be taught to them by a study nurse trained by an acupressure specialist. Participants will be asked to perform the acupressure daily over the next six weeks, during which time they will record their fatigue and be asked to wear an activity monitor to have their daily activity levels monitored.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

288

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 18 years of age or older
  • Diagnosis of breast cancer
  • Have completed all cancer related treatments (i.e. surgery, chemotherapy, radiotherapy, immunotherapy, etc.) at least 1 year prior to enrollment except for hormone therapy which must have been initiated at least three weeks prior to enrollment
  • Apparently cancer-free
  • Able to self-administer acupressure
  • Have a complaint of persistent, moderate to severe fatigue despite standard treatment [defined as ≥ 4 on the Brief Fatigue Inventory (BFI)]
  • Able to maintain typical dietary (eating and drinking) patterns, especially the use of caffeinated beverages throughout the study
  • Willing to participate in an 11-week clinical trial that involves 5 study visits (not including the screening visit, as well as weekly phone calls

Exclusion Criteria:

  • Pregnant (per urine pregnancy test), wanting to become pregnant or Lactating
  • Diagnosis of anemia or receiving treatment for it
  • Have any comorbidities likely to cause significant fatigue (i.e., moderate to severe heart failure, hypothyroidism, chronic fatigue syndrome) either currently or before cancer diagnosis
  • Have a diagnosis of depression, receiving active treatment for depression, or have HADS score of ≥11
  • Currently taking medication for insomnia
  • Have an initiation, 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
  • Had acupuncture or acupressure within the last 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care
Participants randomized into the standard of care group will be asked to continue following the instructions of the healthcare provider throughout the 10 week study period. They will not be asked to perform any study intervention.
Active Comparator: Relaxation Acupressure
In addition to their standard of care, participants will be asked to apply pressure on each of 9 acupressure points (bilaterally where indicated) that have been carefully selected for their relaxing effect. (There are 5 acupoints with 4 of the acupoints performed on both the left and the right sides of the body giving a total of 9 points to stimulate. Each of the 9 acupoints will be stimulated for 3 minutes per point giving a total treatment time of 27 minutes done once daily over a period of 6 weeks followed by 4 weeks of intervention wash-out where the participant will be asked to perform no acupressure at all.
Behavioral: Relaxation Acupressure
Apply pressure on 9 relaxatory acupressure points for 3 minutes each once daily for a 6 week period, followed by a 4 week wash-out period.
Active Comparator: Stimulating Acupressure
In addition to their standard of care, participants will be asked to apply pressure on each of 9 acupressure points (bilaterally where indicated) that have been carefully selected for their excitatory effect. (There are 5 acupoints with 4 of the acupoints performed on both the left and the right sides of the body giving a total of 9 points to stimulate. There are 6 acupoints with 4 of the acupoints performed on both the left and the right sides of the body giving a total of 10 points to stimulate. Each of the 10 acupoints will be stimulated for 3 minutes per point giving a total treatment time of 30 minutes done once daily over a period of 6 weeks followed by 4 weeks of intervention wash-out where the participant will be asked to perform no acupressure at all.
Behavioral: Stimulating Acupressure
Apply pressure on 10 excitatory acupressure points for 3 minutes each once daily for a 6 week period, followed by a 4 week wash-out period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The effect of 6-weeks of Relaxation Acupressure compared to a regime of Stimulating Acupressure or standard of care on fatigue.
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The effect of 6-weeks of Relaxation Acupressure compared to a regime of Stimulating Acupressure or standard of care on sleep quality
Time Frame: 12 weeks
12 weeks
Onset and duration of acupressure effect.
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

January 20, 2011

First Submitted That Met QC Criteria

January 20, 2011

First Posted (Estimate)

January 24, 2011

Study Record Updates

Last Update Posted (Estimate)

August 6, 2015

Last Update Submitted That Met QC Criteria

August 5, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA151445
  • R01CA151445 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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