Acupressure for Persistent Cancer Related Fatigue
AcuCrft
2 other identifiers
interventional
288
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2011
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2011
CompletedFirst Posted
Study publicly available on registry
January 24, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedAugust 6, 2015
August 1, 2015
3.4 years
January 20, 2011
August 5, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
The effect of 6-weeks of Relaxation Acupressure compared to a regime of Stimulating Acupressure or standard of care on fatigue.
12 weeks
Secondary Outcomes (2)
The effect of 6-weeks of Relaxation Acupressure compared to a regime of Stimulating Acupressure or standard of care on sleep quality
12 weeks
Onset and duration of acupressure effect.
12 weeks
Study Arms (3)
Standard of Care
NO INTERVENTIONParticipants 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.
Relaxation Acupressure
ACTIVE COMPARATORIn 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.
Stimulating Acupressure
ACTIVE COMPARATORIn 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48106, United States
Related Publications (2)
Zick SM, Wyatt GK, Murphy SL, Arnedt JT, Sen A, Harris RE. Acupressure for persistent cancer-related fatigue in breast cancer survivors (AcuCrft): a study protocol for a randomized controlled trial. BMC Complement Altern Med. 2012 Aug 21;12:132. doi: 10.1186/1472-6882-12-132.
PMID: 22909076BACKGROUNDZick SM, Sen A, Wyatt GK, Murphy SL, Arnedt JT, Harris RE. Investigation of 2 Types of Self-administered Acupressure for Persistent Cancer-Related Fatigue in Breast Cancer Survivors: A Randomized Clinical Trial. JAMA Oncol. 2016 Nov 1;2(11):1470-1476. doi: 10.1001/jamaoncol.2016.1867.
PMID: 27388752DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suzanna M Zick, ND, MPH
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Associate Professor
Study Record Dates
First Submitted
January 20, 2011
First Posted
January 24, 2011
Study Start
April 1, 2011
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
August 6, 2015
Record last verified: 2015-08