Breast Cancer Clinical Trial
— AcuCrftOfficial title:
Acupressure for Persistent Cancer-Related Fatigue in Breast Cancer Survivors
Verified date | August 2015 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 288 |
Est. completion date | September 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | National Cancer Institute (NCI) |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The effect of 6-weeks of Relaxation Acupressure compared to a regime of Stimulating Acupressure or standard of care on fatigue. | 12 weeks | No | |
Secondary | The effect of 6-weeks of Relaxation Acupressure compared to a regime of Stimulating Acupressure or standard of care on sleep quality | 12 weeks | No | |
Secondary | Onset and duration of acupressure effect. | 12 weeks | No |
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