Clinical trial NCT01281904: Acupressure for Persistent Cancer Related Fatigue
Official title: Acupressure for Persistent Cancer-Related Fatigue in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Fatigue
Breast Cancer
Sleepiness
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-01-24
Enrollment: 288
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The effect of 6-weeks of Relaxation Acupressure compared to a regime of Stimulating Acupressure or standard of care on fatigue.
timeFrame: 12 weeks
Secondary outcomes:
measure: The effect of 6-weeks of Relaxation Acupressure compared to a regime of Stimulating Acupressure or standard of care on sleep quality
timeFrame: 12 weeks
measure: Onset and duration of acupressure effect.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Suzanna M Zick, ND, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Zick 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.