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Acupressure for Persistent Cancer-Related Fatigue in Breast Cancer Survivors


Phase 2/Phase 3
18 Years
75 Years
Open (Enrolling)
Female
Chronic Fatigue, Breast Cancer, Sleepiness

Thank you

Trial Information

Acupressure for Persistent Cancer-Related Fatigue in Breast Cancer Survivors


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

The effect of 6-weeks of Relaxation Acupressure compared to a regime of Stimulating Acupressure or standard of care on fatigue.

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Suzanna M Zick, ND, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan

Authority:

United States: Federal Government

Study ID:

CA151445

NCT ID:

NCT01281904

Start Date:

April 2011

Completion Date:

December 2014

Related Keywords:

  • Chronic Fatigue
  • Breast Cancer
  • Sleepiness
  • Breast Neoplasms
  • Fatigue

Name

Location

University of Michigan Ann Arbor, Michigan  48109-0624