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Phase 2
18 Years
N/A
Not Enrolling
Both
Fatigue

Thank you

Trial Information


Inclusion Criteria:



- People aged 18 years of age and older

- A diagnosis of cancer, except for squamous and basal cell carcinomas, who had
completed their cancer-related treatments at least 12 weeks prior (except for
on-going hormone therapy, which must have been initiated at least three weeks prior
to enrollment

- To have a complaint of persistent, moderate to severe fatigue despite standard
treatment [defined as > 4 on the Brief Fatigue Inventory (BFI)]

- To maintain their typical dietary patterns, especially the use of caffeinated
beverages throughout the study,

- To be disease free and be acupuncture and acupressure naïve

Exclusion Criteria:

- Diagnosed with anemia [defined as hemoglobin levels < 12 gm/dl] or receiving
treatment for anemia

- Have any comorbidities likely to cause significant fatigue (i.e., moderate to severe
heart failure, hypothyroidism) either currently or before cancer diagnosis

- Have problems with easy or spontaneous bruising from any cause, e.g. bleeding
disorders

- Have nutritional deficiencies [defined by albumin levels < 35 g/liter]

- Have a diagnosis of depression and are not receiving active successful treatment for
depression or have a HADS depression score of ≥ 11had a diagnosis of depression and
are not receiving active successful treatment for depression or have a HADS
depression score of ≥ 11

- Have a thyroid disorder, defined as either thyroid stimulating hormone or free T4
lower than the normal range or greater than 2xs the upper range

- Have an anticipated survival rate of less than 6 months

- Have an initiation, a 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

- and are pregnant or lactating

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To examine the effect of two intensities of self-administered stimulating acupressure compared to self-administered relaxation acupressure on severity of chronic fatigue in people diagnosed with cancer who had completed all cancer therapies

Outcome Time Frame:

Once per week for 13 weeks

Safety Issue:

No

Authority:

United States: Federal Government

Study ID:

10915

NCT ID:

NCT00959998

Start Date:

September 2007

Completion Date:

July 2009

Related Keywords:

  • Fatigue
  • Persistent Cancer-Related Fatigue
  • Fatigue

Name

Location

University of Michigan Health System Ann Arbor, Michigan