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CompletedNCT00959998Updated Jun 26, 2012

Acupressure for Post-Treatment Cancer Fatigue

A Phase 2 interventional study of Self-administered Acupressure in Fatigue, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-26.

Sponsored by University of Michigan · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Persistent cancer related fatigue (PCRF) is a common symptom experienced by many cancer survivors, which may last for as long as 10 years following treatment. PCRF is currently under diagnosed, with between 20% to >60% of survivors experiencing this symptom. Currently there are few effective treatment options for these patients. Acupressure offers a potential low-toxicity self-administered treatment option to treat PCRF.

The investigators performed a pilot randomized single-blinded controlled trial of acupressure in cancer survivors experiencing moderate to severe PCRF. Potential participants were excluded if they had other causes of fatigue such as anemia, malnutrition, or chronic fatigue syndrome. Participants were randomized to one of three treatment groups: 1. relaxation acupressure (RA), 2. high intensity stimulatory acupressure (HIS), and 3. low intensity stimulatory acupressure (LIS). Participants performed acupressure for 12 weeks between 3 to 14 times per week depending on group. Fatigue was measured with the Brief Fatigue Inventory (BFI). Secondary outcomes included beliefs and expectations, assessment of blinding, compliance to treatment, demographics, and clinical parameters. The effect of group on BFI was assessed with ANOVA and linear regression. Correlations were also made between compliance and change in BFI.

02

Conditions studied

  • Fatigue

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Keywords

  • Persistent Cancer-Related Fatigue
03

In context

Fatigue

1,912 studies on the registry are indexed under Fatigue; 381 are open to participants now.

This study's enrollment of 43 is below the median of 53 across 1,479 interventional studies indexed under Fatigue.

Browse Fatigue studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,503 studies on the registry; 189 are open to participants now.

Of its 167 completed or terminated interventional studies of FDA-regulated products, 132 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
43 participants (actual)

Study arms

  • Active comparator
    Relaxation acupressure

    Other: Self-administered Acupressure

  • Experimental
    High Intensity Stimulating Acupressure

    Other: Self-administered Acupressure

  • Experimental
    Low Intensity Stimulating Acupressure

    Other: Self-administered Acupressure

Interventions

  • OtherSelf-administered Acupressure
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What researchers measure

Primary outcomes

  1. 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

    Time frame: Once per week for 13 weeks

Secondary outcomes

  1. Secondary objects were to evaluate the safety, tolerability, adherence, blinding and beliefs/expectation of participants of the three acupressure treatments

07

Study locations

1 site
  • University of Michigan Health System
    Ann Arbor, Michigan 48104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00959998
Responsible party
Suzanna Zick (Research Associate Professor, University of Michigan) — Principal investigator
First posted
Aug 17, 2009
Start date
Sep 2007
Primary completion
Jul 2009
Completion
Jul 2009
Last update
Jun 26, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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