Acupressure for Post-Treatment Cancer Fatigue

NCT00959998 | Completed Phase 2

• 1 other identifier: 10915
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fatigue

Keywords

Persistent Cancer-Related Fatigue

Outcome Measures

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

  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

Study Arms (3)

Relaxation acupressure

ACTIVE COMPARATOR

Other: Self-administered Acupressure

High Intensity Stimulating Acupressure

EXPERIMENTAL

Other: Self-administered Acupressure

Low Intensity Stimulating Acupressure

EXPERIMENTAL

Other: Self-administered Acupressure

Interventions

Self-administered Acupressure OTHER

High Intensity Stimulating Acupressure; Low Intensity Stimulating Acupressure; Relaxation acupressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• University of Michigan Rogel Cancer Center: collaborator

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48104, United States

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: August 14, 2009
• First Posted: August 17, 2009
• Study Start: September 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: June 26, 2012

Record last verified: 2012-06

Locations

US (1)