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NCT01281904 · ClinicalTrials.gov registry record · Phase 2
Acupressure for Persistent Cancer Related Fatigue
A Phase 2 study of Breast Cancer and Sleepiness, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 2
- Development phase
- 288
- Enrollment target
- 1
- Study location
NCT01281904: Completed Phase 2 study of Breast Cancer and Sleepiness, sponsored by University of Michigan.
NCT01281904 is a Phase 2 study of Breast Cancer and Sleepiness that has completed, run by University of Michigan. The registered enrollment target is 288 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01281904, a Phase 2 study of Breast Cancer and Sleepiness, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 288 participants
- Enrollment target
- 1
- Study location
Study 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 d
Conditions Studied
Interventions
- BEHAVIORAL Relaxation Acupressure
- BEHAVIORAL Stimulating Acupressure
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 288 participants |
| Start Date | 2011-04 |
| Est. Completion | 2014-09 |
| Phase | Phase 2 |
What the finished NCT01281904 record still lists
NCT01281904 is an interventional study that assigns participants to a tested intervention. The registered 288 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (90% lower).
The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Relaxation Acupressure is the first listed.
NCT01281904 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT01281904 about?
NCT01281904 is a clinical study titled "Acupressure for Persistent Cancer Related Fatigue". 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 th...
What is the current status of trial NCT01281904?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 288 participants. The study started on 2011-04. Estimated completion is 2014-09.
What conditions does trial NCT01281904 study?
This clinical trial studies the following conditions: Breast Cancer, Sleepiness, Chronic Fatigue.
What interventions are being tested in trial NCT01281904?
The interventions under investigation include: Relaxation Acupressure (BEHAVIORAL), Stimulating Acupressure (BEHAVIORAL).
Who is sponsoring clinical trial NCT01281904?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01281904 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01281904's enrollment target sits among peer trials
288 291st of 1224 higher than 934 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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