Acupressure for managing symptoms in breast cancer survivors
Somatic Acupressure on Fatigue-sleep Disturbance-depression Symptom Cluster in Breast Cancer Survivors: a Phase III Randomised Controlled Trial
This study is testing if acupressure can help breast cancer survivors feel less tired, sleep better, and improve their mood compared to usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Charles Darwin University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Zunyi, Guizhou and 1 other locations) |
| Trial ID | NCT06412107 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial evaluates the effects, safety, and cost-effectiveness of somatic acupressure on the fatigue-sleep disturbance-depression symptom cluster in breast cancer survivors. The study aims to address the significant impact of these symptoms on quality of life, as current pharmacological options are limited and may pose risks. Participants will receive either true acupressure, sham acupressure, or usual care, with the goal of determining the effectiveness of this nonpharmacological intervention. The study follows the Medical Research Council Framework for developing complex interventions to ensure a robust evaluation.
Who should consider this trial
Good fit: Ideal candidates are early-stage female breast cancer survivors experiencing moderate to severe fatigue, sleep disturbances, and depression.
Not a fit: Patients currently using pharmaceutical treatments for fatigue, sleep disturbance, or depression may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life for breast cancer survivors by alleviating debilitating symptoms.
How similar studies have performed: While the effectiveness of somatic acupressure in this specific context remains uncertain, nonpharmacological interventions have shown promise in managing similar symptom clusters in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosed with early-stage female BC without distant metastases (from stage I to IIIa). 2. Have experienced at least moderate FSDSC with a score of ≥4 on an 0-10 point Numeric Rating Scale (0= 'no symptom',10= 'worst symptom') for fatigue, sleep disturbance and depression during the past month. 3. Had completed chemotherapy for at least one month and up to three years (to capture persistent symptoms) 4. Have no scheduled chemotherapy or radiotherapy during the study. 5. Be willing to participate in this study and consent in writing. Exclusion Criteria: 1. Currently using pharmaceutical drugs (e.g., antidepressant medications or hypnotics) to treat symptoms of fatigue, sleep disturbance, or depression. 2. Inability (or difficulty) in following the study procedures and instructions due to being extremely weak and/or cognitively impaired. 3. Received any type of somatic acupressure interventions during the past six months. 4. Currently involved in any other studies.
Where this trial is running
Zunyi, Guizhou and 1 other locations
- The Affiliated Hospital of Zunyi Medical University — Zunyi, Guizhou, China (Recruiting)
- The Second Affiliated Hospital of Zunyi Medical University — Zunyi, Guizhou, China (Recruiting)
Study contacts
- Principal investigator: Tao Wang, PhD — Charles Darwin University
- Study coordinator: Meng-Yuan Li, PhDc
- Email: mengyuanli@students.cdu.edu.au
- Phone: 0472 663736
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.