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A Comparative Study of Treatment Approaches for Post-Breast Cancer Lymphedema in Geriatric: A Randomized Controlled trial study

Influence of adding local acupoints to systemic acupuncture on post-mastectomy lymphedema in geriatrics

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
PACTR
Registry ID
PACTR202504565606793
Enrollment
60
Registered
2025-04-30
Start date
2025-04-07
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Circulatory System Respiratory Surgery lymphedema Cardiology

Interventions

Group 1 Body Acupuncture as the primary treatment.
Group 2 Body Acupuncture along with Local Acupuncture

Sponsors

Alaa
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Inclusion Criteria:* 1. *Age:* Patients aged 60 and above (geriatrics). 2. *Diagnosis:* Diagnosed with post-mastectomy lymphedema, preferably after breast cancer treatment. 3. *Gender:* Female patients, since the study focuses on post-mastectomy lymphedema. 4. *Lymphedema Severity:* Mild to moderate lymphedema based on a standard clinical evaluation. 5. *Acupuncture Suitability:* No contraindications to acupuncture or moxibustion therapy. 6. *Consent:* Patients must give informed consent to participate in the study and commit to attending the scheduled sessions. 7. *Health Status:* Stable general health (no serious comorbidities such as heart disease, uncontrolled diabetes, etc.) to avoid confounding factors.

Exclusion criteria

Exclusion criteria: *Exclusion Criteria:* 1. *Severe Lymphedema:* Severe or advanced lymphedema that would not benefit from acupuncture. 2. *Active Cancer:* Patients currently undergoing cancer treatment (chemotherapy, radiation, etc.). 3. *Contraindications to Acupuncture:* Any condition where acupuncture or moxibustion is contraindicated (e.g., active infections, certain skin conditions, or bleeding disorders). 4. *Previous Treatments:* Patients with prior acupuncture or other alternative treatments for lymphedema are eligible if their condition has not significantly improved or if they are not currently receiving ongoing treatments. 5. *Cognitive Impairment:* Patients with cognitive dysfunction or mental health issues that would hinder their ability to participate in the study. 6. *Lymphatic Disorders:* Patients with primary lymphedema or other non-cancer-related lymphatic conditions. 7. *Medication Interference:* Patients on medications that significantly interfere with the immune system or wound healing, which could confound study results. 8. *Other Acute Conditions:* Patients with any acute or systemic illness (e.g., severe infections, fever) at the time of recruitment. 9. *Non-Compliance Risk:* Patients who may not be able to attend all study sessions or follow post-treatment instructions.

Design outcomes

Primary

MeasureTime frame
*Reduction in Lymphedema Volume: by tape measurement circumference - Measured by comparing the volume of the affected limb(s) before and after the treatment. This will be assessed using the *circumferential measurement* technique or *bioimpedance spectroscopy* to quantify changes in limb swelling.

Secondary

MeasureTime frame
1. *Pain Reduction:* - Measured using a *Visual Analog Scale (VAS)* or *Numeric Pain Rating Scale (NPRS)* to assess changes in pain levels before and after the treatment. 2. *Quality of Life Improvement:* - Assessed using a *Lymphedema Quality of Life (LYMQOL)* questionnaire or another relevant quality of life tool, which evaluates physical, emotional, and social well-being in patients with lymphedema. 3. *Patient Satisfaction with Treatment:* - Evaluated through a *Patient Satisfaction Questionnaire (PSQ)* or similar tool to gauge how the patient feels about the treatment's effectiveness and comfort level with acupuncture.

Countries

Egypt

Contacts

Public ContactAmir Nazih Wadee Mawad

Professor of physical therapy department of basic science and Dean of Pharos University

anazih@cu.edu.eg01222367919

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026