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A Comparison of Low-Level Laser Therapy at 2 and 4 J/cm2 in Breast Cancer-Related Lymphedema: A Randomized Controlled Trial

A Comparison of Low-Level Laser Therapy at 2 and 4 J/cm2 in Breast Cancer-Related Lymphedema: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260310002
Enrollment
34
Registered
2026-03-10
Start date
2026-05-15
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Breast cancer related lymphedema Breast cancer related lymphedema, low level laser therapy

Interventions

Low-Level Laser Therapy (LLLT) using the Mphi5 device with combined wavelengths of 808 nm and 905 nm in a continuous anti-edema mode at an energy density of 2 J/cm2, administered in 18 sessions over 6
therapeutic exercise to enhance the muscle pump mechanism
patient education regarding ergonomics, skin care, and precautions to optimize arm function
the use of compression garments to be worn for at least 23 hours per day
and a personalized self-management plan for lymphedema care at home.,Low-Level Laser Therapy (LLLT) using the Mphi5 device with combined wavelengths of 808 nm and 905 nm in a continuous anti-edema mod
the use of compression garments t
Experimental Device,Active Comparator Device,Sham Comparator Procedure/Surgery
Laser 2 J/cm2,Laser 4 J/cm2,Sham laser

Sponsors

Siriraj Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Female 2. Over 20 years old 3. Patients with unilateral breast cancer who have undergone mastectomy 4. Diagnosed with post-operative lymphedema, Stages 1 to 3, according to the International Society of Lymphology (ISL) criteria 5. Able to participate in the entire research process and attend follow-up appointments consistently 6. No previous history of Low-Level Laser Therapy (LLLT) 7. Able to receive treatment 3 times per week 8. Not currently receiving, or planning to receive, radiation therapy or chemotherapy until the completion of the study

Exclusion criteria

Exclusion criteria: 1. Metastasis: Patients with advanced or metastatic cancer 2. Presence of cognitive impairment (Thai Mental State Examination: TMSE < 23 points) 3. Presence of bilateral arm swelling (both sides) 4. Pregnancy 5. History of Deep Vein Thrombosis (DVT) in the upper extremities 6. Presence of abnormal bleeding disorders 7. Presence of open wounds or infections at the treatment site. 8. Dermatological Conditions: Contagious skin diseases (e.g., ringworm, shingles, or scabies) 9. History of bone fractures in the affected upper extremity 10. Presence of joint prostheses in the upper extremities 11. Presence of a cardiac pacemaker 12. Renal failure 13. Pulmonary edema 14. Obesity: Class II obesity or higher (BMI > 35 kg/m2) 15. Surgical History: Previous lymphatic bypass or lymphovenous anastomosis surgery in the affected arm 16. Currently undergoing chemotherapy or radiation therapy 17. Neurological Deficits: Presence of weakness or numbness (paresthesia) in either arm 18. Nerve Injury: History of brachial plexus or nerve injury in either arm

Design outcomes

Primary

MeasureTime frame
Arm volume Baseline, 3rd week, 6th week, 12th week, 6th month Calculated by 4 levels arm circumference

Secondary

MeasureTime frame
Pain scale Baseline, 3rd week, 6th week, 12th week, 6th month Visual analog scales,Quality of life Baseline, 6th week, 12th week, 6th month Thai Lymphoedema functioning disability and health questionnaire for upper limb lymphoedema,Grip strength Baseline, 3rd week, 6th week, 12th week, 6th month Digital hand grip dynamometer,Shoulder range of motion Baseline, 6th week, 12th week, 6th month Goniometer,Satisfaction 6th week Likert scales

Countries

Thailand

Contacts

Public ContactPiyapat Dajpratham

Department of Rehabilitation Medicine, Faculty of Medicine Siriraj Hospital

piyapat.daj@mahidol.ac.th0812590668

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026