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RecruitingNot ApplicableNCT05725265

LLLT for BCRL: a Randomized, Placebo-controlled Study

Large-area Low-level Laser Therapy for Breast Cancer-related Lymphedema: a Randomized, Placebo-controlled Study

Sponsor

National Taiwan University Hospital

Enrollment

54 participants

Start Date

Oct 24, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Lymphedema

Summary

This study is conducted to compare between efficacy of large and small area of low-level laser therapy (LLLT) in treatment of post mastectomy lymphedema. The change of severity of BCRL will be measured by the difference of circumference and skin thickness, detected by ultrasound. The influence on clinical symptoms, such as pain, shoulder mobility and hand function, are also investigated in the study.

Eligibility

Sex: FEMALEMin Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether low-level laser therapy (a gentle, painless light treatment) can reduce arm swelling (lymphedema) in women who developed it after breast cancer treatment, including surgery or lymph node removal. **You may be eligible if...** - You are a woman, 20 years or older - You had breast cancer treated with lumpectomy or mastectomy plus lymph node removal - You have Stage I or II lymphedema (mild to moderate swelling) in one arm **You may NOT be eligible if...** - You have active or recurrent cancer - You have an infection or open wound in the affected arm - You are pregnant - Your lymphedema is severe (Stage III) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICELarge-area low-level laser therapy(Venusure)

The wavelength was 980±15nm, average dose was 10-40nm/cm2 and maximal output was 1000mW. Total treatment duration was 30 min and frequency was 3 sessions/week for 4 weeks; for a total of 12 sessions

DEVICEConventional low-level laser therapy

The wavelength was 808 nm and maximal output was 60 mW. Total treatment duration was 30 min and frequency was 3 sessions/week for 4 weeks; for a total of 12 sessions.

Locations(1)

National Taiwan University Hospital

Taipei, Taiwan

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NCT05725265

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