Clinical trial · Interventional
LLLT Combined With CDT in Breast Cancer-Related Lymphedema
The Effectiveness of Low Level Laser Therapy (LLLT)Combined With Complex Decongestive Therapy (CDT) in the Treatment of Breast Cancer-Related Lymphedema: A Double-Blind, Randomized, Placebo-Controlled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to explore the effects of Low Level Laser Therapy (LLLT) on breast cancer-related lymphedema when utilized in conjunction with Complex Decongestive Therapy (CDT) when compared to CDT treatment alone. The investigators hypothesize that the addition of LLLT to CDT will result in statistically significant improvements and greater long-term benefits as measured by changes in arm volume and quality of life when compared to the benefits of CDT alone for the treatment of breast cancer-related lymphedema.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low Level Laser | Device | — | UNRESOLVED |
| Low Level Laser Therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- CDT + inactive LLL
- interventionNames
- Device: Low Level Laser Therapy
- type
- ACTIVE_COMPARATOR
- label
- LLL combined with CDT
- description
- CDT + active LLL
- interventionNames
- Device: Low Level Laser
Primary outcomes (1)
- measure
- Arm Volume
- timeFrame
- 13 Months
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * unilateral breast cancer with ipsilateral lumpectomy or mastectomy and lymph node dissection (sentinel biopsy or axillary dissection) * stage II or III unilateral secondary upper extremity lymphedema (as defined by the International Society of Lymphology) * girth ≥ 2 cm circumferential difference and/or volume ≥ 200 mL compared to the uninvolved upper extremity at any 4 cm segment * able to commit to a long term follow-up schedule Exclusion Criteria: * active cancer/metastatic cancer * currently receiving or have plans for adjuvant radiation or chemotherapy * pregnant * presence of other extremity lymphedema (primary or secondary) * pacemaker * artificial joints in the upper quadrants * renal failure * arterial insufficiency * congestive heart failure * chronic inflammatory conditions * history of deep vein thrombosis (DVT) in the lymphedematous upper extremity * previous treatment with Low Level Laser (regardless of indication) * medication(s) known to affect body fluid balance * body mass index (BMI) \> 40 (morbid obesity)
References
Publications (0)
Data not yet available