Clinical trial · Interventional
Evaluation of the Treatment Response in Breast Cancer Related Lymphedema
Evaluation of the Treatment Response in Breast Cancer Related Lymphedema After Mastectomy Surgery
- 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 evaluate the effects of the treatment for breast cancer lymphedema. After taking a detailed history and giving a physical examination, breast cancer related lymphedema patients(n:30) will be informed and will be given Complete Decongestive Therapy, which includes decongestive exercises, manual lymphatic drainage, compression therapy(either through short stretch bandaging and/or pneumatic device) and exercise. Patients will be evaluated with limb volume, lymphedema index acquired through bioimpedance device, QuickDASH for upper extremity function, hand dynamometer for upper extremity grip strength and CLUE(Breast Cancer-Related Lymphedema of the Upper Extremity standardized clinical evaluation tool) scoring for lymphedema before and after the intervention. The values will be compared in order to show whether there are significant differences between before and after scores, and whether CLUE score is correlated with the other indicators of breast cancer related lymphedema.
Conditions
Conditions (3)
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 |
| Breast Cancer Lymphedema | — | UNRESOLVED | — |
| Lymphedema of Upper Limb | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Complete Decongtestive Therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Complete Deongestive Therapy
- description
- Patients will be given complete decongestive therapy for 5 days a week and for a mean of 20 sessions. Each session will be of approximately 2 hours and 15 minutes in duration, although short stretch bandaging will be left on for 23 hours a day.
- interventionNames
- Procedure: Complete Decongtestive Therapy
Primary outcomes (1)
- measure
- CLUE score
- timeFrame
- 1 month
- description
- Breast Cancer-Related Lymphedema of the Upper Extremity (CLUE) is a standardized clinical evaluation tool which was developed to evaluate the severity of the lymphedema, especially in the context of clinical trials. CLUE involves assessing obscuration of anatomical architecture (eg, bony prominences, tendons), deviation from normal anatomical contour, change of soft-tissue texture, and the presence of pitting or nonpitting edema. It consists of these four assessments conducted in three different parts or the upper extremity(arm, forearm and hand). CLUE scores have a range of 0 to 72, with greater numbers associated with more severe lymphedema. It was shown to be valid and reliable for the assessment of breast cancer related lymphedema by Spinelli et al.(1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Unilateral lymphedema of the arm after mastectomy for breast cancer Exclusion Criteria: * Bilateral lymphedema * Primary bone tumor and/or metastasis * Patients with ongoing radiotherapy * Circulation disorders of the upper extremity(eg; peripheral vascular disease, thrombosis) * Patients with infectious lymphedema/elephantiasis * Presence of local infection in upper extremities(cellulitis) and/or presence of severe systemic infection * Carcinomatous lymphangitis * Congestive heart failure(NYHA class 3 or 4) * History of prosthesis on upper extremities * Use of drugs which may alter the fluid or electrolyte balance
References
Publications (1)
- RESULTSpinelli B, Kallan MJ, Zhang X, Cheville A, Troxel A, Cohn J, Dean L, Sturgeon K, Evangelista M, Zhang Z, Ebaugh D, Schmitz KH. Intra- and Interrater Reliability and Concurrent Validity of a New Tool for Assessment of Breast Cancer-Related Lymphedema of the Upper Extremity. Arch Phys Med Rehabil. 2019 Feb;100(2):315-326. doi: 10.1016/j.apmr.2018.08.185. Epub 2018 Oct 4. PMID 30291828