Clinical trial · Interventional
Responsiveness of Outcome Scales in Breast Cancer Related Lymphedema
Investigation and Comparison of Lymphedema Outcome Measurements Validated in Turkish for Assessment of Breast Cancer Related Lymphedema
NCT04138667CI-TRIAL-00041287unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The aim of this study is to investigate and compare responsiveness of current lymphedema assessment scales validated in Turkish.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphedema of Upper Arm | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| complex decongestive therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with post-mastectomy lymphedema
- description
- Patients with breast cancer related lymphedema who will undergo complex decongestive therapy
- interventionNames
- Other: complex decongestive therapy
Primary outcomes (2)
- measure
- Limb volume measurement
- timeFrame
- before treatment (T0)
- description
- Limb volume will be calculated based on truncated cone method from circumference measurements
- measure
- Limb volume measurement
- timeFrame
- after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
- description
- Limb volume will be calculated based on truncated cone method from circumference measurements
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: -Patients with unilateral postmastectomy lymphedema with a International Society of Lymphology-ISL) stage 2 and 3 Exclusion Criteria: * Bilateral lymphedema * The patients who had known systemic edematogenic conditions (e.g., cardiac/hepatic/renal failure, terminal cancer, on chemotherapy), and/or with cancer recurrence * Patients with contraindications for application of complex decongestive therapy (active cutaneous infection, deep vein thrombosis, cardiac edema, and peripheral artery disease)
References
Publications (6)
- RESULTMenz HB, Auhl M, Tan JM, Levinger P, Roddy E, Munteanu SE. Comparative Responsiveness of Outcome Measures for the Assessment of Pain and Function in Osteoarthritis of the First Metatarsophalangeal Joint. Arthritis Care Res (Hoboken). 2020 May;72(5):679-684. doi: 10.1002/acr.23883. Epub 2020 Apr 8. PMID 30908853
- RESULTBorman P, Yaman A, Denizli M, Karahan S, Ozdemir O. The reliability and validity of Lymphedema Quality of Life Questionnaire-Arm in Turkish patients with upper limb lymphedema related with breast cancer. Turk J Phys Med Rehabil. 2018 Jul 9;64(3):205-212. doi: 10.5606/tftrd.2018.2843. eCollection 2018 Sep. PMID 31453513
- RESULTDuygu E, Bakar Y, Keser I. An Important Tool in Lymphedema Management: Validation of Turkish Version of the Patient Benefit Index-Lymphedema. Lymphat Res Biol. 2020 Feb;18(1):49-55. doi: 10.1089/lrb.2018.0036. Epub 2019 May 30. PMID 31145018
- RESULTBakar Y, Tugral A. Translation, reliability, and validation of the Turkish version of the Lymphedema Quality-of-Life tool in Turkish-speaking patients with lower limb Lymphedema. J Vasc Nurs. 2019 Mar;37(1):11-17. doi: 10.1016/j.jvn.2018.11.005. Epub 2019 Jan 31. PMID 30954192
- RESULTBakar Y, Tugral A, Ozdemir O, Duygu E, Uyeturk U. Translation and Validation of the Turkish Version of Lymphedema Quality of Life Tool (LYMQOL) in Patients with Breast Cancer Related Lymphedema. Eur J Breast Health. 2017 Jul 1;13(3):123-128. doi: 10.5152/ejbh.2017.3522. eCollection 2017 Jul. PMID 28894851
- RESULTKostanoglu A, Hosbay Z, Tarakci E. Lymphoedema functioning, disability and health questionnaire Turkish version: translation, cross-cultural adaptation and validation. J Phys Ther Sci. 2016 Jun;28(6):1728-32. doi: 10.1589/jpts.28.1728. Epub 2016 Jun 28. PMID 27390404