Clinical trial · Interventional
Effectiveness of Kinesio Taping in Patients With Chronic Breast and/or Truncal Oedema After Treatment for Breast Cancer.
Effectiveness of Kinesio Taping in Patients With Chronic Breast and/or Truncal Oedema After Breast Cancer Treatment: A Randomized Controlled Trial
- 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 goal of the KiTaLymph trial is to investigate whether the application of kinesio tape is effective in women with persistent (\>6 months) breast and/or truncal oedema after treatment for breast cancer. The main objectives are to assess whether kinesio taping: * reduces pain and symptoms, * decreases swelling, * improves quality of life (QoL). This study will compare a control group receiving standard care, decongestive lymphatic therapy (DLT), to an intervention group receiving DLT in combination with kinesio taping, in order to determine whether the addition of kinesio tape yields superior clinical outcomes. Participants will be randomly allocated to one of the two study arms. Both groups will participate in a 4-week intervention phase, consisting of two treatment sessions per week. This will be followed by a 6-month follow-up period to assess the durability of treatment effects and cost-related outcomes. A total of approximately 128 participants will be recruited. Outcome assessments will be conducted at baseline, immediately post-intervention (1 month), and at 3 and 6 months following the end of the intervention. These assessments will include standardised patient-reported outcome measures evaluating symptoms, quality of life, and pain, namely, the Breast Edema Questionnaire (BrEQ), the EORTC-QLQ-BR23, the EQ-5D-5L, and a visual analogue scale (VAS), as well as objective physical measurements of oedema using the LymphScanner (expressed as percentage water content, PWC). In addition to the primary research objective, several sub-studies will be conducted. These will include: (1) a longitudinal analysis of the effects of standard treatment; (2) an evaluation of the responsiveness and clinical utility of the BrEQ; and (3) a cross-sectional analysis of the compression pressure exerted by various compression bras. All sub-studies are methodologically feasible within the projected sample size of the primary objective and aim to provide supplementary insights into the clinical management of breast and truncal oedema.
Conditions
Conditions (4)
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 Related Lymphedema | — | UNRESOLVED | — |
| Breast Cancer Related Lymphoedema | — | UNRESOLVED | — |
| Breast Edema | — | UNRESOLVED | — |
| Truncal Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Compression bra (sub-study) | Other | — | UNRESOLVED |
| Decongestive lymphatic therapy | Other | — | UNRESOLVED |
| Kinesio tape | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control group (standard treatment)
- description
- Participants receive standard DLT, as described in the intervention section, consisting of two sessions per week over four weeks. Self-care activities are continued between sessions and recorded in a self-care diary.
- interventionNames
- Other: Decongestive lymphatic therapy
- Other: Compression bra (sub-study)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- Participants receive standard DLT, as described in the intervention section, delivered two times per week over four weeks. In addition, kinesio tape is applied to the affected area by a trained physiotherapist following a standardized protocol. Participants may continue kinesio tape use independently during the follow-up period. A kinesio tape diary is used to record kinesio tape usage.
- interventionNames
- Other: Decongestive lymphatic therapy
- Other: Kinesio tape
- Other: Compression bra (sub-study)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Female patients previously treated for breast cancer.
* Suffering from persistent (\>6 months) breast and/or truncal oedema, established at least six months after completion of radiotherapy.
* Objective measurements:
* BrEQ score ≥9.
* PWC (LymphScanner) showing at least one of the following:
* Truncal oedema: ratio ≥ 1.32.
* Breast oedema: ratio ≥ 1.28.
* Local PWC of 52.90%.
* Clinical evaluation:
* At least one positive sign of breast and/or truncal oedema such as:
* Visual swelling compared with the contralateral side.
* Visible imprint of the bra on the skin.
* Peau d'orange appearance on the breast.
Exclusion Criteria:
* Presence of skin infections or wounds of the breast/truncal region at the time of inclusion making it impossible to apply kinesio tape.
* Age under 18 years.
* Not able to read and understand Dutch language.
* Having received mastectomy.
* Metastatic breast cancer.References
Publications (6)
- BACKGROUNDMayrovitz HN, Somarriba C, Weingrad DN. Breast Tissue Dielectric Constant as a Potential Breast Edema Assessment Parameter. Lymphat Res Biol. 2022 Feb;20(1):33-38. doi: 10.1089/lrb.2020.0137. Epub 2021 Mar 24. PMID 33761280
- BACKGROUNDMayrovitz HN, Weingrad DN. Tissue dielectric constant ratios as a method to characterize truncal lymphedema. Lymphology. 2018;51(3):125-131. PMID 30422435
- BACKGROUNDExecutive Committee of the International Society of Lymphology. The diagnosis and treatment of peripheral lymphedema: 2020 Consensus Document of the International Society of Lymphology. Lymphology. 2020;53(1):3-19. PMID 32521126
- BACKGROUNDMazor M, Smoot BJ, Mastick J, Mausisa G, Paul SM, Kober KM, Elboim C, Singh K, Conley YP, Mickevicius G, Field J, Hutchison H, Miaskowski C. Assessment of local tissue water in the arms and trunk of breast cancer survivors with and without upper extremity lymphoedema. Clin Physiol Funct Imaging. 2019 Jan;39(1):57-64. doi: 10.1111/cpf.12541. Epub 2018 Sep 12. PMID 30207039
- BACKGROUNDVerbelen H, Gebruers N, Beyers T, De Monie AC, Tjalma W. Breast edema in breast cancer patients following breast-conserving surgery and radiotherapy: a systematic review. Breast Cancer Res Treat. 2014 Oct;147(3):463-71. doi: 10.1007/s10549-014-3110-8. Epub 2014 Aug 28. PMID 25164973
- BACKGROUNDVerbelen H, Tjalma W, Dombrecht D, Gebruers N. Breast edema, from diagnosis to treatment: state of the art. Arch Physiother. 2021 Mar 29;11(1):8. doi: 10.1186/s40945-021-00103-4. PMID 33775252