NCT07080476 Effectiveness of Kinesio Taping in Patients With Chronic Breast and/or Truncal Oedema After Treatment for Breast Cancer.
| NCT ID | NCT07080476 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universiteit Antwerpen |
| Condition | Breast Edema |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2025-08-25 |
| Primary Completion | 2028-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 128 participants in total. It began in 2025-08-25 with a primary completion date of 2028-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07080476 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Edema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07080476 currently recruiting?
Yes, NCT07080476 is actively recruiting participants. Contact the research team at tessa.devrieze@uantwerpen.be for enrollment information.
Where is the NCT07080476 trial being conducted?
This trial is being conducted at Antwerp, Belgium, Antwerp, Belgium, Ghent, Belgium, Kortrijk, Belgium.
Who is sponsoring the NCT07080476 clinical trial?
NCT07080476 is sponsored by Universiteit Antwerpen. The trial plans to enroll 128 participants.