Effectiveness of Kinesio Taping in Patients With Chronic Breast and/or Truncal Oedema After Treatment for Breast Cancer.

Recruiting now · Not applicable

Conditions studied: Breast Edema, Breast Cancer Related Lymphoedema, Breast Cancer Related Lymphedema, Truncal Lymphedema

In brief

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.

Key facts

Study ID: NCT07080476
Run by: Universiteit Antwerpen
People needed: 128
Starts: 2025-08-25
Expected to finish: 2028-12-01
Last updated by the study team: 2025-09-03

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

University of Antwerp — Antwerp, Belgium (enrolling)
Iridium Network — Antwerp, Belgium (enrolling)
Ghent University Hospital — Ghent, Belgium (enrolling)
AZ Groeninge — Kortrijk, Belgium (enrolling)

Full record on ClinicalTrials.gov

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