Effectiveness of Kinesio Taping in Patients With Chronic Breast and/or Truncal Oedema After Breast Cancer Treatment: A Randomized Controlled Trial

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
Iridium Network
RECRUITING
Antwerp
University of Antwerp
RECRUITING
Antwerp
Ghent University Hospital
RECRUITING
Ghent
AZ Groeninge
RECRUITING
Kortrijk
Contact Information
Primary
Tessa De Vrieze, Phd pt postdoctoral fellow
tessa.devrieze@uantwerpen.be
+32 472 74 16 77
Backup
Nick Gebruers, Associate Professor
nick.gebruers@uantwerpen.be
+32 496 18 43 46
Time Frame
Start Date: 2025-08-25
Estimated Completion Date: 2028-12
Participants
Target number of participants: 128
Treatments
Active_comparator: Control group (standard treatment)
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.
Experimental: Intervention group
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.
Related Therapeutic Areas
Sponsors
Collaborators: University Ghent, Iridium Network, AZ Groeninge
Leads: Universiteit Antwerpen

This content was sourced from clinicaltrials.gov