RecruitingNot ApplicableNCT07080476

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

Sponsor

Universiteit Antwerpen

Enrollment

128 participants

Start Date

Aug 25, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Related Lymphedema Breast Edema Breast Cancer Related Lymphoedema Truncal Lymphedema

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a physical therapy technique called kinesio taping — applying special elastic tape to the skin — can help reduce swelling (oedema) in the breast and trunk area in women who have been treated for breast cancer and developed persistent lymphatic swelling as a side effect of their treatment. **You may be eligible if...** - You are a woman previously treated for breast cancer - You have persistent breast and/or trunk swelling that has lasted more than 6 months, starting at least 6 months after completing radiation therapy - Your swelling has been confirmed by objective measurements **You may NOT be eligible if...** - You have skin infections or open wounds in the area where the tape would be applied - You are under 18 years old - You cannot read or understand Dutch - You have had a mastectomy (full breast removal) - Your breast cancer has spread to other parts of the body (metastatic) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERDecongestive lymphatic therapy

Decongestive lymphatic therapy (DLT) is the current standard of care for lymphoedema management as recommended by the International Society of Lymphology (ISL). It consists of manual lymphatic drainage (MLD), skin care (education), compression therapy using a properly fitted compression bra, and supervised exercise therapy. Sessions last 45 minutes and are delivered two times per week for a period of four weeks. On non-treatment days, participants are encouraged to perform home exercises and document self-care practices in a diary.

OTHERKinesio tape

Kinesio tape will be applied by trained physiotherapists twice a week. The kinesio tape remains in place for three consecutive days and is replaced once a week. After six days of continuous use, patients will have one rest day without kinesio tape to allow the skin to recover. This cycle will be repeated for the duration of the intervention period. The kinesio tape will be applied using a standardised fan-cut technique to ensure consistent application across all study sites. Tape length will be individually tailored. Each application will consist of three fan-shaped strips: 1. Breast: Anchored at the ipsilateral axilla and directed vertically over the affected breast. 2. Ventral anastomosis: Originating from the contralateral axilla and applied horizontally over the chest. 3. Dorsal anastomosis: Also anchored at the healthy axilla and applied horizontally over the back. Patients will be instructed in safe self-application for potential use during follow-up.

OTHERCompression bra (sub-study)

In a subset of participants, different types of commercially available compression bras are tested for pressure and comfort. Each bra is worn for a period of one week without compromising the outcomes of the primary objective. The pressure exerted by the garment is measured using the PicoPress device on the first day of wear. The wearing comfort is evaluated using an adjusted version of the ICC compression questionnaire after one week of wearing the compression bra.