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

Not Applicable

Not yet recruiting

• Conditions: Breast Edema; Breast Cancer Related Lymphoedema; Breast Cancer Related Lymphedema; Truncal Lymphedema

• Registration Number: NCT07080476
• Lead Sponsor: Universiteit Antwerpen

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 trunk 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 conclusion of the intervention. These assessments will include standardized 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 ancillary sub-studies will be conducted. These will include: (1) a longitudinal analysis of the effects of standard treatment over time; (2) an evaluation of the responsiveness and clinical utility of the BrEQ; and (3) a cross-sectional investigation of the compression pressure exerted by various compression bras. All sub-studies are methodologically feasible within the projected sample size of the primary trial and aim to provide supplementary insights into the clinical management of breast and truncal oedema.

Detailed Description

As outlined in the brief summary, three substudies will be embedded within the main study sample. The following section provides a concise overview of the methodological approach for each of these substudies.

1. The longitudinal effectof Decongestive Lymphatic Therapy:

This substudy examines the (long-term) effect of standard decongestive lymphatic therapy (DLT) on symptoms and functioning in women with persistent breast and/or trunk oedema following breast cancer treatment. The analysis will focus on participants in the control group, who receive DLT alone. Outcomes such as symptom burden (BrEQ), local tissue water (PWC%), pain (VAS), and quality of life (EQ-5D-5L and EORTC QLQ-BR23) will be tracked at multiple time points: baseline, after 1 month of intervention, and 3 and 6 months post-end of intervention.

No additional intervention is introduced beyond the standard treatment already described in the main study protocol. The substudy will assess the sustainability of symptom improvement over time and provide insight into the standalone effectiveness of DLT.

2. Responsiveness of the Breast Edema Questionnaire:

This substudy aims to evaluate the responsiveness of the BrEQ, a validated questionnaire used to assess symptoms related to breast oedema. Although the BrEQ has demonstrated strong psychometric properties, its ability to detect clinically meaningful changes over time has not yet been investigated.

Participants from both groups in the main study can participate in this sub-study. The design follows a longitudinal cohort structure integrated into the RCT, without any additional intervention. Two subgroups will be analysed: (1) the intensive phase group (from baseline to one month after the intervention), in which clinical improvement is expected, and (2) the maintenance phase group (from three to four months after the intervention), in which symptom levels are expected to remain stable.

In both groups, BrEQ scores will be compared with patient-reported change using the Global Perceived Effect (GPE) scale. Responsiveness will be quantified through Receiver Operating Characteristic (ROC) curve analysis, and effect size calculations (Cohen's d, Standardized Response Mean). This substudy requires no additional intervention and uses existing follow-up time points supplemented by one extra BrEQ and GPE assessment at four months post-end of intervention.

3. Pressure and comfort of compression bras:

This substudy investigates the pressure exerted by different commercially available compression bras and evaluates patient-reported comfort. The goal is to assess whether these garments provide adequate therapeutic compression and are acceptable for daily use.

The design follows a cross-sectional approach conducted in a subset of participants (5 participants/cup size) who consent to this additional component. Each participating patient will receive different compression bras, worn for one week each.

Pressure beneath the garment will be measured using the PicoPress device (Microlab, Italy) on the first day of wear. After each one-week wear period, participants will complete an adapted version of the ICC Compression Questionnaire (ICC-CQ) to assess comfort and usability.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-14
• Study Start: 2025-07-16
• Study First Submitted QC: 2025-07-22
• Last Update Submitted: 2025-07-22
• Study First Posted: 2025-07-23
• Last Update Posted: 2025-07-23
• Primary Completion: 2028-04-30
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 128

Inclusion Criteria

• Female patients previously treated for breast cancer.

• Suffering from persistent (>6 months) breast and/or trunk oedema, established at least six months after completion of radiotherapy.

• Objective measurement:

  • BrEQ score ≥9.

  • PWC% (LymphScanner) showing at least one of the following:

    • Trunk 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 flank 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 tape.
• Age under 18 years.
• Not able to read and understand Dutch language.
• Having received mastectomy.
• Metastatic breast cancer.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Breast Edema Questionnaire (BrEQ) score	From baseline to the end of one month of treatment	The Breast Edema Questionnaire (BrEQ) is a validated Dutch patient-reported outcome measure designed to assess the impact of breast oedema. Part 1 of the BrEQ evaluates eight symptoms: pain, heaviness, swelling, tensed skin, redness, pitting sign, enlarged skin pores, and hardness. Each symptom is scored on an 11-point Likert scale ranging from 0 ("not at all") to 10 ("very severe"), resulting in a total symptom score ranging from 0 to 80. Higher scores indicate greater severity of breast edema symptoms. A total score of ≥9 has been identified as the optimal cut-off point to discriminate between patients with and without breast edema. The primary comparison will assess group differences in BrEQ score after one month of treatment

Secondary Outcome Measures

Name	Time	Method
Change in Local Tissue Water (PWC%)	From baseline to 1 month post treatment, and 3 and 6 months post-end of treatment.	The LymphScanner is a non-invasive diagnostic device used to objectively measure percentage water content (PWC%) in subcutaneous tissue. It uses tissue dielectric constant (TDC) technology to assess local water levels. Measurements are taken at standardised points on the breast and trunk from which ratios are calculated to monitor evolution. Higher PWC% values indicate higher levels of local tissue fluid. Changes over time reflect progression or reduction of oedema.
Change in pain intensity (VAS).	From baseline to one month post treatment and 3 and 6 month post- end of intervention.	Pain intensity is assessed with the Visual Analogue Scale (VAS), a validated 10-cm horizontal scale on which participants indicate their perceived pain level. Scores range from 0 (no pain) to 10 (worst pain). The outcome is the change in VAS scores over time. A decrease in score indicates a decrease in pain severity.
Change in quality of life (EORTC-QLQ-BR23).	From baseline to after one month of treatment and 3 and 6 month post-end of treatment.	The EORTC-QLQ-BR23 is a breast cancer-specific quality of life questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC). It assesses the quality of life in breast cancer patients, focusing on aspects like body image, sexual functioning, treatment side effects and emotional well-being. Scores for each domain are linearly transformed to a 0-100 scale. Higher scores on functional scales indicate better functioning, while higher scores on symptom scales indicate more severe symptoms.
Change in quality of life (EQ-5D-5L)	From baseline to after one month of treatment and 3 and 6 months post-end of intervention.	The EQ-5D-5L is a standardized tool for measuring health-related quality of life in breast cancer patients. It consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on five levels of severity. The questionnaire also includes a visual analogue scale, where patients rate their overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable). The outcome is the change from baseline in both the index-based utility score and VAS score.
Documentation of self-reported standard care practices using a self-care diary during the intervention and follow-up periods.	From enrollment to the end of the study at 7 months.	A self-developed diary for standard care, which is a comprehensive tool designed to track various aspects of standard care during the intervention period and follow-up. Its primary purpose is to provide a detailed record of essential care practices, ensuring participants follow the recommended protocols and enabling investigators to monitor progress accurately.; The diary will cover several key areas: skincare, compression therapy, exercises, physiotherapy and a few additional questions.
Feasibility and self-reported use of kinesio tape during follow-up as documented in a diary (intervention group only).	From the end of the 4-week intervention period to the 6-month follow-up measurement.	A self-developed diary for assessing the feasibility of kinesio tape application. This diary tracks when the tape is applied, how long it is worn, and evaluates how feasible it is for the patient to apply it independently. Additionally, it monitors costs to determine the cost-effectiveness of kinesio taping.
Change in Breast Edema Questionnaire (BrEQ) score at 3 and 6 months post end of treatment.	From the end of the 4-week intervention period to the 6-months follow-up measurements.	The BrEQ is a validated patient-reported measure of breast edema symptoms. Part 1 includes 8 items scored from 0 (not at all) to 10 (very severe), with a total score ranging from 0 to 80. Higher scores indicate worse symptoms. A score of ≥9 indicates presence of breast oedema.
Responsiveness of the BrEQ (substudy)	From baseline to one month of intervention (intensive group); and 3 and 4 months post-intervention (maintenance group).	The responsiveness of the BrEQ analysed via comparison with the Global Perceived Effect (GPE) scale and ROC analysis. Additional analyses include Cohen's d and SRM.
Pressure under compression bras (substudy)	First day of wearing the compression bra.	Pressure (in mmHg) exerted by different commercially available compression bras will be measured using the PicoPress device.
Comfort of a compression bra (substudy)	After one week of wearing the specific compression bra.	Patient-reported comfort assessed using an adapted version of the ICC compression Questionnaire (ICC-CQ).

Trial Locations

Locations (4)

Iridium Network; 🇧🇪 Antwerpen, Belgium

University of Antwerp; 🇧🇪 Antwerp, Belgium

Ghent University Hospital; 🇧🇪 Gent, Belgium

AZ Groeninge; 🇧🇪 Kortrijk, Belgium