Effectiveness of Kinesio Taping in Patients With Chronic Breast and/or Truncal Oedema After Treatment for Breast Cancer.
KiTaLymph
1 other identifier
interventional
128
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2025
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2025
CompletedFirst Posted
Study publicly available on registry
July 23, 2025
CompletedStudy Start
First participant enrolled
August 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
September 3, 2025
August 1, 2025
2.7 years
July 14, 2025
August 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Breast Edema Questionnaire (BrEQ) score
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 oedema symptoms. A total score of ≥9 has been identified as the optimal cut-off point to discriminate between patients with and without breast oedema. The primary comparison will assess group differences in BrEQ score after one month of treatment.
From baseline to the end of one month of treatment
Secondary Outcomes (10)
Change in local tissue water (PWC)
From baseline to the end of the treatment period (1 month), and 3 and 6 months after the end of the treatment.
Change in pain intensity (VAS).
From baseline to the end of the treatment period (1 month), and 3 and 6 months after the end of the treatment.
Change in quality of life (EORTC-QLQ-BR23).
From baseline to the end of the treatment period (1 month), and 3 and 6 months after the end of the treatment.
Change in quality of life (EQ-5D-5L)
From baseline to the end of the treatment period (1 month), and 3 and 6 months after the end of the treatment.
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.
- +5 more secondary outcomes
Study Arms (2)
Control group (standard treatment)
ACTIVE COMPARATORParticipants 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.
Intervention group
EXPERIMENTALParticipants 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.
Interventions
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.
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.
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.
Eligibility Criteria
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:
- Age under 18 years.
- Not able to read and understand Dutch language.
- Having received mastectomy.
- Metastatic breast cancer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universiteit Antwerpenlead
- University Ghentcollaborator
- Iridium Networkcollaborator
- AZ Groeningecollaborator
Study Sites (4)
University of Antwerp
Antwerp, 2000, Belgium
Iridium Network
Antwerp, 2610, Belgium
Ghent University Hospital
Ghent, 9000, Belgium
AZ Groeninge
Kortrijk, 8500, Belgium
Related Publications (6)
Mayrovitz HN, Somarriba C, Weingrad DN. Breast Tissue Dielectric Constant as a Potential Breast Edema Assessment Parameter. Lymphat Res Biol. 2022 Feb;20(1):33-38. doi: 10.1089/lrb.2020.0137. Epub 2021 Mar 24.
PMID: 33761280BACKGROUNDMayrovitz HN, Weingrad DN. Tissue dielectric constant ratios as a method to characterize truncal lymphedema. Lymphology. 2018;51(3):125-131.
PMID: 30422435BACKGROUNDExecutive Committee of the International Society of Lymphology. The diagnosis and treatment of peripheral lymphedema: 2020 Consensus Document of the International Society of Lymphology. Lymphology. 2020;53(1):3-19.
PMID: 32521126BACKGROUNDMazor M, Smoot BJ, Mastick J, Mausisa G, Paul SM, Kober KM, Elboim C, Singh K, Conley YP, Mickevicius G, Field J, Hutchison H, Miaskowski C. Assessment of local tissue water in the arms and trunk of breast cancer survivors with and without upper extremity lymphoedema. Clin Physiol Funct Imaging. 2019 Jan;39(1):57-64. doi: 10.1111/cpf.12541. Epub 2018 Sep 12.
PMID: 30207039BACKGROUNDVerbelen H, Gebruers N, Beyers T, De Monie AC, Tjalma W. Breast edema in breast cancer patients following breast-conserving surgery and radiotherapy: a systematic review. Breast Cancer Res Treat. 2014 Oct;147(3):463-71. doi: 10.1007/s10549-014-3110-8. Epub 2014 Aug 28.
PMID: 25164973BACKGROUNDVerbelen H, Tjalma W, Dombrecht D, Gebruers N. Breast edema, from diagnosis to treatment: state of the art. Arch Physiother. 2021 Mar 29;11(1):8. doi: 10.1186/s40945-021-00103-4.
PMID: 33775252BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 14, 2025
First Posted
July 23, 2025
Study Start
August 25, 2025
Primary Completion (Estimated)
April 30, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
September 3, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
Data will be shared "as open as possible, as closed as needed", according to the FAIR principles. Data will be made available upon reasonable request.