Effectiveness of Kinesio Taping in Patients With Chronic Breast and/or Truncal Oedema After Treatment for Breast Cancer.
NCT ID: NCT07080476
Last Updated: 2025-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
128 participants
INTERVENTIONAL
2025-08-25
2028-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Kinesio Taping Versus Compression Garments for Breast Cancer-Related Lymphedema
NCT03051776
Comparison of Kinesiotaping and Pressure Garment on Women With Upper Extremity Lymphedema Following Mastectomy
NCT03401086
Kinesiology Taping Technique in Post-mastectomy Breast Cancer Related Lymphedema
NCT05178797
Effectiveness of Taping on Anastomotic Regions in Patients With Breast Cancer-Related Lymphoedema
NCT03765996
Comparison of Techniques for Breast Cancer-Related Lymphedema.
NCT03051750
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. The longitudinal effect of decongestive lymphatic therapy:
This sub-study examines the (long-term) effect of DLT on symptoms and functioning in women with persistent breast and/or truncal 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 after the end of the intervention.
No additional intervention is introduced beyond the standard treatment already described in the main study protocol. The sub-study 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 sub-study 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 interventions. Two subgroups will be analysed: (1) the intensive phase group (from baseline to one month after the start of the intervention), in which clinical improvement is expected, and (2) the maintenance phase group (from three to four months after the end of 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 sub-study requires no additional interventions and uses existing follow-up time points supplemented by one extra BrEQ and GPE assessment at four months after the end of the intervention.
3. Pressure and comfort of compression bras:
This sub-study 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 (five participants per 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Decongestive 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.
Compression 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.
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.
Decongestive 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.
Kinesio 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.
Compression 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Decongestive 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.
Kinesio 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.
Compression 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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* Age under 18 years.
* Not able to read and understand Dutch language.
* Having received mastectomy.
* Metastatic breast cancer.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Ghent
OTHER
Iridium Network
UNKNOWN
AZ Groeninge
UNKNOWN
Universiteit Antwerpen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nick Gebruers
Associate Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Antwerp
Antwerp, , Belgium
Iridium Network
Antwerp, , Belgium
Ghent University Hospital
Ghent, , Belgium
AZ Groeninge
Kortrijk, , Belgium
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Mayrovitz HN, Weingrad DN. Tissue dielectric constant ratios as a method to characterize truncal lymphedema. Lymphology. 2018;51(3):125-131.
Executive 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.
Mazor 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.
Verbelen 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.
Verbelen 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
53270
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.