Breast EdemaKiTaLymphNCT07080476
Effectiveness of Kinesio Taping in Patients With Chronic Breast and/or Truncal Oedema After Treatment for Breast Cancer.
A study testing Decongestive lymphatic therapy, Kinesio tape and Compression bra (sub-study) in people with Breast Edema and Breast Cancer Related Lymphoedema, run by Universiteit Antwerpen at 4 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Edema, Breast Cancer Related Lymphoedema, Breast Cancer Related Lymphedema
- What is being tested?
- Decongestive lymphatic therapy, Kinesio tape and Compression bra (sub-study)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 4 sitesBelgium
- Study dates
- 25 Aug 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 13Show fewer
- 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.
Who cannot join
- Presence of skin infections or wounds of the breast/truncal region at the time of inclusion making it impossible to apply kinesio tape.
- Age under 18 years.
- Not able to read and understand Dutch language.
- Having received mastectomy.
- Metastatic breast cancer.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium4 sites, 4 recruiting
- Recruiting
University of Antwerp
Antwerp, 2000
Heleen Leurs, +32 488 77 47 79, heleen.leurs@uantwerpen.be
Nick Gebruers, +32 3 265 28 76, nick.gebruers@uantwerpen.be
- Recruiting
Iridium Network
Antwerp, 2610
Machiels Melanie, +32492415905, Melanie.Machiels@zas.be
- Recruiting
Ghent University Hospital
Ghent, 9000
Chris Monten, 093 32 30 15, chris.monten@uzgent.be
- Recruiting
AZ Groeninge
Kortrijk, 8500
Marianne Hanssens, 056 63 39 00, marianne.hanssens@azgroeninge.be
About this study
Official title: Effectiveness of Kinesio Taping in Patients With Chronic Breast and/or Truncal Oedema After Breast Cancer Treatment: A Randomized Controlled Trial
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:
Read more
- 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.
Read the detailed description
As outlined in the brief summary, three sub-studies will be embedded within the main study sample. The following section provides a concise overview of the methodological approach for each of these sub-studies.
- 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.
- 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.
- 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
- Breast Edema, Breast Cancer Related Lymphoedema, Breast Cancer Related Lymphedema, Truncal Lymphedema
- Being tested
- Decongestive lymphatic therapy, Kinesio tape, Compression bra (sub-study)
- Keywords
- RCT, Decongestive Lymphatic Therapy (DLT), Health-related quality of life (HRQoL), Breast cancer, Kinesio taping, Breast oedema
- Medical subject headings
- Breast Cancer Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decongestive lymphatic therapyOther
Also called DLT, complex decongestive 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 tapeOther
Also called kinesiotape, kinesio tapes, kinesio taping, kinesiology taping
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:
- Breast: Anchored at the ipsilateral axilla and directed vertically over the affected breast.
- Ventral anastomosis: Originating from the contralateral axilla and applied horizontally over the chest.
- 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)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group (standard treatment) | Active comparator | 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. Receives: Other: Decongestive lymphatic therapy; Other: Compression bra (sub-study) |
| Intervention group | Experimental | 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. Receives: Other: Decongestive lymphatic therapy; Other: Kinesio tape; Other: Compression bra (sub-study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to the end of one month of treatment
Secondary outcomes (10)
Change in local tissue water (PWC)
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 water. Changes over time reflect progression or reduction of oedema.
Measured: 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).
Pain intensity is assessed with the Visual Analogue Scale (VAS), a validated 10-cm horizontal scale on which participants indicate their perceived pain level. The 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 reduction in pain severity.
Measured: 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).
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.
Measured: 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)
The EQ-5D-5L is a standardised 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.
Measured: 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.
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: skin care, compression therapy, exercises, physiotherapy and a few additional questions.
Measured: From enrollment to the end of the study at 7 months.
Feasibility and self-reported use of kinesio tape during follow-up as documented in a diary (intervention group only).
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.
Measured: From the end of the 4-week intervention period to the 6-month follow-up measurement.
Change in Breast Edema Questionnaire (BrEQ) score at 3 and 6 months post end of treatment.
The BrEQ is a validated patient-reported measure of breast oedema 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.
Measured: From the end of the 4-week intervention period to the 6-months follow-up measurements.
Responsiveness of the BrEQ (substudy)
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.
Measured: From baseline to one month of intervention (intensive group); and 3 and 4 months post-intervention (maintenance group).
Pressure under compression bras (substudy)
Pressure (in mmHg) exerted by different commercially available compression bras will be measured using the PicoPress device.
Measured: First day of wearing the compression bra.
Comfort of a compression bra (substudy)
Patient-reported comfort is assessed using an adjusted version of the International Compression Club Compression Questionnaire (ICC-CQ), patient version. The questionnaire includes items about putting on and taking off the compression garment, perceived comfort, and any side effects experienced. It consists of yes/no questions and items rated on an 11-point Likert scale (0-10).
Higher scores indicate greater ease in putting on and taking off the garment, greater comfort, and more side effects, respectively. No total or summary scores are calculated.
Measured: After one week of wearing the specific compression bra.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start25 Aug 2025
- Primary completion30 Apr 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, Iridium Network, AZ Groeninge
- Responsible party
- Principal investigator, Nick Gebruers, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080476
- Sponsor's protocol ID
- 53270
- Acronym
- KiTaLymph
- Status last verified
- Aug 2025
- First submitted
- 14 Jul 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 33761280Mayrovitz HN, Weingrad DN. Tissue dielectric constant ratios as a method to characterize truncal lymphedema. Lymphology. 2018;51(3):125-131.
PubMed 30422435Executive 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.
PubMed 32521126Mazor 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.
PubMed 30207039Verbelen 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.
PubMed 25164973Verbelen 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.
PubMed 33775252
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Kinesio Taping in Patients With Chronic Breast and/or Truncal Oedema After Breast Cancer Treatment: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07080476
- Acronym / sponsor ID
- KiTaLymph / 53270
- Conditions
- Breast Edema, Breast Cancer Related Lymphoedema, Breast Cancer Related Lymphedema, Truncal Lymphedema
- Keywords
- RCT, Decongestive Lymphatic Therapy (DLT), Health-related quality of life (HRQoL), Breast cancer, Kinesio taping, Breast oedema
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- University Ghent, Iridium Network, AZ Groeninge
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
As outlined in the brief summary, three sub-studies will be embedded within the main study sample. The following section provides a concise overview of the methodological approach for each of these sub-studies.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Control group (standard treatment) | Active comparator | Other: Decongestive lymphatic therapy, Other: Compression bra (sub-study)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. |
| Intervention group | Experimental | Other: Decongestive lymphatic therapy, Other: Kinesio tape, Other: Compression bra (sub-study)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- Clinical evaluation:
Key exclusion criteria (5 listed)
- Presence of skin infections or wounds of the breast/truncal region at the time of inclusion making it impossible to apply kinesio tape.
- Age under 18 years.
- Not able to read and understand Dutch language.
- Having received mastectomy.
- Metastatic breast cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decongestive lymphatic therapyAlso: DLT, complex decongestive therapyDecongestive 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. | Other | Control group (standard treatment), Intervention group |
| Kinesio tapeAlso: kinesiotape, kinesio tapes, kinesio taping, kinesiology tapingKinesio 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. | Other | Intervention group |
| 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 | Control group (standard treatment), Intervention group |
Primary outcome
Change in Breast Edema Questionnaire (BrEQ) score
Time frame: 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 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.
10 secondary outcomes
Change in local tissue water (PWC)
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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.
Time frame: From enrollment to the end of the study at 7 months.
Feasibility and self-reported use of kinesio tape during follow-up as documented in a diary (intervention group only).
Time frame: From the end of the 4-week intervention period to the 6-month follow-up measurement.
Change in Breast Edema Questionnaire (BrEQ) score at 3 and 6 months post end of treatment.
Time frame: From the end of the 4-week intervention period to the 6-months follow-up measurements.
Responsiveness of the BrEQ (substudy)
Time frame: From baseline to one month of intervention (intensive group); and 3 and 4 months post-intervention (maintenance group).
Pressure under compression bras (substudy)
Time frame: First day of wearing the compression bra.
Comfort of a compression bra (substudy)
Time frame: After one week of wearing the specific compression bra.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Background: PubMed 33761280Mayrovitz 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.
- Background: PubMed 30422435Mayrovitz HN, Weingrad DN. Tissue dielectric constant ratios as a method to characterize truncal lymphedema. Lymphology. 2018;51(3):125-131.
- Background: PubMed 32521126Executive 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.
- Background: PubMed 30207039Mazor 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.
- Background: PubMed 25164973Verbelen 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.
- Background: PubMed 33775252Verbelen 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Breast Edema
Active, not recruitingPhase 2
Carboplatin and Paclitaxel With or Without Panitumumab in Treating Patients With Invasive Triple Negative Breast Cancer
Breast Carcinoma, Breast Lump
Active, not recruitingPhase 2
Pembrolizumab in Treating Patients With Stage IV Metastatic or Recurrent Inflammatory Breast Cancer or Triple-Negative Breast Cancer Who Have Achieved Clinical Response or Stable Disease to Prior Chemotherapy
Edema, Erythema
RecruitingObservational study
Screening For BCRL In Targeted Therapy For Breast Cancer
Lymphedema, Lymphedema Arm
Not yet recruiting
Combined Exercise Effects in Breast Cancer-related Lymphedema
Breast Cancer-Related Lymphedema
Enrolling by invitationObservational study
The BEACON Trial: Diagnostic Tools for Breast Lymphedema After Treatment for Breast Cancer
Breast Edema, Breast Lymphedema
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decongestive lymphatic therapy, Kinesio tape and Compression bra (sub-study) in people with Breast Edema and Breast Cancer Related Lymphoedema, run by Universiteit Antwerpen at 4 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tessa De Vrieze, Phd pt postdoctoral fellow (+32 472 74 16 77, tessa.devrieze@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Breast Edema Questionnaire (BrEQ) score (time frame: From baseline to the end of one month of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07080476, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.