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

Официальное название

Effectiveness of Kinesio Taping in Patients With Chronic Breast and/or Truncal Oedema After Breast Cancer Treatment: A Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

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.

Вмешательства

• Другое 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 do
• Другое 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
• Другое 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.

Первичные конечные точки

• Change in Breast Edema Questionnaire (BrEQ) score [Срок оценки: From baseline to the end of one month of treatment]

Вторичные конечные точки (10)

• Change in local tissue water (PWC) [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: 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) [Срок оценки: 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. [Срок оценки: 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). [Срок оценки: 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. [Срок оценки: From the end of the 4-week intervention period to the 6-months follow-up measurements.]
• Responsiveness of the BrEQ (substudy) [Срок оценки: From baseline to one month of intervention (intensive group); and 3 and 4 months post-intervention (maintenance group).]
• Pressure under compression bras (substudy) [Срок оценки: First day of wearing the compression bra.]
• Comfort of a compression bra (substudy) [Срок оценки: After one week of wearing the specific compression bra.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Бельгия · 4 центра

• University of Antwerp — Antwerp
• Iridium Network — Antwerp
• Ghent University Hospital — Ghent
• AZ Groeninge — Kortrijk

Публикации

• 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 33761280
• Mayrovitz HN, Weingrad DN. Tissue dielectric constant ratios as a method to characterize truncal lymphedema. Lymphology. 2018;51(3):125-131. PMID 30422435
• 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. PMID 32521126
• 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. PMID 30207039
• 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. PMID 25164973
• 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. PMID 33775252

Идентификаторы

NCT: NCT07080476 · 53270

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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