NCT07080476

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Universiteit Antwerpen · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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. 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

• Breast Edema
• Breast Cancer Related Lymphoedema
• Breast Cancer Related Lymphedema
• Truncal Lymphedema

Interventions

Type	Name	Description
OTHER	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.
OTHER	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.
OTHER	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.

Timeline

• Start date: 2025-08-25
• Primary completion: 2028-04-30
• Completion: 2028-12-01
• First posted: 2025-07-23
• Last updated: 2025-09-03

Locations

4 sites across 1 country: Belgium