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.
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.
BrEQ score ≥9.
Truncal oedema: ratio ≥ 1.32.
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.
Parallel
Decongestive lymphatic therapy
Other interventionDecongestive 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
Other interventionKinesio 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)
Other interventionIn 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.
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.
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.
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.
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.
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.
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Universiteit Antwerpen
Lead sponsor
University Ghent
Collaborator
Iridium Network
Collaborator
AZ Groeninge
Collaborator
