Kinesio taping for chronic breast and truncal oedema after breast cancer treatment
Effectiveness of Kinesio Taping in Patients With Chronic Breast and/or Truncal Oedema After Breast Cancer Treatment: A Randomized Controlled Trial
This trial tests whether adding kinesio tape to standard decongestive lymphatic therapy helps women with persistent (more than 6 months) breast or truncal swelling after breast cancer treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Universiteit Antwerpen Academic / other |
| Locations | 4 sites (Antwerp and 3 other locations) |
| Trial ID | NCT07080476 on ClinicalTrials.gov |
What this trial studies
About 128 women with persistent breast and/or truncal oedema will be randomly assigned to receive standard decongestive lymphatic therapy (DLT) alone or DLT plus kinesio taping. The active treatment phase lasts 4 weeks with two sessions per week, followed by a 6-month follow-up to track durability of effects and cost-related outcomes. Outcomes include symptom burden (BrEQ), local tissue water (PWC), pain (VAS), and quality of life (EQ-5D-5L and EORTC-QLQ-BR23). Three embedded sub-studies will examine the longitudinal effect of DLT, the responsiveness of the BrEQ questionnaire, and a compression-bra sub-study.
Who should consider this trial
Good fit: Women previously treated for breast cancer who have persistent (≥6 months) breast and/or truncal oedema with objective signs (BrEQ ≥9 and PWC above specified thresholds), who have not had a mastectomy, do not have metastatic disease, have no skin infections, and can read Dutch are ideal candidates.
Not a fit: Patients who have had a mastectomy, have metastatic disease, have active skin infections or wounds that prevent tape application, cannot read Dutch, or whose swelling began less than six months after treatment are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, adding kinesio tape could reduce pain and swelling and improve quality of life for women with persistent post-treatment breast or truncal oedema.
How similar studies have performed: Decongestive lymphatic therapy is an established treatment, but prior small studies of kinesio taping for lymphedema have shown mixed or inconclusive results, so the additive benefit remains unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Where this trial is running
Antwerp and 3 other locations
- University of Antwerp — Antwerp, Belgium (Recruiting)
- Iridium Network — Antwerp, Belgium (Recruiting)
- Ghent University Hospital — Ghent, Belgium (Recruiting)
- AZ Groeninge — Kortrijk, Belgium (Recruiting)
Study contacts
- Study coordinator: Tessa De Vrieze, Phd pt postdoctoral fellow
- Email: tessa.devrieze@uantwerpen.be
- Phone: +32 472 74 16 77
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.