Efficacy of Kinesio Taping Versus Compression Therapy on Breast Lymphedema Induced by Radiotherapy After Breast-Conserving Surgery

NCT07767305 | Recruiting

• 1 other identifier: RMYY- LLKS-2025304
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer patients often develop breast lymphedema after breast-conserving surgery and radiotherapy, causing swelling, pain, and heaviness that affect quality of life. This study compares two physical therapy approaches-Kinesio Taping and compression therapy-for relieving breast lymphedema. Kinesio Taping is an elastic medical tape applied to the breast skin to promote lymphatic drainage; compression therapy uses an adjustable pressure vest to reduce swelling through external pressure. The study will enroll 99 eligible postoperative breast cancer patients, randomly assigned to three groups: one receiving routine care, one receiving routine care plus Kinesio Taping, and one receiving routine care plus compression therapy, with a 6-week intervention period. Assessments will be conducted at baseline, immediately after intervention, and at 3 and 6 months post-intervention to compare changes in swelling, pain, and quality of life among the three groups. This study has been approved by the Medical Ethics Committee of Tangshan People's Hospital (LLKS), and all participants voluntarily participate with signed informed consent.

Conditions

Breast Cancer; Breast Lymphedema

Keywords

Kinesio Taping; Compression Therapy; Breast-Conserving Surgery; Breast Lymphedema

Outcome Measures

Primary Outcomes (1)

• Lymphedema-Related Symptoms (VAS)

  Visual Analog Scale (VAS) assessing patient-reported severity of breast pain, swelling, heaviness, and tightness. Each symptom is scored from 0 (no symptom) to 10 (extremely severe).

  Baseline (T0), immediately post-intervention at 6 weeks (T1), 3 months post-intervention (T2), and 6 months post-intervention (T3)

Secondary Outcomes (5)

• Ultrasound-Measured Breast Skin Thickness

  Baseline (T0), immediately post-intervention at 6 weeks (T1), 3 months post-intervention (T2), and 6 months post-intervention (T3)

• Breast Circumference Measures

  Baseline (T0), immediately post-intervention at 6 weeks (T1), 3 months post-intervention (T2), and 6 months post-intervention (T3)

• Quality of Life (FACT-B)

  Baseline (T0), immediately post-intervention at 6 weeks (T1), 3 months post-intervention (T2), and 6 months post-intervention (T3)

• Self-Efficacy (BCSES)

  Baseline (T0), immediately post-intervention at 6 weeks (T1), 3 months post-intervention (T2), and 6 months post-intervention (T3)

• Anxiety and Depression (HADS)

  Baseline (T0), immediately post-intervention at 6 weeks (T1), 3 months post-intervention (T2), and 6 months post-intervention (T3)

Study Arms (3)

Control Group

ACTIVE COMPARATOR

Routine care including health education, breast and skin care, lifestyle guidance, and rehabilitation exercises.

Other: Routine Care

Kinesio Taping Group

EXPERIMENTAL

Participants receive routine care (health education, breast and skin care, lifestyle guidance, and rehabilitation exercises) plus Kinesio Taping applied to the affected breast. The tape is applied in a fan-shaped pattern around the breast area, retained for 3 days, followed by 1 day of rest, repeated over a 6-week period.

Other: Kinesio Taping

Compression Therapy Group

EXPERIMENTAL

Participants receive routine care (health education, breast and skin care, lifestyle guidance, and rehabilitation exercises) plus compression therapy using an adjustable compression vest. The vest is worn for 15-18 hours per day, with pressure maintained at 18-21 mmHg, over a 6-week period.

Other: Compression Therapy

Interventions

Routine Care OTHER

Health education including explanation of breast lymphedema mechanisms and complications; breast and skin care instructions (cleaning with warm water and mild cleanser, avoiding irritants, wearing loose clothing, avoiding sun exposure for 6 months after radiotherapy); lifestyle guidance (high-protein, high-vitamin, low-fat diet, adequate sleep, proper positioning to promote lymphatic drainage); and rehabilitation exercises (range of motion exercises for the affected upper extremity, performed 1-2 times daily, 10-20 minutes per session, over a 6-week period).

Control Group

Kinesio Taping OTHER

Elastic therapeutic tape (KT TAPE, 25 cm × 5 cm pre-cut) applied to the affected breast. Prior to application, a 2 cm × 2 cm test tape is applied to the forearm for 24 hours to rule out allergy. The tape is cut into a fan shape with 4 tails, anchored below the clavicle, and applied diagonally around the breast area with no tension on the tails, covering the edematous area without overlapping. Each application is retained for 3 days, followed by 1 day of rest, repeated over a 6-week period. Participants are instructed on proper removal techniques (skin-pressing and rolling methods) to avoid skin damage.

Kinesio Taping Group

Compression Therapy OTHER

Adjustable compression vest made of medical-grade material with a modal inner layer, featuring adjustable Velcro straps on the affected side. Pressure is calibrated using a German precision pressure measurement device, with the sensor placed on the lower outer quadrant of the affected breast to maintain pressure at 18-21 mmHg. The vest is worn for 15-18 hours per day (daytime only, not at night) for 6 weeks. Participants are instructed to discontinue use immediately if they experience dyspnea or chest tightness.

Compression Therapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of unilateral breast cancer confirmed according to the Chinese Anti-Cancer Association Breast Cancer Diagnosis and Treatment Guidelines and Standards (2024 edition).
• Underwent breast-conserving surgery and completed breast radiotherapy for at least 2 months prior to enrollment; skin toxicity ≤ Grade 1 according to the Radiation Therapy Oncology Group (RTOG) acute radiation morbidity scoring criteria.
• Age ≥ 18 years.
• Ultrasound-diagnosed breast lymphedema in at least one quadrant of the affected breast exceeding the following thresholds: upper outer quadrant thickness ≥ 2.5 mm, upper inner quadrant ≥ 3.0 mm, lower outer quadrant ≥ 2.3 mm, lower inner quadrant ≥ 2.6 mm.
• Presence of breast lymphedema symptoms (breast swelling, peau d'orange appearance, redness, positive Stemmer's sign) confirmed by clinical diagnosis.
• Ability to understand and communicate effectively, capable of completing questionnaires.
• Willing to provide written informed consent to participate in the study.

You may not qualify if:

• Cognitive impairment or communication dysfunction.
• Severe psychological disorders or psychiatric illness.
• Postoperative cancer recurrence or metastasis with serious complications.
• Other causes of breast swelling unrelated to breast cancer.
• Severe liver or kidney disease, cardiovascular disease, deep vein thrombosis, heart failure, lymphangitis, or current antibiotic treatment for cellulitis that would preclude participation.
• Allergy to Kinesio Tape.

Sponsors & Collaborators

• Tangshan People's Hospital: lead

Study Sites (1)

Tangshan People's Hospital

Tangshan, Hebei, 063000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors (ultrasound examiners and questionnaire collectors) were blinded to group allocation and did not participate in intervention delivery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Student

Model Details: Three-arm parallel randomized controlled trial with a 1:1:1 allocation ratio: routine care (control), routine care plus Kinesio Taping, and routine care plus compression therapy.

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 17, 2026
• Study Start: October 1, 2025
• Primary Completion: September 26, 2026
• Study Completion (Estimated): May 26, 2027
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)