Overview
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.
Description
This is a single-center, three-arm, parallel-group randomized controlled trial conducted at the Department of Breast Surgery, Tangshan People's Hospital (RMYY). A total of 99 female patients with unilateral breast cancer who have undergone breast-conserving surgery, completed radiotherapy for at least 2 months, and developed radiotherapy-related breast lymphedema will be enrolled. Participants will be randomly assigned in a 1:1:1 ratio to one of three groups: (1) routine care (control), (2) routine care plus Kinesio Taping, or (3) routine care plus compression therapy. The intervention period lasts 6 weeks.
Outcome measures include:
Breast skin thickness measured by ultrasound at four quadrants (upper outer, upper inner, lower outer, lower inner), each measured at 35-40 mm from the nipple, with 3 images averaged per location; Lymphedema-related symptoms (pain, swelling, heaviness, tightness) assessed by Visual Analog Scale (VAS), scored 0-10; Breast transverse and vertical diameters measured by cross-measurement method using a non-elastic tape measure; Quality of life assessed by the Functional Assessment of Cancer Therapy-Breast (FACT-B) Chinese version (36 items, 5-point Likert scale, total score 0-144); Self-efficacy assessed by the Breast Cancer Survivors Self-Efficacy Scale (BCSES) Chinese version (11 items, 5-point Likert scale, total score 11-55); Anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS) Chinese version (14 items, 7 for anxiety and 7 for depression).
Assessments will be conducted at baseline (T0), immediately post-intervention at 6 weeks (T1), and at 3 months (T2) and 6 months (T3) post-intervention.
Sample size is 33 participants per group (total 99, including 20% attrition allowance). Randomization will be performed using block randomization with a 1:1:1 allocation ratio. Statistical analysis will follow the intention-to-treat principle. Adverse events will be monitored throughout the study and recorded via follow-up logs and WeChat (a Chinese multi-purpose messaging, social media, and mobile payment app developed by Tencent) platform.
The study protocol has been approved by the Medical Ethics Committee of Tangshan People's Hospital (LLKS) (Approval No. RMYY-LLKS-2025304), and all participants will provide written informed consent before enrollment.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
