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Breast CancerNCT07767305

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

A study testing Routine Care, Kinesio Taping and Compression Therapy in people with Breast Cancer and Breast Lymphedema, run by Tangshan People's Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Breast Lymphedema
What is being tested?
Routine Care, Kinesio Taping and Compression Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
1 siteChina
Study dates
1 Oct 2025to 26 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Tangshan People's Hospital

    Tangshan, Hebei, 063000

    shuo wang, +86 18168499773, 2624592433@qq.com

    Recruiting

Other trials in China

About this study

Official title: A Randomized Controlled Trial Comparing the Efficacy of Kinesio Taping Versus Compression Therapy on Rehabilitation Outcomes in Breast Cancer Patients With Radiotherapy-Related Breast Lymphedema After Breast-Conserving Surgery

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.

Read the detailed 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.

Being tested
Routine Care, Kinesio Taping, Compression Therapy
Keywords
Kinesio Taping, Compression Therapy, Breast-Conserving Surgery, Breast Lymphedema
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Routine CareOther

    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).

  • Kinesio TapingOther

    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.

  • Compression TherapyOther

    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.

Study groups in NCT07767305
Study groupRoleWhat they receive
Control GroupActive comparatorRoutine care including health education, breast and skin care, lifestyle guidance, and rehabilitation exercises.
Receives: Other: Routine Care
Kinesio Taping GroupExperimentalParticipants 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.
Receives: Other: Kinesio Taping
Compression Therapy GroupExperimentalParticipants 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.
Receives: Other: Compression Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (5)
  1. Ultrasound-Measured Breast Skin Thickness

    Ultrasound measurement of breast skin thickness at four quadrants (upper outer, upper inner, lower outer, lower inner). Each quadrant is measured at 35-40 mm from the nipple, and three images are captured at each location and averaged.

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

  2. Breast Circumference Measures

    Cross-measurement method using a non-elastic tape measure. Transverse diameter (from sternal border to anterior axillary line at nipple level) and vertical diameter (from 4th intercostal space to lower breast border at nipple level) are measured; average diameter calculated. Each location measured twice and averaged.

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

  3. Quality of Life (FACT-B)

    Functional Assessment of Cancer Therapy-Breast (FACT-B) Chinese version. Contains 36 items across 5 domains: physical, social/family, emotional, functional, and additional concerns. Each item scored on a 5-point Likert scale; total score ranges from 0 to 144, with higher scores indicating better quality of life.

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

  4. Self-Efficacy (BCSES)

    Breast Cancer Survivors Self-Efficacy Scale (BCSES) Chinese version. Contains 11 items, each scored on a 5-point Likert scale from 1 (completely lacks confidence) to 5 (very confident); total score ranges from 11 to 55, with higher scores indicating greater self-efficacy.

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

  5. Anxiety and Depression (HADS)

    Hospital Anxiety and Depression Scale (HADS) Chinese version. Contains 14 items: 7 for anxiety and 7 for depression. Each subscale scored: 0-7 = no symptoms, 8-10 = suspected symptoms, 11-21 = definite symptoms. Higher scores indicate greater severity.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2026
  2. Study start1 Oct 2025
  3. Primary completion26 Sep 2026 (estimated)
  4. Study completion26 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
99 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07767305
Sponsor's protocol ID
RMYY- LLKS-2025304
Status last verified
Aug 2026
First submitted
7 Aug 2026
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Routine Care, Kinesio Taping and Compression Therapy in people with Breast Cancer and Breast Lymphedema, run by Tangshan People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lymphedema-Related Symptoms (VAS) (time frame: Baseline (T0), immediately post-intervention at 6 weeks (T1), 3 months post-intervention (T2), and 6 months post-intervention (T3)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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