Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07459881

Effects of Combined Upper Extremity Exercise and Pneumatic Compression Therapy on Breast Cancer-Related Lymphedema

Breast cancer is one of the most common cancers among women worldwide. With advances in treatment, survival rates have steadily increased; however, postoperative complications continue to affect patients' quality of life, with upper extremity lymphedema being among the most prevalent. Breast cancer related lymphedema (BCRL) can result in arm swelling, pain, restricted mobility, and psychological distress, all of which negatively impact daily functioning and social partici pation .

Previous studies have demonstrated that regular and moderate upper extremity exercise does not exacerbate lymphedema; instead, it may improve shoulder mobility, muscular strength, and contribute to edema control. In addition, therapeutic modalities such as pneumatic compression pumps and manual lymphatic drainage have been proven effective in reducing swelling and enhancing patient comfort . Recent systema tic reviews further support the beneficial effects of exercise interventions on upper limb function and quality of life in breast cancer survivors.

Therefore, combining upper extremity exercise with pneumatic compression therapy may re present a promising integrative intervention to improve lymphedema and related functional limitations. This study aims to investigate the effects of such a combined approach on breast cancer patients with lymphedema by comparing outcomes across multiple ti me points, including arm circumference measurements, shoulder range of motion, upper extremity function (DASH), and quality of life (FACT B), with the goal of establishing a more comprehensive rehabilitation model.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Breast Cancer Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female breast cancer patients aged 20-70 years
  • Postoperative unilateral breast cancer surgery with a clinical diagnosis of lymphedema (stage I or II breast cancer treatment, with unilateral lymphedema greater than 2 cm and less than 8 cm at least one measurement point)
  • Completion of subsequent chemotherapy/radiotherapy or other treatments at least 3 months postoperatively
  • Ability to cooperate with 12 treatments and all assessments and sign a consent form

Exclusion criteria

  • Breast cancer with a tendency for recurrence or metastasis
  • Severe infection of the upper limb (cellulitis)
  • Uncontrolled heart failure, deep vein thrombosis (DVT), severe peripheral vascular disease
  • Stage III lymphedema, bilateral lymphedema, or need to take medications that may affect sweat glands in the upper limbs
  • Other musculoskeletal disorders of the upper limbs, joint deformities, or a history of surgery
  • Pregnancy or other conditions unsuitable for participation

Treatment and study plan

Combined Upper Extremity Exercise

Other

Warm-up (5 min): shoulder flexion, abduction, circular motion Active and resistance training (20 min): using elastic bands or 0.5 kg weights： Seated rowing/Chest press/Lat pulldown/Single-arm row/Biceps curl/Triceps extension Two sets of 10 repetitions (or up to 3 sets depending on tolerance) Stretching (5 min): overhead stretch, lateral flexion, biceps/triceps stretch

Pneumatic Compression Therapy

Other

duration:20 minutes Multi-chamber upper limb sleeve Sequential distal-to-proximal inflation Pressure range: 20-40 mmHg (adjusted according to tolerance and safety limits) Monitoring for pain, numbness, pallor, or circulatory compromise

Primary outcomes

  1. Upper limb circumference point-by-point

    Time frame: 5 weeks

    Upper Limb Circumference Measurement

    Upper limb circumference was measured using a non-elastic standard measuring tape at predefined anatomical landmarks to assess limb swelling.

    Measurement Sites:

    Elbow joint

    5 cm, 10 cm, and 15 cm proximal to the elbow

    5 cm, 10 cm, and 15 cm distal to the elbow

    Wrist joint

    Circumference was recorded in centimeters (cm) at each site. Greater circumference values indicate greater limb swelling, while lower values indicate reduction of lymphedema.

    Standardization Procedures:

    All measurements were performed by the same trained assessor.

    Measurements were conducted within the same time window (e.g., 9:00 AM-12:00 PM).

    Participants rested for 10 minutes prior to measurement.

    Measurements were obtained with the participant in the same standardized posture at each assessment time point.

  2. shoulder range of motion

    Time frame: 5 weeks

    Shoulder Range of Motion (ROM) is measured using a standard goniometer to assess active shoulder movements, including flexion, extension, abduction, adduction, internal rotation, and external rotation.

    ROM is measured in degrees (°). Higher values indicate greater joint mobility and better functional movement.

    There is no fixed minimum or maximum score, as normal values vary by movement; however, greater degrees reflect better shoulder function.

  3. Disabilities of the Arm, Shoulder and Hand questionnaire, DASH

    Time frame: 5weeks

    The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a self-reported measure of upper extremity function and symptoms.

    The DASH score ranges from 0 to 100.

    0 indicates no disability (best function).

    100 indicates most severe disability (worst function).

    Higher scores represent worse upper extremity function and greater disability.

  4. Functional Assessment of Cancer Therapy-Breast Cancer

    Time frame: 5 weeks

    The Functional Assessment of Cancer Therapy - Breast (FACT-B) is a validated self-reported questionnaire assessing quality of life in patients with breast cancer. It includes physical, social/family, emotional, functional well-being, and breast cancer-specific concerns.

    The total FACT-B score ranges from 0 to 148.

    Higher scores indicate better quality of life.

    Lower scores indicate poorer quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

yung-hsin Lin

CONTACT

[email protected]

+886-2-8966-7000 ext. 2232

Sponsors and collaborators

Lead sponsor

Far Eastern Memorial Hospital

Other

Registry information

Official study title

Effects of Combined Upper Extremity Exercise and Pneumatic Compression Therapy on Breast Cancer-Related Lymphedema: A Prospective Single-Group Pilot Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.