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

NCT07459881 | Not Yet Recruiting

• 1 other identifier: 115023-E
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer Lymphedema

Outcome Measures

Primary Outcomes (4)

• Upper limb circumference point-by-point

  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.

  5 weeks

• shoulder range of motion

  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.

  5 weeks

• Disabilities of the Arm, Shoulder and Hand questionnaire, DASH

  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.

  5weeks

• Functional Assessment of Cancer Therapy-Breast Cancer

  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.

  5 weeks

Study Arms (1)

Combined Upper Extremity Exercise and Pneumatic Compression Therapy

EXPERIMENTAL

Participants will receive a 6-week intervention consisting of structured upper extremity exercise combined with pneumatic compression therapy. Outcomes will be measured at baseline, post-treatment, and one-week follow-up.

Other: Combined Upper Extremity Exercise; Other: Pneumatic Compression Therapy

Interventions

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

Combined Upper Extremity Exercise and Pneumatic Compression Therapy

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

Combined Upper Extremity Exercise and Pneumatic Compression Therapy

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, Taiwan, 220, Taiwan

Location

MeSH Terms

Conditions

Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

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

Central Study Contacts

yung-hsin Lin

CONTACT

+886-2-8966-7000; annielin1212@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, single-arm interventional study using a pretest-posttest design with short-term follow-up. All eligible participants will receive a standardized intervention protocol consisting of structured upper extremity exercise combined with pneumatic compression therapy over a 5-week period. Outcome measures, including limb circumference, shoulder range of motion, DASH score, and FACT-B score, will be evaluated at baseline, immediately after the 12th treatment session, and at one-week post-intervention follow-up. Participants serve as their own controls, and within-subject changes across time points will be analyzed.

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 10, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)