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Not yet recruiting NCT07459881

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

No phase Interventional Breast Cancer Lymphedema

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Combined Upper Extremity Exercise, Pneumatic Compression Therapy.
Who it may be relevant to
Registry conditions: Breast Cancer Lymphedema. Basic parameters: 20 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
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Official title

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

Overview

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.

Interventions

  • Other Combined Upper Extremity Exercise
    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
  • Other Pneumatic Compression Therapy
    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 outcome measures

  • Upper limb circumference point-by-point [Time frame: 5 weeks]
  • shoulder range of motion [Time frame: 5 weeks]
  • Disabilities of the Arm, Shoulder and Hand questionnaire, DASH [Time frame: 5weeks]
  • Functional Assessment of Cancer Therapy-Breast Cancer [Time frame: 5 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Far Eastern Memorial Hospital — New Taipei City

Identifiers

NCT: NCT07459881 · 115023-E

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗