Breast Cancer LymphedemaNCT07459881
Effects of Combined Upper Extremity Exercise and Pneumatic Compression Therapy on Breast Cancer-Related Lymphedema
A study testing Combined Upper Extremity Exercise and Pneumatic Compression Therapy in people with Breast Cancer Lymphedema, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Breast Cancer Lymphedema
- What is being tested?
- Combined Upper Extremity Exercise and Pneumatic Compression Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2026to Dec 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 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Far Eastern Memorial Hospital
New Taipei City, Taiwan, 220
yung-hsin lin, +886-2-8966-7000 ext. 2232, annielin1212@gmail.com
About this study
Official title: Effects of Combined Upper Extremity Exercise and Pneumatic Compression Therapy on Breast Cancer-Related Lymphedema: A Prospective Single-Group Pilot Study
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
- Being tested
- Combined Upper Extremity Exercise, Pneumatic Compression Therapy
- Medical subject headings
- Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Upper Extremity ExerciseOther
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 TherapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Combined Upper Extremity Exercise; Other: Pneumatic Compression Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459881
- Sponsor's protocol ID
- 115023-E
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient privacy
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Upper Extremity Exercise and Pneumatic Compression Therapy on Breast Cancer-Related Lymphedema: A Prospective Single-Group Pilot Study
- ClinicalTrials.gov ID
- NCT07459881
- Acronym / sponsor ID
- 115023-E
- Conditions
- Breast Cancer Lymphedema
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Combined Upper Extremity Exercise and Pneumatic Compression Therapy | Experimental | Other: Combined Upper Extremity Exercise, Other: Pneumatic Compression TherapyParticipants 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Upper Extremity ExerciseWarm-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 | Combined Upper Extremity Exercise and Pneumatic Compression Therapy |
| Pneumatic Compression Therapyduration: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 | Other | Combined Upper Extremity Exercise and Pneumatic Compression Therapy |
Primary outcome
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No. Patient privacy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Upper Extremity Exercise and Pneumatic Compression Therapy in people with Breast Cancer Lymphedema, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 4 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: opening soon, as of the sponsor's last update on 10 Mar 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 Taiwan. 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?
Contact yung-hsin Lin (+886-2-8966-7000 ext. 2232, annielin1212@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper limb circumference point-by-point (time frame: 5 weeks). The study lists 4 primary outcomes in all. 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 10 Mar 2026.