Lymphedema, Breast CancerCDTNCT07217288
Complete Decongestive Therapy Versus Non-pneumatic Compression Therapy in Post Mastectomy Lymphedema
A study testing Non Pneumatic compression device and Complete Decongestive therapy in people with Lymphedema, Breast Cancer and Mastectomy Related Lymphedema, run by Lahore University of Biological and Applied Sciences at 1 site in Pakistan.
Trial summary
The aim of the study is to compare the effectiveness of Complete Decongestive Therapy and Non-Pneumatic Compression Therapy, both combined with routine physical therapy, in reducing pain and edema volume, improving range of motion, respiratory function, inflammatory markers, and overall quality of life in patients… Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Lymphedema, Breast Cancer, Mastectomy Related Lymphedema, Post Mastectomy Lymphedema
- What is being tested?
- Non Pneumatic compression device and Complete Decongestive therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Feb 2026to 7 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females with age between 30 to 60 years. (Monticciolo et al., 2021)
- Females with unilateral mastectomy post three months of surgery. (Shen et al., 2023) 21
- A volume difference to the circumferential measurements between the affected and unaffected upper extremities of more volume difference>10%.
- Completed chemotherapy and/or radiation therapy. (Borman, Yaman, Yasrebi, İnanlı, \& Dönmez, 2022)
Who cannot join
- Systemic disorders that might contraindicate the use of sequential compression therapy i.e. chronic kidney disease with renal failure, Congestive heart failure, neurological disorders, respiratory disorders.
- Presence of active cellulitis, open and partially healed wounds.
- Patients with lipedema
- Active or recurrent cancer (defined as < 3 months since completion of cancer therapy)
- An acute infection within the previous 4 weeks
- Active venous thromboembolic edema
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- Pregnant women and women who are planning or nursing at study entry.
- Patients who had participated in any clinical trial of an investigational substance or device during the previous 30 days
- Potential patients with a cognitive or physical impairment that would interfere with appropriate use of the device. (Rockson, Whitworth, et al., 2022)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Complete Decongestive-versus Non-pneumattic- Compression Therapy in Patients With Post-mastectomy Lymphedema
The aim of the study is to compare the effectiveness of Complete Decongestive Therapy and Non-Pneumatic Compression Therapy, both combined with routine physical therapy, in reducing pain and edema volume, improving range of motion, respiratory function, inflammatory markers, and overall quality of life in patients with post-mastectomy lymphedema.
Read the detailed description
Post-mastectomy lymphedema (PML) is a chronic, progressive, and disabling complication affecting breast cancer survivors due to disruption of lymphatic drainage following surgery or radiotherapy. It leads to swelling, pain, restricted range of motion, recurrent infections, and reduced quality of life.
Complete Decongestive Therapy (CDT) - a multimodal approach involving manual lymphatic drainage, compression bandaging, skin care, and exercise - is currently the gold standard for lymphedema management. However, CDT is time-consuming, therapist-dependent, and often poorly tolerated or inaccessible for long-term self-management.
Non-Pneumatic Compression Therapy (NPCD) is a newer, portable, and wearable device that provides gradient sequential compression while allowing mobility and daily activity during treatment. It potentially improves adherence, comfort, and patient satisfaction.
Limited comparative research exists evaluating the relative effectiveness of CDT and NPCD in post-mastectomy lymphedema. This study aims to fill this gap and determine which approach produces superior clinical and functional outcomes.
- Being tested
- Non Pneumatic compression device, Complete Decongestive 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.
Non Pneumatic compression deviceDevice
Non-Pneumatic Compression Device (NPCD) is a wearable, portable system providing gradient sequential compression through shape-memory alloy actuators instead of air pressure. Frequency: 5 sessions per week for 8 weeks.
Intensity: Moderate, rhythmic static and dynamic compression applied distally to proximally, allowing safe lymphatic drainage.
Time: 40 minutes per session, once daily.
Complete Decongestive therapyOther
Complete Decongestive Therapy (CDT), is the gold-standard, non-invasive treatment for lymphedema. It combines manual lymphatic drainage (MLD), compression bandaging, exercise therapy, and skin care to reduce limb swelling and improve lymphatic flow.
Frequency: 5 sessions per week for 8 weeks. Intensity: Gentle manual drainage with multilayer compression Time: 60 minutes per session. Type: Therapist-guided manual and compression therapy followed by self-management.
CDT aims to decongest the limb, prevent fibrosis and infection, and enhance mobility and quality of life in post-mastectomy lymphedema patients.
| Study group | Role | What they receive |
|---|---|---|
| Complete Decongestive Therapy (CDT) and Routine Physical Therapy | Active comparator | Group A: Complete Decongestive Therapy (CDT) and Routine Physical Therapy:
Manual Lymphatic Drainage (MLD)
* Duration: 30 minutes/session
* Frequency: 5 days/week
* Technique: Performed by a certified lymphedema therapist
* Areas: Neck, axilla, trunk, and affected limb
* Total treatment time: 8 weeks 2. Compression Bandaging
* Type: Multi-layer short-stretch bandaging
* Application: After MLD in each session
* Worn Duration: 22-23 hours/day
* Reapplied Daily: Yes 3. Skin Care
* Duration: 10 minutes/session
* Components:
* Inspection of skin
* Use of pH-neutral moisturizers
* Infection prevention education 4. Exercise Therapy (Routine Physiotherapy)
* Type: Gentle, active ROM and resistance exercises (e.g., shoulder mobility, grip strengthening)
* Duration: 20 minutes/session
* Progression: Gradually increase intensity over 8 weeks Receives: Other: Complete Decongestive therapy |
| Group B: Non-pneumatic compression device (NPCD) and Routine Physiotherapy (RPT) | Experimental | Subjects will be taught how to apply the device themselves, including placement, duration of use, and turning it on/off. All subjects will be instructed to wear the device for up to 40 minutes per day and to continue their usual activity during use. Routine Physical Therapy:
* Type: Gentle, active ROM and resistance exercises (e.g., shoulder mobility, grip strengthening)
* Duration: 20 minutes/session
* Progression: Gradually increase intensity over 8 weeks Receives: Device: Non Pneumatic compression device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measured by visual analogue scale.
Lymphedema-related symptoms (pain, pressure, heaviness and hardness). The visual analogue scale (VAS) is a validated, subjective measure for acute or chronic pain. Scores are based on self-reported measures of symptoms from 0-10 score. With zero "no pain" and 10 "worst pain". Test-rater reliability has been shown to be good, but higher among literate (r= 0.94, P=0.001) than illetrate patients (r= 0.71, P=0.001).
Measured: Assessment will be done at baseline, 4th week and 8th week.
Secondary outcomes (6)
Edema volume by water displacement method
In the volumetric assessment of lymphedema, the water displacement method involves submerging the affected limb in a water-filled container and measuring the amount of water displaced. The volume change will be determined by subtracting the initial water volume from the final volume after immersing the limb, providing an estimation of limb volume.
Measured: Assessment will be done at baseline, 4th week and 8th week.
Quality of life measured by Lymphoedema Functioning Disability and health questionnaire for the upper limb (Lymph-ICF-UL)
Quality of life will be assessed using Lymphoedema Functioning Disability and health questionnaire for the upper limb (Lymph-ICF-UL). The Lymph-ICF-UL consists of 29 questions. The questionnaire consists of 5 domains: the physical function domain contains 7 questions; the mental function domain contains 4 questions; the household domain contains 4 questions; the mobility domain contains 8 questions; and the life/ social life domain contains 6 questions. Each question has to be scored on an 11-point scale (0 to 10). The anchor points for the physical and mental function domain and household domain are 'not at all' and 'a lot'. Those for the mobility and life domain/ social life domain are 'very well' and 'not at all'. The patient has to score his/ her average problems in functioning (i.e. impairments in function and activity limitations and participation restrictions) due to the upper limb lymphoedema.
Measured: Assessment will be done at baseline, 4th week and 8th week
Functional mobility measured by upper extremity functional index
The Upper Extremity Functional Index used for measuring the functional mobility of patients with breast related lymphedema. The UEF consists of 20 items, each scored on a 5-point Likert scale ranging from: 0 = Extreme difficulty or unable to perform activity, 1 = Quite a bit of difficulty, 2 = Moderate difficulty, 3 = A little bit of difficulty, 4 = No difficulty. The total score ranges from 0 to 80, with higher scores indicating greater functional ability.
Measured: Assessment will be done baseline, 4th week and 8th week
Upper limb range of motion measured by goniometer
The shoulder flexion ROM will be assessed using a 12-inch plastic goniometer. The measurement will be taken with the patient in supine lying with knees flexed, the palm facing medially, and thumbs up. The assessor stood at the side of the affected arm to perform the measurement, with the goniometer axis placed on the middle of the humeral head laterally, the stationary arm parallel with the trunk, and the moveable arm in line with the midline of the humerus. The patient will be instructed to perform flexion (with elevation) of both shoulders to avoid compensatory movement of the affected side. The angle of maximum shoulder flexion measured by the goniometer will be recorded in degrees (°). The intrarater reliability for assessing shoulder flexion ROM using a goniometer has been reported to be excellent (ICC = 0.95, 95% CI = 0.89-0.98)
Measured: Assessment will be done at baseline, after 4th week and 8th week
Respiratory functions measured by spirometer
Spirometric tests will be used as an objective assessment of respiratory functions. Lung capacity and respiratory muscle strength will be assessed according to the criteria of the American Thoracic Society. During the assessment, participants will be asked to sit with their arms crossed, with clips on their noses. Assessments will be conducted with the filter with in the disposable mouth piece. Evaluation of lung capacity will be started with normal breathing, continued with deep inspirations, and ended with a strong and long expiration from the participant. For the first second, the values of forced expiration volume (FEV1) and forced vital capacity (FVC) will be recorded. The best values will be recorded after repeating the assessments three times. For maximal inspiratory pressure (MIP), the nose of the participant will first closed with a clip; after the forced expiration, maximal inspiration will be recorded.
Measured: Assessment will be done baseline, 4th week and 8th week
Inflammatory markers CK, CRP, IL-6, and TNF-α
Venous blood samples will be collected from the non-affected arm by a qualified phlebotomist immediately prior to and after the end of the treatment sessions. Because of risk reduction guidelines (ie, guidelines to minimize injections to the hand and arm), researchers aimed to minimize patient burden by allowing only two blood withdrawals before and after the study. This sampling time point will allow reserachers to determine whether a robust and sustained inflammatory response will be induced by exercises. Samples will be assessed for CK, CRP, IL-6, and TNF-α using standard techniques
Measured: Assessment will be done at baseline, after 4th week and 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2025
- Study start5 Feb 2026
- Primary completion7 Jul 2026
- Study completion7 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphedema, Breast CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahore University of Biological and Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lahore
- Responsible party
- Principal investigator, Sahar Fatima, Lahore University of Biological and Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217288
- Sponsor's protocol ID
- UOL/IREB/25/12/0042
- Other IDs
- U1111-1329-7030
- Acronym
- CDT
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Complete Decongestive-versus Non-pneumattic- Compression Therapy in Patients With Post-mastectomy Lymphedema
- ClinicalTrials.gov ID
- NCT07217288
- Acronym / sponsor ID
- CDT / UOL/IREB/25/12/0042
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Lahore University of Biological and Applied SciencesUniversity, hospital or other
- Collaborators
- University of Lahore
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 7 Jul 2026 (actual)
- Study completion
- 7 Jul 2026 (actual)
- First posted
- 15 Oct 2025 (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.
The aim of the study is to compare the effectiveness of Complete Decongestive Therapy and Non-Pneumatic Compression Therapy, both combined with routine physical therapy, in reducing pain and edema volume, improving range of motion, respiratory function, inflammatory markers, and overall quality of life in patients with post-mastectomy lymphedema.
Detailed description
Post-mastectomy lymphedema (PML) is a chronic, progressive, and disabling complication affecting breast cancer survivors due to disruption of lymphatic drainage following surgery or radiotherapy. It leads to swelling, pain, restricted range of motion, recurrent infections, and reduced quality of life.
Complete Decongestive Therapy (CDT) - a multimodal approach involving manual lymphatic drainage, compression bandaging, skin care, and exercise - is currently the gold standard for lymphedema management. However, CDT is time-consuming, therapist-dependent, and often poorly tolerated or inaccessible for long-term self-management.
Non-Pneumatic Compression Therapy (NPCD) is a newer, portable, and wearable device that provides gradient sequential compression while allowing mobility and daily activity during treatment. It potentially improves adherence, comfort, and patient satisfaction.
Limited comparative research exists evaluating the relative effectiveness of CDT and NPCD in post-mastectomy lymphedema. This study aims to fill this gap and determine which approach produces superior clinical and functional outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complete Decongestive Therapy (CDT) and Routine Physical Therapy | Active comparator | Other: Complete Decongestive therapyGroup A: Complete Decongestive Therapy (CDT) and Routine Physical Therapy: Manual Lymphatic Drainage (MLD) * Duration: 30 minutes/session * Frequency: 5 days/week * Technique: Performed by a certified lymphedema therapist * Areas: Neck, axilla, trunk, and affected limb * Total treatment time: 8 weeks 2. Compression Bandaging * Type: Multi-layer short-stretch bandaging * Application: After MLD in each session * Worn Duration: 22-23 hours/day * Reapplied Daily: Yes 3. Skin Care * Duration: 10 minutes/session * Components: * Inspection of skin * Use of pH-neutral moisturizers * Infection prevention education 4. Exercise Therapy (Routine Physiotherapy) * Type: Gentle, active ROM and resistance exercises (e.g., shoulder mobility, grip strengthening) * Duration: 20 minutes/session * Progression: Gradually increase intensity over 8 weeks |
| Group B: Non-pneumatic compression device (NPCD) and Routine Physiotherapy (RPT) | Experimental | Device: Non Pneumatic compression deviceSubjects will be taught how to apply the device themselves, including placement, duration of use, and turning it on/off. All subjects will be instructed to wear the device for up to 40 minutes per day and to continue their usual activity during use. Routine Physical Therapy: * Type: Gentle, active ROM and resistance exercises (e.g., shoulder mobility, grip strengthening) * Duration: 20 minutes/session * Progression: Gradually increase intensity over 8 weeks |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Females with age between 30 to 60 years. (Monticciolo et al., 2021)
- Females with unilateral mastectomy post three months of surgery. (Shen et al., 2023) 21
- A volume difference to the circumferential measurements between the affected and unaffected upper extremities of more volume difference>10%.
- Completed chemotherapy and/or radiation therapy. (Borman, Yaman, Yasrebi, İnanlı, \& Dönmez, 2022)
Key exclusion criteria (9 listed)
- Systemic disorders that might contraindicate the use of sequential compression therapy i.e. chronic kidney disease with renal failure, Congestive heart failure, neurological disorders, respiratory disorders.
- Presence of active cellulitis, open and partially healed wounds.
- Patients with lipedema
- Active or recurrent cancer (defined as < 3 months since completion of cancer therapy)
- An acute infection within the previous 4 weeks
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 |
|---|---|---|
| Non Pneumatic compression deviceNon-Pneumatic Compression Device (NPCD) is a wearable, portable system providing gradient sequential compression through shape-memory alloy actuators instead of air pressure. Frequency: 5 sessions per week for 8 weeks. Intensity: Moderate, rhythmic static and dynamic compression applied distally to proximally, allowing safe lymphatic drainage. Time: 40 minutes per session, once daily. | Device | Group B: Non-pneumatic compression device (NPCD) and Routine Physiotherapy (RPT) |
| Complete Decongestive therapyComplete Decongestive Therapy (CDT), is the gold-standard, non-invasive treatment for lymphedema. It combines manual lymphatic drainage (MLD), compression bandaging, exercise therapy, and skin care to reduce limb swelling and improve lymphatic flow. Frequency: 5 sessions per week for 8 weeks. Intensity: Gentle manual drainage with multilayer compression Time: 60 minutes per session. Type: Therapist-guided manual and compression therapy followed by self-management. CDT aims to decongest the limb, prevent fibrosis and infection, and enhance mobility and quality of life in post-mastectomy lymphedema patients. | Other | Complete Decongestive Therapy (CDT) and Routine Physical Therapy |
Primary outcome
Pain measured by visual analogue scale.
Time frame: Assessment will be done at baseline, 4th week and 8th week.
Lymphedema-related symptoms (pain, pressure, heaviness and hardness). The visual analogue scale (VAS) is a validated, subjective measure for acute or chronic pain. Scores are based on self-reported measures of symptoms from 0-10 score. With zero "no pain" and 10 "worst pain". Test-rater reliability has been shown to be good, but higher among literate (r= 0.94, P=0.001) than illetrate patients (r= 0.71, P=0.001).
6 secondary outcomes
Edema volume by water displacement method
Time frame: Assessment will be done at baseline, 4th week and 8th week.
Quality of life measured by Lymphoedema Functioning Disability and health questionnaire for the upper limb (Lymph-ICF-UL)
Time frame: Assessment will be done at baseline, 4th week and 8th week
Functional mobility measured by upper extremity functional index
Time frame: Assessment will be done baseline, 4th week and 8th week
Upper limb range of motion measured by goniometer
Time frame: Assessment will be done at baseline, after 4th week and 8th week
Respiratory functions measured by spirometer
Time frame: Assessment will be done baseline, 4th week and 8th week
Inflammatory markers CK, CRP, IL-6, and TNF-α
Time frame: Assessment will be done at baseline, after 4th week and 8th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non Pneumatic compression device and Complete Decongestive therapy in people with Lymphedema, Breast Cancer and Mastectomy Related Lymphedema, run by Lahore University of Biological and Applied Sciences at 1 site in Pakistan.
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 9 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: finished, as of the sponsor's last update on 13 Oct 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain measured by visual analogue scale. (time frame: Assessment will be done at baseline, 4th week and 8th week.). 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 13 Oct 2026.