Breast Cancer Related LymphedemaNCT07676045
Manual Lymphatic Drainage With Diaphragmatic Breathing Exercises in Post Radical Mastectomy
A study testing Manual Lymphatic Drainage and Diaphragmatic Breathing Exercises in people with Breast Cancer Related Lymphedema, run by University of Lahore at 1 site in Pakistan.
Trial summary
Lymphedema is a persistent and chronic swelling condition that commonly develops after breast cancer surgeries involving axillary lymph node dissection (ALND). This condition causes pain, heaviness, and swelling in the upper limb, which severely limits shoulder mobility and functional performance in daily life tasks. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer Related Lymphedema
- What is being tested?
- Manual Lymphatic Drainage and Diaphragmatic Breathing Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Apr 2026to 10 Oct 2026
- Phase
- Interventional
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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18 to 65 years.
- Patients diagnosed with unilateral upper limb lymphedema secondary to radical mastectomy.
- Patients with stage I or stage II lymphedema.
- Patients who provide written informed consent to participate in the study
Who cannot join
- Patients with bilateral upper limb lymphedema.
- Presence of active, recurrent, or metastatic cancer.
- Acute skin infections or cellulitis in the affected upper extremity.
- Severe cardiac conditions, congestive heart failure, or unstable deep vein thrombosis (DVT).
- Patients who have undergone specialized physical therapy or manual lymphatic drainage for lymphedema within the past 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Lymphedema is a persistent and chronic swelling condition that commonly develops after breast cancer surgeries involving axillary lymph node dissection (ALND). This condition causes pain, heaviness, and swelling in the upper limb, which severely limits shoulder mobility and functional performance in daily life tasks.
While manual lymphatic drainage (MLD) is widely utilized to stimulate lymphatic flow and reduce tissue swelling, the added therapeutic benefit of combining it with deep breathing exercises remains less evaluated. This study is a randomized controlled trial designed to investigate whether combining diaphragmatic breathing exercises with manual lymphatic drainage is more effective than manual lymphatic drainage alone.
The main goals of this study are to determine if this combined intervention provides greater reductions in arm circumference and subjective pain levels while significantly improving upper extremity range of motion and overall functional ability in female patients recovering from a radical mastectomy.
Read the detailed description
Participants who meet the eligibility criteria will be recruited from the University of Lahore Teaching Hospital and affiliated clinical settings. Following informed consent, participants will be randomly assigned to one of two parallel groups using the lottery method to ensure unbiased allocation. The total study duration will span 4 weeks, with clinical outcomes measured at baseline and at the conclusion of the 4th week.
Both groups will first receive a standardized baseline physical therapy program consisting of:
- Transcutaneous Electrical Nerve Stimulation (TENS) applied for 10 minutes.
- Active range of motion (AROM) exercises for the shoulder, elbow, and wrist (10 repetitions each).
- Gentle upper limb muscle stretching (3-5 repetitions with a 10-second hold).
Following the baseline session, the groups will receive their distinct experimental protocols:
- Group A (Control Group): Will receive 25 to 30 minutes of specialized Manual Lymphatic Drainage (MLD). This manual therapy will employ gentle, slow, and rhythmic skin-stretching strokes directed toward functioning, proximal, unaffected lymph nodes to enhance fluid clearance.
- Group B (Experimental Group): Will receive the identical 25 to 30 minutes of MLD, followed immediately by 2 minutes of structured diaphragmatic breathing exercises. Participants will practice controlled deep breathing in a comfortable, semi-reclined position (inhaling through the nose for 4 seconds, allowing the abdomen to rise, followed by exhalation and a 4-second pause before the next breath).
The entire intervention protocol will be conducted 3 times a week for a duration of 4 weeks. Standardized outcome evaluations will monitor changes in limb circumference discrepancy via tape measurements, upper limb functional mobility using a universal goniometer, disability levels using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, and subjective pain levels on the Numeric Pain Rating Scale (NPRS).
- Conditions
- Breast Cancer Related Lymphedema
- Being tested
- Manual Lymphatic Drainage, Diaphragmatic Breathing Exercises
- Keywords
- lymphedema, post-mastectomy, manual lymphatic drainage, diaphragmatic breathing
- Medical subject headings
- Breast Cancer Lymphedema, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Lymphatic DrainageBehavioural
A specialized manual therapy technique involving gentle, slow, rhythmic skin-stretching strokes directed toward functioning, unaffected proximal lymph nodes to stimulate lymphatic flow and reduce upper extremity swelling. Administered for 25 to 30 minutes per session, 3 times a week for 4 weeks.
Diaphragmatic Breathing ExercisesBehavioural
Structured deep breathing exercises performed in a comfortable, semi-reclined position. Participants practice controlled inhalation through the nose for 4 seconds (allowing the abdomen to expand) followed by a controlled exhalation phase and a 4-second pause before the next breath cycle. Administered for 2 minutes immediately following Manual Lymphatic Drainage, 3 times a week for a total duration of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Control Group | Active comparator | This group will receive standard physical therapy management consisting of Transcutaneous Electrical Nerve Stimulation (TENS) for 10 minutes, active range of motion exercises for the upper limb, and gentle muscle stretching, followed by 25 to 30 minutes of specialized Manual Lymphatic Drainage (MLD). Treatment will be administered 3 times a week for a duration of 4 weeks. Receives: Behavioral: Manual Lymphatic Drainage |
| Group B: Experimental Group | Experimental | This group will receive standard baseline physical therapy management consisting of Transcutaneous Electrical Nerve Stimulation (TENS) for 10 minutes, active range of motion exercises for the upper limb, and gentle muscle stretching, followed by 25 to 30 minutes of specialized Manual Lymphatic Drainage (MLD). Immediately following the manual therapy, participants will perform 2 minutes of structured diaphragmatic breathing exercises (controlled deep breathing in a semi-reclined position with a 4-second inhalation, abdominal expansion, and a 4-second exhalation phase). The complete protocol will be administered 3 times a week for a total duration of 4 weeks. Receives: Behavioral: Manual Lymphatic Drainage; Behavioral: Diaphragmatic Breathing Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limb Circumference
Upper limb edema volume will be assessed quantitatively using a sequential tape measurement protocol. Linear measurements of arm circumference will be recorded in centimeters at multiple standardized anatomical landmarks across both the affected and unaffected upper extremities to calculate overall swelling discrepancy.
Measured: Baseline and post-intervention at 4 weeks
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
A 30-item self-report questionnaire designed to measure physical function and symptoms in patients with musculoskeletal disorders of the upper limb. It assesses the patient's capability to perform specific functional activities, symptom severity (such as pain, tingling, and stiffness), and the social/psychological impact on daily life. Score ranges from 0 (no disability) to 100 (severe disability).
Measured: Baseline and post-intervention at 4 weeks
Numeric Pain Rating Scale (NPRS)
A subjective 11-point pain scale where patients rate their current upper extremity pain intensity on a scale from 0 to 10. A score of 0 represents 'no pain' and a score of 10 represents the 'worst possible pain.
Measured: Baseline and post-intervention at 4 weeks
Shoulder Joint Range of Motion
Active range of motion for shoulder flexion, extension, abduction, and internal/external rotation will be measured quantitatively in degrees using a standard universal goniometer to assess upper extremity functional mobility.
Measured: Baseline and post-intervention at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start10 Apr 2026
- Primary completion10 Oct 2026 (estimated)
- Study completion10 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Related 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676045
- Sponsor's protocol ID
- 70094222
- Status last verified
- Apr 2026
- First submitted
- 23 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared outside of the primary research team to maintain patient confidentiality and privacy. The final study results will only be available as aggregated data through the final thesis publication.