Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000897460p
Ethics application status
Submitted, not yet approved
Date submitted
23/06/2025
Date registered
18/08/2025
Date last updated
18/08/2025
Date data sharing statement initially provided
18/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Limb circumference, muscle strength and quality of life after Complete Decongestive Therapy with structured exercise among Breast cancer-related lymphedema patient
Scientific title
Limb Circumference, Muscle Strength and Quality of Life after Complete Decongestive Therapy with Structured Exercise Among Breast Cancer Related Lymphedema Patients
Secondary ID [1] 314470 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer 337507 0
Condition category
Condition code
Cardiovascular 333875 333875 0 0
Diseases of the vasculature and circulation including the lymphatic system
Physical Medicine / Rehabilitation 334533 334533 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
a. A brief description of CDT component:
Manual lymphatic Drainage (MLD) - Non-invasive massage technique that uses light, superficial and gentle strokes to mobilize oedema fluid with pumping, scooping, and rotary movement according to Vodder Technique

Multilayer Compression bandaging - Multi-layered padding and short-stretch bandages are applied to the affected limb.

Remedial exercise: includes active, rhythmic, repetitive, non-resistance exercises combined with breathing. These exercises consisted of diaphragmatic breathing exercise, active free exercise for shoulder movement, elbow movement, wrist and fingers.

Skin Care and education
1. Understanding of breast cancer-related lymphedema - sign and symptom
2. Overview of CDT
3. Compression bandaging - how to wear, important of bandaging and care tips
4. Skin care and infection prevention
5. Self-management technique
6. Precaution measure in daily life

The structured exercise is according to a study done by Corum et. al (2021), Omar et al (2019) and Kim et al (2010). Strengthening exercise while wearing a multilayer bandage.

Repetition
Intensity: 60% of their estimated one repetition maximum (1RM) with 3 set per day for each exercise
Resistance exercise includes:
• Triceps extension
• Biceps curl up
• Dumbbell floor fly
• Dumbbell side raise
• Lifting the arm forward
• Wrist curl
• Reverse wrist curl

b) Intervention will be deliver by physiotherapist at the hospital involved

c) Frequency and total duration of intervention:
- weekly for 8 weeks, 60-90 minutes per participants

d) mode of delivery: one to one

e) strategies to assess adherence to the intervention: session attendance and log book
Intervention code [1] 331105 0
Rehabilitation
Intervention code [2] 331531 0
Treatment: Other
Comparator / control treatment
Manual lymphatic Drainage (MLD) - Non-invasive massage technique that uses light, superficial and gentle strokes to mobilize oedema fluid with pumping, scooping, and rotary movement according to Vodder Technique

Multilayer Compression bandaging - Multi-layered padding and short-stretch bandages are applied to the affected limb.

Remedial exercise: includes active, rhythmic, repetitive, non-resistance exercises combined with breathing. These exercises consisted of diaphragmatic breathing exercise, active free exercise for shoulder movement, elbow movement, wrist and fingers.

Skin Care and education
1. Understanding of breast cancer-related lymphedema - sign and symptom
2. Overview of CDT
3. Compression bandaging - how to wear, important of bandaging and care tips
4. Skin care and infection prevention
5. Self-management technique
6. Precaution measure in daily life

Difference between intervention group and control group:
- Intervention group: CDT and structured exercise
- Control group: CDT only
Control group
Active

Outcomes
Primary outcome [1] 341529 0
Limb circumference
Timepoint [1] 341529 0
Baseline, 4th week (primary timepoint), 8th week post intervention
Primary outcome [2] 342209 0
Limb volume
Timepoint [2] 342209 0
Baseline, 4th week (primary timepoint), 8th week post intervention
Secondary outcome [1] 447845 0
Qualiy of life
Timepoint [1] 447845 0
Baseline, 4th week, 8th week post intervention
Secondary outcome [2] 451074 0
Muscle strength
Timepoint [2] 451074 0
Baseline, 4th week, 8th week post intervention

Eligibility
Key inclusion criteria
Participants' diagnosed with breast cancer related lymphedema (Stage 1 & 2) after breast cancer surgery, circumference difference of more than 2 cm between extremities
Minimum age
18 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
a. bilateral upper extremities lymphedema
b. presence of active cancer
c. skin infection or radiotherapy burn in the affected extremity
d. renal failure
e. advanced heart failure
f. participants in other fitness programs
g. recurrent BC during treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomization with variable duration of developing lymphedema and stage of lymphedema according to International Society of Lymphology Staging (ISL) will be used to control the confounding factors in this study. Participants will be stratified by duration of lymphedema into 2 sub-group (less than 2 years and more than 2 years) and lymphedema stages (Stage I and II). The first 5 participants in each stratum will be equally allocated in experimental group and control group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2025
Actual
Date of last participant enrolment
Anticipated
7/05/2026
Actual
Date of last data collection
Anticipated
17/07/2026
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 27074 0
Malaysia
State/province [1] 27074 0

Funding & Sponsors
Funding source category [1] 319007 0
Self funded/Unfunded
Name [1] 319007 0
Country [1] 319007 0
Primary sponsor type
University
Name
University Kebangsaan Malaysia
Address
Country
Malaysia
Secondary sponsor category [1] 321473 0
None
Name [1] 321473 0
Address [1] 321473 0
Country [1] 321473 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317620 0
Research Ethics Committee (REC) University Kebangsaan Malaysia
Ethics committee address [1] 317620 0
Ethics committee country [1] 317620 0
Malaysia
Date submitted for ethics approval [1] 317620 0
07/05/2025
Approval date [1] 317620 0
Ethics approval number [1] 317620 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141590 0
Dr Asfarina Zanudin
Address 141590 0
Universiti Kebangsaan Malaysia Fakulti Sains Kesihatan Kampus Kuala Lumpur, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur
Country 141590 0
Malaysia
Phone 141590 0
+60392897263
Fax 141590 0
Email 141590 0
[email protected]
Contact person for public queries
Name 141591 0
Zaidatul Akma Mat
Address 141591 0
Universiti Kebangsaan Malaysia Fakulti Sains Kesihatan Kampus Kuala Lumpur, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur
Country 141591 0
Malaysia
Phone 141591 0
+60125097296
Fax 141591 0
Email 141591 0
[email protected]
Contact person for scientific queries
Name 141592 0
Zaidatul Akma Mat
Address 141592 0
Universiti Kebangsaan Malaysia Fakulti Sains Kesihatan Kampus Kuala Lumpur, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur
Country 141592 0
Malaysia
Phone 141592 0
+60125097296
Fax 141592 0
Email 141592 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.