Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000027011
Ethics application status
Approved
Date submitted
30/12/2009
Date registered
11/01/2010
Date last updated
11/01/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
lymphedema and laser therapy in women with breast cancer
Scientific title
Treatment of Postmastectomy Lymphedema with Laser Therapy; Double Blind Placebo Control Randomized Study
Secondary ID [1] 1232 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
the effect of low level laser therapy (LLLT) on limb volume, shoulder mobility and hand grip strength in patients with breast cancer related lymphedema 256454 0
Condition category
Condition code
Cardiovascular 256623 256623 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cancer 256652 256652 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fifty-eight women with postmastectomy lymphedema were enrolled in a double-blind, placebo controlled trial. Patients were randomly assigned to active laser (n=28) and placebo (n=26) groups and received irradiation with Ga–As laser over the axillary and arm areas, for 20 mniutes , 3 times a week for 12 weeks. The total energy applied at each point was 300mJoules over 17 points (5.1 Joules in total), giving a dosage of 1.5 Joules/cm2 in the active group. The placebo group received placebo therapy in which the laser had been disabled without affecting its apparent function. Limb circumference, shoulder mobility, and grip strength were measured before treatment and at 4, 8, and 12 weeks, laser therapy applied only on the affected limb not bilateral.
Intervention code [1] 255744 0
Treatment: Other
Comparator / control treatment
The placebo group received placebo therapy in which the laser had been disabled without affecting its apparent function.
Control group
Placebo

Outcomes
Primary outcome [1] 257535 0
Assessment of Lymphedema: Although various methods exist for assessing the quantity and quality of lymphedema, the most commonly used assessment technique involves measuring the circumference of limb at several points along its length. For the arm circumference measurements, subjects lay prone, arms relaxed by their sides and elbows straight. Both arms were measured at each test date. Circumference was measured every 3 cm beginning at the styloid process of the ulna and continuing 45 cm proximally, as well as at the metacarpals and midhand. The measuring tape was placed around the extremity so that there was no slack but also so there was no indentation in the tissue. The sum circumference of the normal side was calculated likewise. The difference between these two was considered as circumference difference.
CL affected - CL normal = CD
CD n -CD0 =TRC
Where:
CL affected Circumference of affected limb for all anatomical points,
CL normal Circumference of normal limb for all anatomical points,
CD Circumference difference of two limbs
CDn Circumference differences at each follow up session,
CD0 Circumference difference at pretreatment session,
TRC Total reduction in circumference
Timepoint [1] 257535 0
lymphedema measurement before treatment , at 4,8,and 12 weeks of tratment
Secondary outcome [1] 262769 0
Assessment of hand grip strength: Grip strength was measured by portable hydraulic hand Jamar dynamometer (Lafayette Instrument 78010 Hand Dynamometer), the measurements were performed while the patients were seated in back chair, with the shoulder adducted, elbow flexed 90 degrees and forearm in neutral rotation. A mean of three trials was calculated, with a 15 second rest in between each of the three contractions
Timepoint [1] 262769 0
measurement before treatment , at 4,8,and 12 weeks of tratment
Secondary outcome [2] 262770 0
Assessment of the Shoulder Mobility: A standard plastic goniometer was used to measure active range of motion (ROM)for shoulder flexion, abduction, and external rotation. For measurement the patient was placed supine with the thorax firmly strapped to the table to prevent body shift, which would tend to compensate for movement of the shoulder.
The use of a goniometer to measure range of movement investigated by, Riddle et al. who concluded that measurements were highly reliable when taken by the same therapist, with reliability between measurers being specific to the range of movement.
For shoulder flexion; the arm were initially relaxed at the side of the body (Neutral position of 0 degree); the arm under test was raised in a sagittal plane from 0 to 180 degree, but affected arm was raised to the limit of pain .
For shoulder abduction; the sound arm was moved away from the side of the body in a coronal plane from 0 to 180 degree, but affected was moved to the limit of pain.
For shoulder external rotation; the arm normal was abducted to 90 degree, and the elbow flexed 90 degree, with forearm in pronation , and the palm facing the feet, but the other arm move according to pain.
Timepoint [2] 262770 0
measurement before treatment , at 4,8,and 12 weeks of tratment

Eligibility
Key inclusion criteria
women with breast cancer related lymphedema (swelling of more than 2cm and less than 8cm of excess limb circumference at each point compared to controlled non operative limb
Minimum age
45 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who had a current metastases , continuing radiotherapy, cellulites, venous thrombosis, chronic inflammatory diseases, history of sever trauma, photosensitivity or who were using any medication that affect body fluid and electrolyte balance were excluded. .Patients with bilateral lymphedema were also excluded because the contralateral normal limb was needed to predicate percentage of lymphedema.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 2379 0
Egypt
State/province [1] 2379 0

Funding & Sponsors
Funding source category [1] 256219 0
Self funded/Unfunded
Name [1] 256219 0
Country [1] 256219 0
Primary sponsor type
Individual
Name
Mohammed Taher Ahmed Omar
Address
Faculty of Physical Therapy ,
Cairo University, ahmed el-zaeat street, 10219
Country
Egypt
Secondary sponsor category [1] 251592 0
Individual
Name [1] 251592 0
Anwer Abd ElGayed
Address [1] 251592 0
Faculty of Physical Therapy ,
Cairo University, ahmed el-zaeat street, 10219
Country [1] 251592 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258318 0
Teaching Hospital Committee on Human Experimentation (Egypt).
Ethics committee address [1] 258318 0
20-el-mataria- Mataria teaching hospital , cairo, Egypt
Ethics committee country [1] 258318 0
Egypt
Date submitted for ethics approval [1] 258318 0
Approval date [1] 258318 0
22/11/2009
Ethics approval number [1] 258318 0
MTHCT20101

Summary
Brief summary
This prospective, double-blind, placebo, controlled randomized, study was conducted to evaluate the effects of low level laser therapy (LLLT) in the management of breast cancer related lymphedema.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30648 0
Address 30648 0
Country 30648 0
Phone 30648 0
Fax 30648 0
Email 30648 0
Contact person for public queries
Name 13895 0
Mohammed Taher Ahmed Omar
Address 13895 0
faculty of physical therapy cairo egypt, 20ahmed elzaed strret
Country 13895 0
Egypt
Phone 13895 0
+966 542115404
Fax 13895 0
Email 13895 0
momarar@ksu.edu.sa
Contact person for scientific queries
Name 4823 0
mohammed taher Ahmed Omar
Address 4823 0
faculty of physical therapy cairo egypt,20Ahmed elzaet
Country 4823 0
Egypt
Phone 4823 0
+966542115404
Fax 4823 0
Email 4823 0
momarar@ksu.edu.sa

No information has been provided regarding IPD availability


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.