Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201711002778300 Date of Approval: 18/11/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of low-level laser and complete decongestive therapy in the management of post-breast cancer related lymphedema
Official scientific title A comparison between low-level laser and complete decongestive therapy in the management of post-breast cancer related lymphedema
Brief summary describing the background and objectives of the trial Secondary upper limb lymphedema is a chronic disease that affects patient's quality of life or even a life threatening case. Propose of the study is to compare the effectiveness of low-level laser therapy (LLLT) and Complete Decongestive Therapy (CDT) in the treatment of post-breast cancer related secondary. Methods: 84 female patients with upper limb lymphedema (stage II, III lymphedema according to Foldi classification), age ranged from 45 to 60 years. They will be divided into 3 groups each group 28 patients. Procedures: LLLT group will receive LLLT with the routine traditional program of physical therapy including; cryotherapy, manual massage, and range of motion exercise. CDT Group will received CDT including manual lymph drainage, short stretch bandage, free active exercises and skin care program and the same routine traditional program. Control Group will receive the routine traditional program only. Treatment program will be given with the frequency of 3 sessions per week for 2 months. Round measurements by tape and water displacement by the volumetric will be taken before, and at the end of 2month treatment at three points; wrist joint, elbow joint and at the end of the arm just below the axillary fold.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,post-breast cancer related lymphedema
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 12/12/2017
Actual trial start date
Anticipated date of last follow up 20/03/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 84
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Block randomisation using a randomisation table created by computer sequence generation, with 28 participant in each group Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Low-level laser therapy group (LLLT) three sessions per week for eight consecutive weeks three sessions per week for eight consecutive weeks I- LLLT: A Vectra Genisys Laser (Model 2784, Chattanooga group, Hixson USA) with output Type: Infrared Lamp Laser Class 3B; Pulse Frequencies 8 Hz - 10000 Hz and continuous.Low-level laser therapy (LLLT) Group; will receive LLLT with the routine physical therapy traditional program including; cryotherapy, manual massage, and range of motion exercise. 28
Experimental Group Complete decongestive therapy (CDT) Group three sessions per week for eight consecutive weeks three sessions per week for eight consecutive weeks Complete decongestive therapy (CDT) Group;will receive CDT including manual lymphatic drainage (MLD), short stretch bandage, active resisted exercises and skin care program and the same routine physical therapy traditional program. 28
Control Group Control Group three sessions per week for eight consecutive weeks three sessions per week for eight consecutive weeks Control Group will receive the routine physical therapy traditional program only 28 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- unilateral secondary upper limb post-cancer breast lymphedema 2- Age range from 40 to 60 years. 3- Had undergone radical or modified radical mastectomy with axillary lymph node dissection with or without radiotherapy intervention. 1. Patients with recurrent malignancy, active infection, or clinical evidence of obstructive venous diseases. 2. Patients with bilateral upper limb lymphedema. 3. Patients with Cardiopulmonary disease which decreases the patient activites. 4. Any skin conditions, infection or cuts 40 Year(s) 60 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/09/2017 The Board Council of Higher Education of the School of Physical Therapy, Cairo university
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat traffic - Dokki - Giza, Giza, 11432 Cairo 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Volumetric measurement: a container will be disinfected with boiling water and Dettol between every measurement by the assisting nurse. prior to the first session as baseline measurement and at the end of the 2 month treatment period
Secondary Outcome Circumferential round measurements with tape measurement: From supine lying position with the upper limb relaxed and extended, round measurements using a tape will used to measure the upper limb edema at the following points: the wrist joint, elbow joint, at the end of the arm. prior to the first session as baseline measurement and at the end of the 2 month treatment period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KASR EL AINY hospital 27 Nafezet Sheem El Shafaey St., Kasr el ainy, Cairo. Cairo 11432 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor School of Physical Therapy, Cairo University El-Tahrir st. - in front of Ben El- Sarayat Tra c - Dokki -Giza, Giza, 11432 Cairo 11432 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mary Kamal Nassif Takla El-Tahrir st. - in front of Ben El- Sarayat Tra c - Dokki -Giza, Giza, 11432 Cairo 11432 Egypt
Mary Kamal Nassif Takla El-Tahrir st. - in front of Ben El- Sarayat Tra c - Dokki -Giza, Giza, 11432 Cairo 11432 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mary Takla marynassif@pt.cu.edu.eg 00201222817512 El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki -Giza, Giza, 11432
City Postal code Country Position/Affiliation
Cairo 11432 Egypt Assis Prof
Role Name Email Phone Street address
Public Enquiries Mary Takla marynassif@pt.cu.edu.eg 00201222817512 El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki -Giza, Giza, 11432
City Postal code Country Position/Affiliation
Cairo 11432
Role Name Email Phone Street address
Scientific Enquiries Mary Takla marynassif@pt.cu.edu.eg 00201222817512 El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki -Giza, Giza, 11432
City Postal code Country Position/Affiliation
Cairo 11432 Egypt Assis Prof
REPORTING
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Result URL Hyperlinks
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