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.: PACTR202001818109834 Date of Approval: 22/01/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Resistance Training impact on lean mass and Muscle Strength in Pancreatic Cancer
Official scientific title Resistance Training impact on lean mass and Muscle Strength in Pancreatic Cancer Cachexia: A Randomised Controlled Trial
Brief summary describing the background and objectives of the trial Cachexia is considered a high risk complication in patients with cancer of the pancreas with poor prognosis.This study showed that using resistance training (RT) protocol to increase muscle strength and mass in individuals with cachexia in pancreatic cancer is feasible and effective.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 04/06/2017
Actual trial start date 01/08/2017
Anticipated date of last follow up 08/01/2020
Actual Last follow-up date 08/01/2020
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Resisted Training Program 3 months twice a week. Muscle strength for elbow, knee, and hip flexors and extensors, lean mass and functional performance were measured pre and post period of intervention. 20
Control Group Control Group 3 months No exercise treatment was provided to the traditional care control group. Patients had the opportunity to receive nutritional and psychosocial support. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
resectable or non-resectable PC [stages I–IV]. adults [≥ 20 years of age]. compliance with international guidelines for cancer cachexia diagnosis, including: weight loss over the past 6 months > 5 percent. weight loss > 2 percent in patients with body mass index [BMI] of less than 20 kg / m2, evidence of sarcopenia with a weight loss of more than 2 percent. any musculoskeletal disorders any neurological disorders the hematological capacity was severely impaired, uncontrolled hypertension, heart failure and unknown arrhythmia, severe renal impairment, diminished ability to stand or walk, any other comorbidities that may hinder exercise. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 60 Year(s) Both
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 01/09/2019 Faculty of physical therapy ethical committee for scientific research
Ethics Committee Address
Street address City Postal code Country
Ahmed ELzayat street cairo 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Lean body mass before and after 12 weeks
Primary Outcome muscle strength before and after 12 weeks
Secondary Outcome Physical performance before and after 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Cancer Institute Cairo Kasr Al Eini Street Cairo 11796 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
FatmaAlzahraa H. Kamel Dr Ibrahim Nagy Street Cairo 11241 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor FATMA ALZAHRAA H. KAMEL Dr.Ibrahim Nagy Street Cairi 11241 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Maged A. Basha Shoubra Street Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator FATMA ALZAHRAA KAMEL Dralzahraafatma@gmail.com 00201095277868 Dr.Ibrahim Nagy Street
City Postal code Country Position/Affiliation
Cairo Egypt Assistant Professor
Role Name Email Phone Street address
Scientific Enquiries MAGED BASHA Bashamaged@gmail.com 00201229166889 Yusuf Karam Street
City Postal code Country Position/Affiliation
Cairo Egypt Assistant Professor
Role Name Email Phone Street address
Public Enquiries ASHWAG ALSHARIDAH Ashwagalshrida@gmail.com 0096650701879 King Khalid
City Postal code Country Position/Affiliation
Buraidah Saudi Arabia Assistant Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD that underlie results in the study Study Protocol starting 6 months after publication IPD will be available upon reasonable request by email from the main author after revising the requester qualification relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes A relative short duration of resistant exercises improved considerably lean body mass, muscle strength and functional performance in pancreatic cancer cachexia. The exercise regimen has been well tolerated and should be strongly suggested for these patients as an important support measure to counteract cachexia. 15/10/2020 15/10/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://drive.google.com/open?id=1p_kl1sNWJcHyI_v45DrAY_CH2xUblNtT
Changes to trial information