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.: PACTR202007730554581 Date of Approval: 01/07/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Rehabilitation for women with breast cancer undergoing ajduvant chemotherapy.
Official scientific title Characterization of muscle fatigue, rehabilitation and quality of life in a population with breast cancer.
Brief summary describing the background and objectives of the trial The aim of this investigation is to study the combined effects of supervised intermittent aerobic training, muscle strength training with electrostimulation and a continuous home-walking program, on cardiorespiratory fitness, muscle function and quality of life of patients with breast cancer during adjuvant chemotherapy period.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 11/05/2016
Actual trial start date
Anticipated date of last follow up 06/07/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 39
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Aerobic and Strength program Six weeks The six-week of supervised progressive aerobic training consisted of an intermittent cycling and home-based walking programs. The muscle strength training program consisted of isometric exercises and Electrical muscle stimulation for the knee extensor muscles. 20
Control Group No intervention Six weeks The Control group maintained taking their adjuvant chemotherapy during the 6-week period without taking part to any exercise or rehabilitation program. 19 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Women aged from 18 to 65 years. - No known history of chronic respiratory, cardiac or neuromuscular disease. - Diagnosed with non-metastatic breast cancer (stage y–IIIA). - Women who have had a mastectomy and are in the process of adjuvant chemotherapy (postoperative). - Hemoglobin concentration < 8 g/dL, platelet count < 20/nL. - Obesity [body mass index (BMI) > 30]. - Malnutrition (BMI < 20). - Treatment with high-dose corticoids (prednisone > 50 mg/day or equivalent dose of related agents). - Chronic infection, neurological or muscular impairment. - chronic diseases that could be exacerbated by exercise (coronary artery disease, chronic obstructive pulmonary disease, osteoarthritis), skeletal metastases resulting in bone instability, or progressive disease Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 05/02/2016 Salah Azaiez Institute Ethics committe ISA
Ethics Committee Address
Street address City Postal code Country
9-Avril 1938 Street TUNIS 1006 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Compared to controls, we mentioned a positive effects of our training protocol on the aerobic fitness and metabolic needs of our trained patients. A significant increases in MViC, ET in an isometric test, and muscle deoxygenating ΔHHb. In addition, we observed an improvement in the myoelectric activity of the Vastus lateralis, characterized by the decrease of the RMS and the increase of the MPF during the holding phase of 50% of the MViC, in the trained group after the six weeks combined aerobic training and muscle strengthening. Finally , we observed a significant improvement in the quality of life of the trained group. This improvement is characterized, on the one hand, by an increase in the overall quality of life and scores at the functional scales, and on the other hand by a reduction in the scores of symptom scales in cancer patients treated with adjuvant chemotherapy Measurements were performed before and after six weeks of training on a trained group, and six weeks apart without any change in physical activity on a control group.
Secondary Outcome Concentration and rating of perceived exertion (RPE), Before and after six weeks of training program. Before and after the six weeks training program
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Salah Azaiez Institute of Cancer 9-Avril 1938 Street TUNIS 1006 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Moadh HIRAOUI Canaris Street Mourouj 2 Tunis Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor APERE Paschal Grousset street AMIENS France University
Secondary Sponsor Salah Azaiez Institute of Cancer 9-Avril 1938 Street TUNIS Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
Amel MEZLINI 9 Avril 1029 Street TUNIS Tunisia
Said AHMAIDI Paschal Grousset street AMIENS France
Pierre Louis Doutrellot Paschal Grousset Street AMIENS France
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator MOADH HIRAOUI moadh.hiraoui@hotmail.fr 0021654369447 Canaris Street Mourouj
City Postal code Country Position/Affiliation
Tunis Tunisia PhD
Role Name Email Phone Street address
Public Enquiries AMEL MEZLINI amel.mezline@rns.tn +21671150792 9-Avril 1938 Street
City Postal code Country Position/Affiliation
TUNIS Tunisia Medical oncology service Director
Role Name Email Phone Street address
Scientific Enquiries SAID AHMAIDI said.ahmaidi@u-picardie.fr +33322827441 Paschal Grousset Street
City Postal code Country Position/Affiliation
AMIENS France APERE Director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes - Cardio respiratory data Study Protocol 2 years - Controlled access - Quality of request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes Compared to controls, a significant increase in the WS (P < 0.01) and the WD (P < 0.01) accompanied by a significant decrease in resting rHR (P < 0.01), exercising HR6' (P < 0.01), [La]b (P < 0.05), HR6'/WS (P < 0.01) and [La]b/WS ratios (P < 0.01) was reported in the trained group. However, a significant decrease both in WD (P < 0.01) and WS (P < 0.01) has been observed in the controls. No significant difference was observed in resting HR, exercising HR6', [La]b, HR6'/WS, and [La]b/WS ratios were observed in the control group. A significant improvement was observed for RPE in training group (P < 0.05). 09/12/2018 20/05/2019
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://www.flipsnack.com/mhir10/protocol-rehabilitation-and-breast-cancer-fdzm43fmz.html
Changes to trial information