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.: PACTR202104725647601 Date of Approval: 07/04/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Quality of life and outcome in stage IV non-small cells lung cancer patients : A prospective study.
Official scientific title Quality of life and outcome in stage IV lung cancer patients
Brief summary describing the background and objectives of the trial Quality of life is a modifiable factor which may be enhanced by supportive and palliative care procedures in NSCLC patients. correlation between quality of life and outcome in stage IV lung cancer patients is still to prove. The aim of this study was to report precisely the quality of life disturbances in advanced stage lung cancer patients after chemotherapy and assess their correlation to the overall survival.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) lite onset
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/02/2018
Actual trial start date 01/02/2018
Anticipated date of last follow up 31/03/2019
Actual Last follow-up date 31/12/2019
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 71
Recruitment status Completed
Publication URL https://www.hindawi.com/journals/crj/?utm_source=google&utm_medium=cpc&utm_campaign=HDW_MRKT_GBL_SUB_ADWO_PAI_DYNA_JOUR_X&gclid=Cj0KCQiAr8bwBRD4ARIsAHa4YyKGqD2KLQoO7ODo3y2rIFT9ebY2mbZ3C19eHwoA-6g2DGQjxN7NAoEaApW6EALw_wcB
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 Non-randomised Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Vinorelbine plus platinum four cycles of chemotherapy Vinorelbine : 25 mg/m2 of body surface twice a cycle Cisplatin : 75 mg/m2 of body surface /cycle four cycles of chemotherapy last for 63 days investigators propose for our patients to fill auto-questionnaires of assessment of quality of life, sleep quality and humor disturbances after the end of the chemotherapy course. 25
Experimental Group Gemcitabine plus platinum four cycles of chemotherapy Gemcitabine = 1250mg/m2 of body surface twice a cycle Cisplatin = 75 mg/m2 of body surface /cycle 64 days investigators propose for our patients to fill auto-questionnaires of assessment of quality of life, sleep quality and humor disturbances after the end of the chemotherapy course. 25
Control Group Docetaxel plus platinum four cycles Docetaxel 75 mg/m2 of body surface/cycle cisplatin 75 mg/m2 of body surface/cycle 64 days investigators propose for our patients to fill auto-questionnaires of assessment of quality of life, sleep quality and humor disturbances after the end of the chemotherapy course. 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Confirmed NSCLC with histological proof. Written informed consent Other comorbidities associated to NSCLC which interfere with quality of life Anterior sleep disturbance known before lung cancer diagnosis Pharmacological treatment interfering with sleep quality Severe pain with intensity in visual analogical scale (VAS) greater than 6/10, leading to prescription of oral opioïd therapy Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 80 Year(s) Male
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 31/10/2018 comit dthique mdicale de l hopital A Mami
Ethics Committee Address
Street address City Postal code Country
1 rue de lhopital ariana 2080 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome overall survival 31-12-2019
Secondary Outcome response to chemotherapy 3 weeks after chemotherapy end
Secondary Outcome progression free survival 31-12-2019
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
service de pneumologie Pavillon 4 hopital A Mami 1 rue de lhopital ariana 2080 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Nidhal Belloumi 2 rue de lhopital Abderrahmen Mami Ariana 2080 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor service de pneumologie Pavillon 4 no 1 rue de lhopital ariana 2080 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
Pr Imene Bachouch 1 rue de lhopital ARIANA 2080 Tunisia
Pr Chermiti Ben Abdallah Fatma 1 rue de l hopital ARIANA 2080 Tunisia
Dr Habouria Chaima 1 rue de l hopital ARIANA 2080 Tunisia
Pr Soraya Fenniche 1 rue de l hopital ARIANA 2080 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator nidhal belloumi nidhalbelloumi@gmail.com +21620456190 no1 rue de lhopital
City Postal code Country Position/Affiliation
ariana 2080 Tunisia service de pneumologie Pavillon 4
Role Name Email Phone Street address
Scientific Enquiries soraya fenniche soraya.fenniche@rns.tn +21653744966 no1 rue de lhopital
City Postal code Country Position/Affiliation
ariana 2080 Tunisia service de pneumologie Pavillon 4
Role Name Email Phone Street address
Public Enquiries fatma chermiti ben abdallah cherabdallah@yahoo.fr +21670160300 no 0 rue de lhopital
City Postal code Country Position/Affiliation
ariana 2080 Tunisia service de pneumologie Pavillon 4
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes data is available on request to the principal investigator (Email adress= nidhalbelloumi@gmail.com) or online at (https://www.researchgate.net/project/qualite-de-vie-chez-les-patients-porteurs-de-CNPC-au-stade-avance) Clinical Study Report,Statistical Analysis Plan,Study Protocol IPD-sharing time = mid 2021 full access on request to the principal investigator
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.linkedin.com/feed/ Yes 20/03/2021 01/09/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 20/03/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://www.researchgate.net/project/qualite-de-vie-chez-les-patients-porteurs-de-CNPC-au-stade-avance
Changes to trial information