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.: PACTR201602001488346 Date of Approval: 24/02/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of sodium bicarbonate 8.4% on bronchial carcinoma
Official scientific title Effect of sodium bicarbonate 8.4% on bronchial carcinoma
Brief summary describing the background and objectives of the trial The environmental acidity or pH of living cells and tissues is one of the most important factors that influence molecular processes involved in cell cycle progression, cell proliferation, and differentiation. Also, oncogenesis, malignant transformation, metastasis, and angiogenesis are greatly affected by environmental acidity which also influences the response of cancer cells to various treatments (Song et al., 2006). Matrix metalloproteinases (MMPs) are involved in various processes of cancer progression such as destruction of the basement membrane, entry and exit of tumor cells from the circulation, local migration, and angiogenesis of tumors (Nelson et al., 2000 & Kleiner and Stetler-Stevenson, 1999). In human melanoma models, an acidic pHe increases both migration and invasiveness in vitro, accompanied by MMP-9 activation (Martinez-Zaguilan et al., 1996).This study aims to evaluate the effect of sodium bicarbonate 8.4% on bronchial carcinoma as regard the size of the tumor, histopathological changes, EM changes, MMP-9 expression, cathepsin B level and expression
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Bronchogenic Carcinoma,Cancer,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/02/2016
Actual trial start date
Anticipated date of last follow up 01/07/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status 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 Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intra-tumoral injection of sodium bicarbonate 8.4% via fiberoptic bronchoscopy 25 ml after confirmation of diagnosis, after one week and after 2 weeks 2 weeks injection of 25 ml of sodium bicarbonate 8.4% via fiberoptic bronchoscopy in central bronchogenic carcinoma 30
Experimental Group Inhalation of nebulized sodium bicarbonate 8.4% 5 ml every 6 hours 2 weeks inhalation of sodium bicarbonate 8.4% via nebulizer cup 5 ml/6hours for 2 weeks starting soon after diagnosis of central bronchogenic carcinoma 30
Experimental Group image guided intra-tumoral injection of sodium bicarbonate 8.4% 25 ml after confirmation of diagnosis, after one week and after 2 weeks 2 weeks Image guided transthoracic intra tumoral injection of 25 ml of sodium bicarbonate 8.4% in peripheral bronchogenic carcinoma 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Histologically-diagnosed primary lung cancer either central lung cancer diagnosed with bronchoscopic biopsies or peripheral lung cancer diagnosed with CT or ultrasound ¿ guided biopsies. 2- Patients who are candidates for chemotherapy either because of the cell type as small cell lung cancer or advanced stage non -small cell lung cancer or early stages of lung cancer but not candidates for surgical treatment because of poor cardiopulmonary status or refusal of surgery. Patients with one or more of the following: 1. Pulmonary metastasis from extrathoracic primary tumor. 2. Patients unfit for FOB. 3. Patients who are candidates for surgical resection. 4. Patients who refuse the study 18 Year(s) 70 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 23/01/2016 institutional research board (IRB)
Ethics Committee Address
Street address City Postal code Country
Elgomhoria Mansoura 35511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cathepsin B level and expression 2 weeks after intervention
Primary Outcome histopathological changes 2 weeks after intervention
Primary Outcome electron microscopic changes 2 weeks after intervention
Primary Outcome clinical presentation 2 weeks after intervention
Primary Outcome tumor volume on radiology 2 weeks after intervention
Secondary Outcome Matrix metalloproteinases-9 level and expression 2 weeks after intervention
Secondary Outcome Safety of the procedure through out the intervention period (2 weeks)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
chest department Elgomhoria Mansoura 35511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no funding source
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mohammad Khairy El Badrawy Elgomhoria Mansoura 35511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohammad Khairy El Badrawy Elgomhoria Mansoura 35511 Egypt
Ibrahim El-Dosoky Mohamed Elgomhoria Mansoura 35511 Egypt
Awny Hasan Ibrahim Elgomhoria Mansoura 35511 Egypt
Adel Mohamed Galal Elbadrawy Elgomhoria Mansoura 35511 Egypt
Amal Ahmed Foad Elgomhoria Mansoura 35511 Egypt
Fatma Mohamed Farouk Akl Elgomhoria Mansoura 35511 Egypt
Hala Mohamed Shalaby Samaha Elgomhoria Mansoura 35511 Egypt
Nasef Abdel Salam Rezk Elgomhoria Mansoura 35511 Egypt
Amro Abdelhamid Moawad Elgomhoria Mansoura 35511 Egypt
Azema abdelrahman Elgomhoria Mansoura 35511 Egypt
Taha Taha Abdelgawad Elgomhoria Mansoura 35511 Egypt
Aida Mahmoud Yousef Elgomhoria Mansoura 35511 Egypt
Ibrahim El-Said Abd El-Wahhab Elgomhoria Mansoura 35511 Egypt
Naglaa Mokhtar El Sherbiny Elgomhoria Mansoura 35511 Egypt
Tamer Aly El hadidy Elgomhoria Mansoura 35511 Egypt
Dina Abouelkheir Abdalla Elgomhoria Mansoura 35511 Egypt
Manal Mohamed El-desoky Elgomhoria Mansoura 35511 Egypt
Mohamed Maher El Gamal Elgomhoria Mansoura 35511 Egypt
Manar Ahmed Abdel Rahman Elgomhoria Mansoura 35511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammad Khairy El Badrawy profkhairy2008@yahoo.com 002 01114725911 elgomhoria
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Professor of Chest Medicine- Faculty of Medicine ¿ Mansoura University
Role Name Email Phone Street address
Public Enquiries Dina Abouelkheir Abdalla dkhair@mans.edu.eg 002 01009976012 elgomhoria
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Lecturer of Chest Medicine- Faculty of Medicine ¿ Mansoura University
Role Name Email Phone Street address
Scientific Enquiries Dina Abouelkheir Abdalla dkhair@mans.edu.eg 002 01009976012 elgomhoria
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Lecturer of Chest Medicine- Faculty of Medicine ¿ Mansoura University
REPORTING
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