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.: PACTR201707002355147 Date of Approval: 14/06/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of Intra-Tympanic Dexamethasone on prevention of Ototoxicity in patients on Cisplatin therapy
Official scientific title Efficacy of Intra-Tympanic Dexamethasone on prevention of Ototoxicity in patients on Cisplatin therapy
Brief summary describing the background and objectives of the trial Cisplatin is a common drug used in the treatment of solid cancers but it has significant side effects which may impair quality of life and interrupt the chemotherapy. The formation of DNA adducts and production of reactive oxygen species by cisplatin causes a permanent injury in the inner ear. The hearing loss is usually permanent and bilaterally symmetrical but there is considerable inter-individual variability. Intra-tympanic administration of steroids offers protection against cisplatin ototoxicity, however the pattern and prevalence of cisplatin ototoxicity in Africans have not been adequately explored, nor has any local trials of intra-tympanic dexamethasone (ITD) and cisplatin ototoxicity been conducted. The goal of this study is to determine the oto-protective efficacy of intra-tympanic dexamethasone in a cohort of Nigerians receiving cisplatin chemotherapy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,Ear, Nose and Throat,Ototoxicity, Solid Cancers
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 19/06/2017
Actual trial start date 19/06/2017
Anticipated date of last follow up 29/06/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
UI/EC/16/0363 UI/UCH ETHICS COMMITTEE
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 Using a computer generated table of random numbers one ear of the patient will be randomly chosen as the intervention ear and the other ear will be the control ear, this assignment will be maintained throughout the study. Open label Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dexamethasone 0.7 to 1ml Once before each dose of Cisplatin Before the commencement of each dosage of cisplatin intra-tympanic Dexamethasone will be administered to the intervention ear under local anesthesia 115
Control Group Nothing Nothing Nothing The ears in the control group will not receive anything 115
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with solid cancers on cisplatin based chemotherapy 1. Severely ill patients who cannot undergo the hearing examination. 2. Pathological findings on otoscopy that do not allow safe ITD delivery 3. Previous inner ear disease with resultant sensorineural hearing loss 4. Conductive hearing loss >5 dBHL 5. Pure tone thresholds average (PTA) >40 dBHL for the frequencies 500 to 3000 Hz or 4000 to 8000 Hz16 6. Asymmetry of PTA between the ears >10 dBHL for the frequencies 500 to 3000 Hz or 4000 to 8000 Hz16 7. Previous treatment with Cisplatin 8. History of radiation therapy (or planned concurrent radiation therapy) to the head and neck regions. 18 Year(s) 90 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 08/12/2016 UI/UCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
INSTITUTE FOR ADVANCED MEDICAL RESEARCH AND TRAINING, COLLEGE OF MEDICINE, UNIVERSITY OF IBADAN IBADAN 200001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pure tone audiometry result Baseline A week after the cumulative dosage of Cisplatin had reached at least 400 mg
Secondary Outcome Pattern of hearing loss secondary to Cisplatin ototoxicity A week after the cumulative dosage of Cisplatin had reached at least 400 mg
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University College Hospital Queen Elizabeth Road Ibadan 200001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
COLLEGE RESEARCH AND INNOVATION MANAGEMENT UNIT COLLEGE OF MEDICINE, UNIVERSITY OF IBADAN IBADAN 200001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor COLLEGE OF MEDICINE UNIVERSITY OF IBADAN IBADAN 200001 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Dr A.A. Adeyemo Institute of Child Health, College of Medicine, University of Ibadan IBADAN 200001 Nigeria
Dr A.M. Folasire Department of Radiotherapy College of Medicine, University of Ibadan IBADAN 200001 Nigeria
Dr B. Adedokun Department of Epidemiology and Medical Statistics, College of Medicine, University of Ibadan IBADAN 200001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adebolajo Adeyemo aadeyemo@com.ui.edu.ng +2348037172329 Institute of Child Health, College of Medicine, University of Ibadan
City Postal code Country Position/Affiliation
IBADAN 200001 Nigeria SENIOR MEDICAL RESEARCH FELLOW/ENT SURGEON
Role Name Email Phone Street address
Public Enquiries AYORINDE FOLASIRE ayofolayemisi@yahoo.com +2348028879622 Department of Radiotherapy College of Medicine, University of Ibadan
City Postal code Country Position/Affiliation
IBADAN 20001 Nigeria LECTURER/RADIATION ONCOLOGIST
Role Name Email Phone Street address
Scientific Enquiries Adebolajo Adeyemo aadeyemo@com.ui.edu.ng +2348037172329 Institute of Child Health, College of Medicine, University of Ibadan
City Postal code Country Position/Affiliation
IBADAN 200001 Nigeria SENIOR MEDICAL RESEARCH FELLOW/ENT SURGEON
REPORTING
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