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.: PACTR201807745027158 Date of Approval: 11/07/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title An assessment of the use of metformin in preventing prednisone-induced elevation in blood glucose levels among blood cancer patients at Kenyatta National Hospital
Official scientific title An assessment of the effectiveness of metformin in preventing prednisone-induced hyperglycemia among hematological cancer patients at Kenyatta National Hospital
Brief summary describing the background and objectives of the trial Prednisone is a mainstay in the management of hematological cancers, forming part of the chemotherapy regimen. Unfortunately, its use especially in high doses, is associated with the adverse side effect of hyperglycemia amongst these patients. The study aims to seek the possibility of averting this associative side effect by using metformin,an oral hypoglycemic agent, to prevent this increase in blood glucose, while conferring minimal risk to the patient .It aims to establish whether any comparable differences are observed amongst the patients on metformin(the intervention group)and those without metformin(the control group). The objective is to assess the effectiveness of metformin in the prevention of prednisone-induced hyperglycemia among adult hematological cancer patients receiving high-dose prednisone at Kenyatta National Hospital. Specific objectives include: 1. To determine the incidence of pre-diabetes and diabetes among adult hematological cancer patients receiving prednisone-based regimens with no metformin prophylaxis of prednisone-induced hyperglycemia 2. To assess the effectiveness of Metformin in preventing prednisone-induced hyperglycemia among adult hematological cancer patients receiving high-dose prednisone. 3. To compare the postprandial blood glucose levels achieved by single versus double daily metformin dosing among adult hematological cancer patients receiving high-dose prednisone.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 11/06/2018
Actual trial start date 25/06/2018
Anticipated date of last follow up 20/08/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
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 Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard care The study participants in the control group will receive the ascribed standard care of treatment offered to these patients Each enrolled and consented participant will be followed up for 4 weeks, one specified day per week. The standard care entails the prescribed chemotherapy management for participants' illness as well as any additionally prescribed treatment. This may include proton pump inhibitors for example omeprazole and calcium tablet supplements. These are usually administered to prevent peptic ulcer disease and osteoporosis respectively. 25 Uncontrolled
Experimental Group Glucophage tablets A dose of 850mg once daily for the first two weeks, adjusting upwards to 850mg twice daily for the remaining subsequent two weeks. Each enrolled study participant will be followed up for a duration of 4 weeks, once weekly on a specified day The intervention arm will receive their prescribed chemotherapy, the standard care of treatment prescribed by their physician as well as additional treatment with metformin. Metformin will be initiated at a dose of 850mg once daily for the first two weeks. This will be dispensed as seven tablets, to be taken once daily in the morning with meals. This schedule will allow patient follow up and assessment as well as concomitant refill of metformin tablets upon ensuring participant adherence and compliance. After two weeks, the dose of metformin will be titrated upwards to 850mg twice daily for the next two weeks. This will be dispensed as fourteen tablets, to be taken twice daily in the morning and evening(every 12 hourly) with meals. This schedule will also allow patient follow up and assessment as well as concomitant refill of metformin tablets upon ensuring participant adherence and compliance. 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Patients currently on or are being initiated on high-dose prednisone-based chemotherapy (>30mg/day) with hematological cancers (ALL, NHL, CLL, HL and MM). 2.Patients with postprandial blood glucose readings indicating no hyperglycemia prior to enrollment in the study. 3.Patients aged 18 years and above. 4.Patient having adequate renal function prior to enrollment to the study with a serum creatinine levels of <150umol/L and/or estimated glomerular filtration rate (eGFR) of >30mL/min per 1.73m2. 5.Patients with adequate electrolyte balance particularly serum lactate levels <5 mmol/L. 6.Patients showing willingness to comply with the study protocol and have a signed informed consent. 7.Patients with normal hemoglobin reference values from full hemogram tests. 1.Patients on prednisone treatment for any other indication other than hematological cancers, 2.Patients with pre-existing diagnosed diabetes mellitus, 3.Patients recently exposed or awaiting radiocontrast procedures, patients with recent exposure (less than 3 months) to metformin, 4.Patients with more than one cancer where the additional cancer is non-hematological, 5.Patients on medication that may contribute to hyperglycemia like thiazide diuretics, beta-blockers, protease inhibitors, statins, niacin, phenytoin, atypical anti-psychotics, oral contraceptives and L-asparaginase, 6.Pregnant patients, 7.Patients with significant electrolyte disturbances, 8.Patients with tissue hypoxia like cardiac or respiratory insufficiencies, 9.Patients consuming three or more alcoholic drinks per day, 10.Patients with concurrent severe illness and patients currently on any other antidiabetic therapy. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 08/06/2018 KNH UoN ERC
Ethics Committee Address
Street address City Postal code Country
Along Old Mbagathi Way, Off Ngong Road Nairobi 00202 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome is to compare the effectiveness of metformin in preventing prednisone-induced hyperglycemia among hematological cancer patients on high-dose prednisone chemotherapy at Kenyatta National Hospital Trial end
Secondary Outcome To compare the postprandial blood glucose levels achieved by single versus double daily metformin dosing among adult hematological cancer patients receiving high-dose prednisone. Trial end
Secondary Outcome To determine the incidence of pre-diabetes and diabetes among adult hematological cancer patients receiving prednisone-based regimens with no metformin prophylaxis of prednisone-induced hyperglycemia Trial end
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kenyatta National Hospital Hospital Road, UpperHill Nairobi 00202 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Lucy Ochola Kizingo road Mombasa 80100 Kenya Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Lucy Ochola lucyochola@students.uonbi.ac.ke +254789233372 Kizingo Road
City Postal code Country Position/Affiliation
Mombasa 80100 Kenya Principal Investigator
Role Name Email Phone Street address
Public Enquiries Zipporah A dept-pharmpractice@uonbi.ac.ke +254721888078 Along old mbagathi way, off ngong road
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Secretary of Pharmacy School
Role Name Email Phone Street address
Scientific Enquiries Eric Guantai enguantai@uonbi.ac.ke +254722955883 Along old mbagathi way, off ngong road
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Supervisor
Role Name Email Phone Street address
Scientific Enquiries David Nyamu dgnyamu@gmail.com +254722403671 Along old mbagathi way, off ngong road
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information