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.: PACTR202405488763956 Date of Approval: 15/05/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Lycopene on prostate cancer among native African patients : an open label Randomised clinical trial in KCMC and Ocean road cancer institute ,Tanzania
Official scientific title Effect of Lycopene on prostate cancer among native African patients : an open label Randomised clinical trial in KCMC and Ocean road cancer institute ,Tanzania
Brief summary describing the background and objectives of the trial Prostate cancer is a common disease in elderly men, and second most common cause of death in men, treatment of prostate cancer pauses alot of challenges because its multifactorial.We came up with an idea of studying prevention and /or slow in progression of prostate cancer using lycopene from tomato paste. the main objective is,To determine the efficacy of lycopene from tomato extracts on reduction of Prostate Specific Antigen levels, diseases progression and apoptosis in prostate gland among prostate cancer patients in KCMC and Ocean Road Cancer Institute.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 08/03/2023
Actual trial start date 15/03/2023
Anticipated date of last follow up 15/03/2024
Actual Last follow-up date 15/03/2025
Anticipated target sample size (number of participants) 400
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
2567 Kilimanjaro Christian Medical University college
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 Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group lycopene from tomato paste Patients with confirmed prostate cancer with PSA above 4ng/ml, are enrolled in the study. these patients will carry on with their current treatments , in addition to their standard treatment a sachet of 60grams of tomato paste is added to them that they eat daily. they can mix with food or eat it plain.After 3months following consumption of tomato paste, 5mls of blood will be removed from them to measure PSA and serum lycopene to assess any change in values from the baseline reading. 6months the same tests will be done at one year, PSA and serum lycopene is measured again, in addition trucut biopsy is repeated to assess apoptosis.the one year follow up is post intenvention. one year the control group will continue with standard of care no tomato paste will be given to them 200
Control Group Standard of care routine standard treatment as per schedules one year prostate cancer patients on control arm will maintain their standard to care treatment , no intervention will be added 200 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Prostate cancer patients. PSA above 4 ng/ml. Histological diagnosis. Above 50 years. Allergic to tomato product. Gastrointestinal disease that can interfere with absorption of tomato paste. Middle Aged: 45 Year(s)-64 Year(s) 50 Year(s) 85 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 10/05/2022 Kilimanjaro christian medical university college
Ethics Committee Address
Street address City Postal code Country
lunguo MOSHI 3010 United Republic of Tanzania
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 26/10/2023 National institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
3Barack Obama Drive Dar es salam 255 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Reduction in PSA ONE YEAR post intervention
Secondary Outcome Apoptosis improvement in Prostate gland one year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
kilimajaro christian medical centre KCMC LUNGUO MOSHI 255 United Republic of Tanzania
OCEAN ROAD CANCER INSTITUTE CHIMARA STREET DAR ES SALAM 255 United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Government OF Uganda nakasero kampala 256 Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor BLANDINA MMBAGA LUNGUO MOSHI 255 United Republic of Tanzania University
COLLABORATORS
Name Street address City Postal code Country
Louis Pisters texas street Texas 73301 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator HOPE KIBANSHA MATUMAINI hopemulinga@gmail.com +256782037666 lunguo
City Postal code Country Position/Affiliation
MOSHI 255 United Republic of Tanzania PhD student
Role Name Email Phone Street address
Scientific Enquiries Blandina Mmbaga blaymt@gmail.com +255768435116 lunguo
City Postal code Country Position/Affiliation
Moshi 255 United Republic of Tanzania Director kilimanjaro clinical research institute
Role Name Email Phone Street address
Public Enquiries Mfinanga Sayoki gsmfinanga@yahoo.com +255784755632 dar street
City Postal code Country Position/Affiliation
Dar es salam 255 United Republic of Tanzania National institute for medical researchTanzania
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual al participant data will share de-identified individual participants to insure confidentiality ,names and hospital numbers will not be exposed to avoid easy identification . Study Protocol after 6months of end of study internet and library
URL Results Available Results Summary Result Posting Date First Journal Publication Date
.tz. 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