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.: PACTR202303721405304 Date of Approval: 20/03/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Traditionally Fermented Micronutrient-Rich Diet (Datta/Qochqocha) Administration to Women with Breast Cancer
Official scientific title Effect of a Traditionally Fermented Micronutrient-Rich Diet (Datta/Qochqocha) on Breast Cancer Chemotherapy Outcome among Women in Ethiopia
Brief summary describing the background and objectives of the trial Cancer is a disease in which abnormal cells multiply and grow uncontrollably (National Cancer Institute, 2021; Shaikh, Krishnan, & Thanki, 2021; Ramahi.et al., 2021). Breast cancer is the most common type of cancer in the world. Cancer disease management is complicated due to the numerous genomic and physiological changes that occur in cancerous tissue constantly and consistently (Sharma et al., 2021). Similarly, chemotherapy outcomes are subpar due to the widespread occurrence of chemo-resistance and its severe side effects such as neutropenia, neuropathy, emotional impact, and gastrointestinal problems (de la Mare et al., 2014; Ma Qin Li, 2020). While chemotherapy is a well-known treatment modality for women with breast cancer in Ethiopia. Micronutrients improve treatment outcomes, reduce the side effects of chemotherapy, and avoid nutritional status degradation in women receiving chemotherapy for breast cancer (Astiazaran-Garcia et al., 2017; Rani et al., 2014; Adamietz.et al., 2016; Mansoor et al., 2021; Nakayama, Alladin, Igbokwe, & White, 2011). There is, however, plenty of evidence confirming the deficiency of micronutrients (Vitamins, Magnesium, Zinc, and other micronutrients) in chemotherapy patients (Dariush Moslemi. et al., 2018; Custódio et al., 2016; Mahjoub. et al., 2020; Salim and Daoud, 2013). In another case, chemotherapy causes gut microbiota dysbiosis, which alters the physiological and psychological function and is linked to inflammation via changes in immune regulation, cytokine expression, and gut barrier function (Deleemans et al., 2019; Reimer. et al., 2020). However, it has been discovered that gut microbiota has multiple beneficial effects on their normal condition, including improving the effectiveness of chemotherapy and preventing the adverse effects of chemotherapy drugs, as well as boosting immunity in breast cancer patients (Jiang, Chen, & Fu, 2020; Laborda-Illanes et al., 2020; Lee et al., 2021). Even though Fermented foods can enhance breast cancer chemotherapy outcomes by enhancing dietary bioactivity, boosting immunity, and reducing the production of cancer-promoting enzymes (Tasdemir & Sanlier, 2020; Dhewa.et al., 2021) it is poorly consumed. Generally, micronutrients, gut microbiota, and fermented foods are observed to have positive health effects in breast cancer chemotherapy individually and they are also interrelated and interdependent; but their common and consistently used effect during chemotherapy is not clear. The goal of this project is to determine the effect of a traditionally fermented micronutrient-rich diet (datta/qochqocha) on breast cancer chemotherapy outcome among women in Ethiopia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/04/2023
Actual trial start date
Anticipated date of last follow up 01/04/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Diet 75gm per day through out chemotherapy period Datta/Qochqocha is the Ethiopian traditionally fermented micronutrient-rich diet(condiment). The community use Datta/Qochqocha claiming that its has the effect of appetizer and treatment effect for some diseases like common cold. 30
Control Group their usual diet their regular amount through out the chemotherapy period Diets that the patients on the chemotherapy patients /house hold/ consume daily. It can be any type of meal that the patient consume except fermented Datta/Qochqocha 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All women with locally advanced breast cancer who planned to be on chemotherapy will be included in both intervention and control groups - Women with breast cancer who also have another known chronic illness - All patients who will be on chemotherapy in combination with radiotherapy and/or hormonal therapy - Under 18 years old females will be excluded from both intervention and control groups. - Patients with metastasized breast cancer 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 80 Year(s) Female
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 08/02/2023 College of Natural and Computational Sciences Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Arada 13/14 Addis Ababa 1176 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome -Stable diseases (ST) -Partial response (PR) -Complete response (CR) -Progressive diseases (PD It will be done on the day of each chemotherapy cycle. While the final outcome will be measured at the completion of chemotherapy
Secondary Outcome status of chemotherapy side effect at each chemotherapy cycle and at the completion of chemotherapy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Black lion specialized hospital Zambia St Addis Ababa Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
St. Pauls Hospital Millennium Medical College Swaziland St Addis Ababa 1271 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor St.Pauls hospital millennium medical college Swaziland St Addis Ababa 1271 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tesfaye Girma Legesse girmanet12@gmail.com +251913227913 Swaziland St
City Postal code Country Position/Affiliation
Addis Ababa 1271 Ethiopia PhD student in Clinical Nutrition at Addis Ababa University
Role Name Email Phone Street address
Public Enquiries Zelalem Debebe zdebebe@yahoo.com +251920032918 4killo King George VI St
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Faculty at Addis Ababa University
Role Name Email Phone Street address
Scientific Enquiries Wondemagegnehu Tigeneh wondemtigenehe@yahoo.com +251911897356 Zambia St
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia oncologist and palliative care physician at Addis Ababa University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results that will be reported as articles, after de-identification, and the study protocol, Statistical Analysis Plan, and Analytic Code will be shared immediately following publication, with no end date. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol A proposal may be submitted up to 24 months following article publication. After 24 months the data will be available in our University’s data warehouse but without investigator support other than deposited metadata. It will be shored to investigators whose will be proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose. It will be used only to achieve aims in the approved proposal and for individual participant meta-analysis.
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