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.: PACTR202202585571226 Date of Approval: 15/02/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Peptide supplementation for improving nutritional status of cancer patients
Official scientific title Application of bioactive peptide supplementation for attenuation of malnutrition in cancer patients in a treatment health facility in Ghana
Brief summary describing the background and objectives of the trial Background: Generally, people with cancer are at higher risk of nutrient deficiencies and undernutrition compared with the rest of the population. Thus, malnutrition is prevalent in cancer patients and has been associated with poor therapy responses and unfavorable clinical outcomes. One major cause of undernutrition in cancer patients is that the various treatment methods - surgery, chemotherapy, hormone therapy, immunotherapy, radiotherapy and stem cell transplant increase the body’s energy and protein needs, but at the same time makes it difficult for affected patients to eat adequately well. It has been found that these therapeutic modalities themselves, can cause gut malabsorption and imbalances of metabolism, which can further deteriorate a cancer patient ‘s nutritional status. Therefore, undernutrition in cancer patients impairs their quality of life, therapeutic responses, further leading to poor prognosis of the disease. Recent studies suggest that active peptides isolated from soybean have been proven to have a variety of physiological activities, such as antioxidant, antibacterial, anti-tumor and anti-cancer properties. Aim: Therefore, the study aims to investigate the effectiveness of food-borne (soybean) peptides in reducing malnutrition (muscle mass wasting) and improving overall quality of life among cancer patients in the Oncology Treatment Unit of the Cape Coast Teaching Hospital, Ghana. Method: The study is a Clinical Trial. Cancer patients from the Oncology treatment Unit of the Cape Coast Teaching Hospital, will be recruited and followed for 12 weeks. A signed informed- consent will be obtained from all the 80 cancer patients who will volunteer and give their content to participant in the study. Forty (40) patients with newly diagnosed primary tumors (such as colorectal cancer, breast cancer, gastrointestinal tumor, hematological system tumor, etc.) and 40 patients with newly diagnosed corresponding tumors will be randomly assigned to a control group (chemoradiotherapy group) and an experimental group (peptide + chemoradiotherapy group). Randomization into the various study groups will take into consideration the stage of the cancer infection so that subjects are stage-matched into the groups. To evaluate the effectiveness of the intervention, quantitative and on the Body Mass Index (BMI), assessment of nutritional status (the patient's family members fill in the nutrition scale),weight changes (gains or losses), activities and body functions and overall quality of life will be obtained at baseline and after administration of the intervention. Information on baseline diets of all volunteer patients will be taken. Again, information on dietary intakes of all study participants will be obtained weekly using a Food Frequency Questionnaire. Qualitative data on eating conditions, appetite changes will also be obtained. Safety assessment of the intervention will include adverse events, clinical laboratory examination, and physical examination (including vital signs/body weight). Expected result: The study envisages that administration of the supplement will improve cancer patient’s response to chemotherapy, quality of life, increase their life expectancy and survival rate.
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 01/03/2023
Actual trial start date
Anticipated date of last follow up 30/11/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
Recruitment status Active, not 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 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
Control Group Dietary management Recommended adjustments to diet 16 weeks The control treatment will comprise of dietary recommendations for participants. They will be advised to have small frequent meals which are energy dense and high in protein. They will be made to include foods high in antioxidants and essential micronutrients that boost the immune system 40 Active-Treatment of Control Group
Experimental Group Peptides isolated from soya beans 18 grams of peptides to be dissolved in water to be taken twice daily by participants 16 weeks The interventional supplement is a standardised formulation of peptides isolated from soyabeans. The formulation is packaged into bags with uniform weights and patients are supposed to administer twice a day 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Only those who will meet all of the following criteria will be eligible to be included in the study: 1. Histological confirmation of a newly diagnosed primary tumor 2. Patient BMI < 18 kg/m2; 3. Patients who received conventional radiotherapy or radiotherapy combined with chemotherapy after surgery; 4. Nutritional assessment results before chemotherapy showing malnutrition; 5. ECOG score 0-2; 6. Sign the informed consent voluntarily. Those who meet any of the following criteria shall not be admitted to the study: 1. Frequent vomiting or conditions affecting oral administration (e.g., the patient has intestinal obstruction) 2. Pregnant or lactating women 3. Any other conditions that the investigator considers unsuitable for inclusion in the study, if the subject's compliance is known to be poor Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 25 Year(s) 65 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 08/02/2022 Cape Coast Teaching Hospital ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
CC-071-9967, Pedu Cape Coast 233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The outcomes of interest in this study are an improvement in the quality of life of participants., body mass index and mid upper arm circumference week 0, 8, 16
Secondary Outcome The safety of the supplement, expressed as its effects on hematological, biochemical, urine parameters and inflammatory markers. Related adverse events and tolerability of the product week 0, 8, 16
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Oncology Care Department of the Cape Coast Teaching Hospital cc-071-9967, Abura Pedu Cape Coast Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
South China University of Science and Technology and Chinese Research funding organization 381 Washan Road, Guangzhou City Guangzhou City China
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor South China University of Technology 381 Washan Road, Guangzhou Guangzhou City China University
COLLABORATORS
Name Street address City Postal code Country
Cancer care Unit of the Cape Coast Teaching Hospital Ghana CC 071 9967 Pedu Cape coast Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Christiana Nsiah Asamoah cbuxton@ucc.edu.gh +233249943297 University of Cape Coast
City Postal code Country Position/Affiliation
Cape Coast Ghana Department of Clinical Nutrition and Dietetics University of Cape Coast
Role Name Email Phone Street address
Public Enquiries Jessica Ayensu jessica.ayensu@ucc.edu.gh +233246572635 University of Cape Caost
City Postal code Country Position/Affiliation
Cape Caost Ghana Department of Clinical Nutrition and Dietetics University of Cape Coast
Role Name Email Phone Street address
Scientific Enquiries Ren Jiaoyan jyren@scut.cn 13602421452 381 Wushan Road, Guangzhou City
City Postal code Country Position/Affiliation
Guangzhou City China South China University of Technology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All data collected from participants and used in the final analysis will be available to the public after a process of deidentifying them. The study protocol, consent forms and related data collection tools will be accessible. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will be available 6 months after completion of the trial Individuals with an interest in the data will need to apply to the Ethics committee of the facility. All applications will be reviewed and each application accepted based on its merit to society. Assurances would need to be provided by applicants about non commercial use and third party usage of the information.
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