1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
06 Nov 2022
THE IMPACT OF PROBIOTICS AND POLYUNSATURATED FATTY ACIDS IN ACHIEVING OPTIMUM NUTRITION IN COLORECTAL CANCER PATIENTS: A PRELIMINARY STUDY
Protocol summary
Summary
Background: Treating patients suffering from cancer is often complicated by a variety of major clinical problems.
The dilemma is that they are partly caused by the tumor itself and partly by the anticancer treatment. The combination of progressive physical weakness and fatigue, the psychological stress of the cancer diagnosis, toxicities of therapy, and anorexia can all adversely affect the patient’s quality of life. Hypothesis:
Eicosapentaenoic acid , and probiotics improve quality of life and body composition and decreases chemotherapy- induced toxicity and level of immunomodulating agents in colorectal cancer patients with chemotherapy.
Objective: To evaluate quality of life, body composition and side effect of colorectal cancer patients after chemotherapy. Main inclusion criteria: Patients
histological confirmed colorectal cancer and be recruited prior to chemotherapy after surgery. Main exclusion criteria: Chemotherapy initiation before supplements intervention and Patients with radiotherapy treatment.
Methodology: After tumor staging in colorectal cancer patients and the decision for surgery and palliative chemotherapy by a tumor board and also the detection of pending or clinically evident malnutrition, patients were immediately seen by the nutrition support team. All patients received adjuvant chemotherapy following surgery. They were randomized to two treatment groups.
One (case) will receive oral supplementation and the other (control) will receive placebo making it a blinded study. Intervention: The case group will follow probiotics will take one sachet (3 gram) B-Crobs daily for up to 4 weeks, and omega-3 (Nova) 1.2 g/d for the 8 weeks. We will compare two groups in quality of life, blood analysis (ELISA), chemotherapy side effects, body composition, and dietary intake by using questionnaire (European organization research and treatment of cancer quality of life questionnaire, and Common terminology criteria for
adverse events), and ELASA mrthod before and after intervention. Main outcome: to come out with standard optimization package of nutrients for post-chemotherapy patients. Besides that, we aim to get standard methods to improve quality of life, modulate inflammatory markers level, and reduce chemotherapy side effects
General information
Acronym
IRCT registration information
IRCT registration number: IRCT201106156814N1 Registration date: 2011-07-27, 1390/05/05 Registration timing: registered_while_recruiting
Last update:
Update count: 0 Registration date
2011-07-27, 1390/05/05 Registrant information
Name
Chin Kin Fah
Name of organization / entity university Malaya Medical Centre Country
Malaysia Phone
0060379492677 Email address
[email protected] Recruitment status
Recruitment complete Funding source
Postgraduate Research Grant University Malaya Expected recruitment start date
2011-07-01, 1390/04/10
2 Expected recruitment end date
2012-07-01, 1391/04/11 Actual recruitment start date
empty
Actual recruitment end date empty
Trial completion date empty
Scientific title
THE IMPACT OF PROBIOTICS AND POLYUNSATURATED FATTY ACIDS IN ACHIEVING OPTIMUM NUTRITION IN COLORECTAL CANCER PATIENTS: A PRELIMINARY STUDY Public title
NUTRITIONAL OPTIMISATION WITH SPECIFIC NUTRIENTS IN COLORECTAL CANCER PATIENTS RECEIVING
CHEMOTHERAPY; A CASE CONTROL STUDY, RANDOMIZED CONTROLLED TRIAL
Purpose Prevention
Inclusion/Exclusion criteria
Inclusion criteria Patients must have histological confirmed colorectal cancer; Patients must be recruited prior to chemotherapy after surgery; Patients must have sufficient organ and marrow function so that
chemotherapy treatment can be administered; Ability to understand and the willingness to sign a written informed consent document. Exclusion criteria Patients may be receiving any other investigational agents; There are known allergies associated with supplements;
Uncontrolled intercurrent illness that render the patient ineligible to receive chemotherapy; Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with supplements.
Breastfeeding should also be discontinued if the mother is treated with supplements; Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with supplements; Because no dosing or adverse event data are currently available on the use of glutamine in patients <18 years of age, children are excluded from this study; Chemotherapy initiation before supplements intervention; Patients with radiotherapy treatment;
Patients suffer from anxiety and depression. This will be given to the patient as part of the recruitment process.
Age
No age limit Gender
Both Phase
2
Groups that have been masked No information
Sample size
Target sample size: 140
Randomization (investigator's opinion) Randomized
Randomization description Blinding (investigator's opinion)
Double blinded Blinding description Placebo
Used Assignment
Parallel
Other design features
Secondary Ids
1
Registry name N/A
Secondary trial Id N/A
Registration date empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Ethics Committee University Malaya Medical Centre
Street address
Lembah Pantai, 59100 Kuala Lumpur City
kuala lumpur Postal code
50603 Approval date
2011-01-26, 1389/11/06
Ethics committee reference number 829.8
Health conditions studied
1
Description of health condition studied Colorectal cancer
ICD-10 code C18
ICD-10 code description Malignant neoplasm of colon
2
Description of health condition studied Rectosigmoid cancer
ICD-10 code C19
ICD-10 code description
Malignant neoplasm of rectosigmoid junction
3
3
Description of health condition studied Rectal cancer
ICD-10 code C20
ICD-10 code description Malignant neoplasm of rectum
Primary outcomes
1
Description Quality of life Timepoint
Before starting chemotherapy and supplementationa nd after completion of supplementation and chemotherapy Method of measurement
EORTC QLQ C-30
Secondary outcomes
1
Description
Serum level of IL-6, TNF-α, and CRP Timepoint
before and after supplementation Method of measurement
ELISA
2
Description
Chemotherapy induced toxicity Timepoint
before and after supplementation Method of measurement
Questionnaire (CTCAE)
Intervention groups
1
Description
Fish oil /intervention. 1200mg (providing omega-3 420 mg EPA and 280 mg DHA) 5 times daily for 8 weeks after starting chemotherapy
Category
Treatment - Drugs
2
Description
Probiotics/ intervention. 3 gr Granule contains the following probiotic strains: L.acidophilus, L. lactis, L. casei subsp, L. longum, L. bifidum, L. infantis twice a day for 4 weeks after starting chemotherapy
Category
Treatment - Drugs
3
Description
Sunflower oil /control 1200mg 5 times daily for 8 weeks after starting chemotherapy
Category Placebo
4
Description
Lactose / control 3 gr Granule contains: Lactose, Maltodextrin, Citric Acid, Ascorbic Acid, Skim Milk Powder, and Sugar twice a day for 4 weeks after starting chemotherapy
Category Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center Oncology Clinic
Full name of responsible person dr. Ho
Street address
University malaya medical centre City
Kuala lumpur
Sponsors / Funding sources
1 Sponsor
Name of organization / entity B-CROBES
Full name of responsible person Yee-Chin Mah (Mr)
Street address
31 B, Jalan USJ 10/1E,47620 Subang Jaya,Selangor Darul Ehsan.Malaysia.
City
Kuala lumpur Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source B-CROBES
Proportion provided by this source 100
Public or private sector empty
Domestic or foreign origin empty
Category of foreign source of funding empty
Country of origin
4 Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity University Malaya Medical Centre Full name of responsible person
Dr. Babak. Golkhalkhali Position
PHD Student, Researcher Other areas of specialty/work Street address
Surgery Dept., Medicine Faculty, University Malaya City
Kuala lumpur Province
Kuala lumpur Postal code
50603 Phone
0060379492677 Fax
[email protected] Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity University Malaya Medical Centre Full name of responsible person
Chin Kin Fah Position
Professor
Other areas of specialty/work Street address
Surgery Department., Medicine Faculty, University Malaya
City
Kuala Lumpur Province
Kuala Lumpur Postal code
50603
Phone
0060379492677 Fax
[email protected] Web page address
Person responsible for updating data
Contact
Name of organization / entity University Malaya Medical Centre Full name of responsible person
Babak. Golkhalkhali Position
PHD Student
Other areas of specialty/work Street address
Surgery Department, Medicine Faculty, University Malaya
City
Kuala Lumpur Province
Kuala Lumpur Postal code
50603 Phone
0060379492677 Fax
[email protected] Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD) empty
Study Protocol empty
Statistical Analysis Plan empty
Informed Consent Form empty
Clinical Study Report empty
Analytic Code empty Data Dictionary
empty
