Article title
Effect of probiotics for the prevention of acute radiation-induced diarrhoea among cervical cancer patients: a randomized double-blind placebo-controlled study
Journal name
Probiotics and Antimicrobial Proteins
Author names, affiliation and email address
- Ye Htut Linn (Corresponding author)
Department of Pharmacology, University of Medicine 1, Yangon. No. 245, Myoma Kyaung Street, Lanmadaw Township, Yangon, Myanmar.
Email address:
Ph: +959977235192
ORCID: 0000-0003-0852-5218
- K Khine Thu
Department of Pharmacology, University of Medicine 1, Yangon. No. 245, Myoma Kyaung Street, Lanmadaw Township, Yangon, Myanmar.
- Nang Hla Hla Win
Department of Pharmacology, University of Medicine 1, Yangon. No. 245, Myoma Kyaung Street, Lanmadaw Township, Yangon, Myanmar.
INFORMED CONSENT FORM FOR THE STUDY
Effect of probiotic for the prevention of acute radiation-induced diarrhoea among cervical cancer patients
INFORMED CONSENT FORM
A. Information Sheet
- Title of Research
Effect of probiotics for the prevention of acute radiation-induced diarrhoea among cervical cancer patients
- Principle Investigator
Dr. Ye Htut Linn
PG Demonstrator at Department of Pharmacology, University of Medicine 1, Yangon, Myanmar
- Organization
University of Medicine 1, Yangon, Myanmar
- Introduction
This is the research to find out whether a probiotic containing live Lactobacillus acidophilus LA-5 plus Bifidobacterium BB-12 can reduce the incidence or the severity of acute radiation-induced diarrhoea in locally advanced cervical cancer patients.
- Purpose of study
The purpose of the study is to find out and compare the incidence and severity of acute radiation-induced diarrhoea in both probiotic and placebo groups and to describe the ECOG performance changes in both probiotic and placebo groups.
- Type of research
Randomized, double-blind, placebo-controlled study
- Recruitment and selection of subjects
Patients will be recruited from the Department of Radiotherapy, Yangon General Hospital (YGH). Patients who are more than 18 years of age with the squamous cell carcinoma of cervix (FIGO staging – I B and above) who has plan to receive external beam whole pelvic radiotherapy with or without concurrent chemotherapy will be selected.
- Research procedures
The patient will be recruited from the Department of Radiotherapy, Yangon General Hospital (YGH). The patients must be the cervical cancer patients with FIGO staging I B and above who will undergo external beam pelvic radiotherapy with the standard dose of 45-50 Gy with or without concurrent chemotherapy. The patients must be above 18 years of age with ECOG performance status 0-2. They will be given standard radiotherapy of 5 fractions per week for 5 weeks.
After selecting with the inclusion and exclusion criteria, informed consent will be taken prior to the study. The consented patients will be allocated into the probiotic or placebo groups by Block randomization.
The probiotic group will be given one capsule three times daily (each capsule contains: Functional yogurt 300 mg containing 1.75 billion lyophilized live Lactobacillus acidophilus, LA-5 and Bifidobacterium, BB-12), beginning from the first day of radiotherapy, continuing every day until the end of radiotherapy.
The placebo group will receive the placebo capsules (containing starch of equal weight as the study drug) which have identical colour and size as the study drug. The treatment schedule will be the same as the study group. Pre-packaged probiotic medication and placebo will be blinded. Neither the patients nor the treating physician will know if the patient was on the study drug or placebo. The patient will be required to return their drug bottles weekly and the number of capsules returned was documented to check the compliance. Patient who take less than 80% of drugs will be considered as noncompliance.
The patients will allow to take rescue/antidiarrhoeal medication – Loperamide 2 mg if the diarrhoea occur more than three times with severe crumping and they will need to note the time and use of this medication.
- Duration of study
The study lasts for about 8 weeks. 5 weeks during and 3 weeks after radiotherapy.
- Adverse effects
Probiotics are apparently harmless. There was some reports stating sepsis in immunocompromised patients, infective endocarditis in patients with structural heart diseases and those with prosthetic heart valves and some minor GI complaints.
- Potential benefits of the study
The findings of this study will give some valuable information for the radiotherapy management of cervical cancer patients and this can, to some extent, improve the quality of lives of radiation therapy recipients in their post treatment era.
- Benefits of the participants/ Incentives
The participant will have the advantage of reduction of the incidence or the severity of radiation-induced diarrhoea and she will get the health benefits of probiotic consumption. Whether money or other forms of materials goods will be provided in return for the individual’s participation.
- The result of the study
The probiotic containing live Lactobacillus acidophilus LA-5 plus Bifidobacterium BB-12 can reduce the incidence or the severity of acute radiation-induced diarrhoea in locally advanced cervical cancer patients.
- Confidentiality
The patients’ personal data and results will be kept confidential.
- Sharing the results
The results of this research will be used only for the academic purposes (in thesis or publications) without divulging the names or personal details of the patients.
- Right to refuse and withdraw
The participant has the right to refuse to participate and withdraw from the research at any time without affecting further medical care and without penalty or loss of benefits to which they would otherwise be entitled.
- Compensations
No compensation will be provided for participation in this study because participation is totally voluntary.
- Contact of researcher
Dr. Ye Htut Linn
PG Demonstrator at Department of Pharmacology, University of Medicine (1), Yangon, Myanmar.
Ph: 09977235192, 0973017551