EFFECT OF PROBIOTICS FOR THE PREVENTION OF ACUTE RADIATION-INDUCED DIARRHOEA AMONG CERVICAL CANCER PATIENTS

• Register: TCTR
• Last refreshed on: 29 April 2024
• Main ID: TCTR20170314001
• Date of registration: 14/03/2017
• Prospective Registration: No
• Primary sponsor: Self funded
• Public title: EFFECT OF PROBIOTICS FOR THE PREVENTION OF ACUTE RADIATION-INDUCED DIARRHOEA AMONG CERVICAL CANCER PATIENTS
• Scientific title: Effect of probiotics for the prevention of acute radiation-induced diarrhoea among cervical cancer patients: a randomized double-blind placebo-controlled study
• Date of first enrolment: 02/05/2016
• Recruitment status: Completed
• URL: https://www.thaiclinicaltrials.org/show/TCTR20170314001
• Study type: Interventional
• Study design: Randomized
• Phase: Phase 2

Countries of recruitment

Myanmar

Contacts

• Name: Ye Htut Linn
• Affiliation: Department of Pharmacology, University of Medicine 1, Yangon

• Name: Ye Htut Linn
• Affiliation: Department of Pharmacology, University of Medicine 1, Yangon

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients with the cervical cancer (FIGO staging – I B and above) who will receive external beam radiotherapy for a minimum of 40 Gy at pelvis level with or without concurrent chemotherapy
2. Age – above 18 years
3. Patients with the ECOG performance status (0-2)
Exclusion criteria: 1. Patients with the previous history of pelvic radiotherapy
2. Patients with the history of intestinal resection
3. Patients with the medical history of irritable bowel syndrome, malabsorption syndrome, inflammatory bowel disease and ileostomy
4. Patients with the history of daily use of antidiarrhoeal medication before radiotherapy
5. Patients with diarrhoea at the beginning of study
6. Patients with immunosuppression (HIV positive, immunosuppressive drugs)
7. Patients with structural heart diseases and those with prosthetic heart valves

Age minimum: 18 Years
Age maximum: 0 N/A (No limit)
Gender: Female

Health Condition(s) or Problem(s) studied

Probiotics, Lactobacillus acidophilus, Bifidobacterium animalis subsp. Lactis, Radiation-induced diarrhoea, cervical cancer

Radiation-induced diarrhoea
Probiotics, Lactobacillus acidophilus, Bifidobacterium animalis subsp. Lactis, Radiation-induced diarrhoea, cervical cancer

Intervention(s)

Active Comparator Other,Placebo Comparator No treatment

Biogurt ® - each capsule contains: Functional yogurt 300 mg containing 1.75 billion lyophilized live Lactobacillus acidophilus LA-5 plus Bifidobacterium animalis subsp. lactis BB-12 (produced by Fame Pharmaceuticals, Myanmar, Reg No. - TMR 011383 (0615), MFD - April, 2016, EXP - April, 2018)

The probiotic group was given one capsule three times daily (each capsule contains: Functional yogurt 300 mg containing 1.75 billion lyophilized live Lactobacillus acidophilus LA-5 plus Bifidobacterium animalis subsp. lactis BB-12), beginning from the first day of radiotherapy, continuing every day until the end of radiotherapy. ,The placebo group received the placebo capsules (containing starch of equal weight as the study drug) which had identical colour and size as the study drug. The treatment schedule was the same as that of the study group.

probiotic group,placebo group

Primary Outcome(s)

incidence of radiation-induced diarrhoea assessed everyday with face-to-face interview percentage,Severity of the radiation-induced diarrhoea – by Common Terminology Criteria for Adverse Events (C daily Grades – face-to-face interview

Secondary Outcome(s)

Onset of radiation-induced diarrhoea daily Days/Gray face-to-face interview,The use of the antidiarrhoeal medication – loperamide daily percentage, face-to-face interview, ,Dose of Loperamide daily mg, face-to-face interview, ,The time to the use of loperamide from the start of radiation daily days, face-to-face interview, ,Severity of abdominal pain – (CTCAE Version 4.0) daily grades, face-to-face interview,Episode of abdominal pain in days daily days, face-to-face interview, ,Interruption of radiotherapy due to diarrhoea daily percentage, face-to-face interview,

Secondary ID(s)

U1111-1194-7263

Source(s) of Monetary Support

Self funded

Secondary Sponsor(s)

Self funded

Results

• Date Completed: 29/11/2016