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

Phase 2

Completed

• Conditions: Radiation- induced diarrhoea; Probiotics, Lactobacillus acidophilus, Bifidobacterium animalis subsp. Lactis, induced diarrhoea, cervical cancer

• Registration Number: TCTR20170314001
• Lead Sponsor: Self funded

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-11-29
• Study Start: 2017-03-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 57

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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,