A study looking at benefit of oral non digestible starch in reducing rectal pain and diarrhea in patients undergoing radiation for treatment of cancer cervix - A pilot phase to assess feasibility
Phase 2
Completed
- Conditions
- Health Condition 1: null- Carcinoma cervix
- Registration Number
- CTRI/2010/091/000427
- Lead Sponsor
- Radiotherapy unit1 Christian Medical College Vellore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
Adult women aged between 18 and 70 yrs diagnosed to have carcinoma cervix planned for radical chemoirradiation and consented for recruitment.
Exclusion Criteria
Rectal infiltration of cancer
Diversion surgery of bowel
Preexisting gut disorders
Previous pelvic radiation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Grade 2, 3 and 4, functional and clinical proctitis graded in CTC V 3.o and RTOG toxicity criteria.Timepoint: at 1st 2nd 3rd 4th 5th 6th 7th and 8th week of radiation and 6 weeks following completion of radiation
- Secondary Outcome Measures
Name Time Method Incidence of Grade 2,3 and 4 enteritis and diarrhea graded in CTC V 3.o and RTOG toxicity criteria.Timepoint: at 1st 2nd 3rd 4th 5th 6th 7th and 8th week of radiation and 6 weeks following completion of radiation