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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

A phase II randomized trial on benefit of amylase resistant starch in reducing acute proctitis in patients undergoing pelvic radiation for carcinoma cervix - PILOT PHASE

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/000427
Enrollment
10
Registered
2010-06-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Carcinoma cervix

Interventions

Intervention1: Amylase resistant starch: 30gm administered daily orally mixed with milk, through out the course of radiotherapy (6-8 weeks) Control Intervention1: Digestible starch (corn flour): 30gm

Sponsors

Radiotherapy unit1 Christian Medical College Vellore
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: Rectal infiltration of cancer Diversion surgery of bowel Preexisting gut disorders Previous pelvic radiation

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

India

Contacts

Public ContactBalu Krishna S

Tamil Nadu Medical Council

drbalunair@gmail.com04162283145

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026