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Effect of Oral Vitamin C in Assessing the Severity of Oral Mucositis in Chemoradiation of Head and Neck Cancers

NCT02868151 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2019-03-20

No results posted yet for this study

Summary

The surrounding controversies both advocating and simultaneously opposing the use of vitamin C, mostly extrapolating animal models to human models, it has not been used individually to assess the severity of oral mucositis during chemoradiotherapy.

The present study is undertaken to evaluate the effect of vitamin C oral supplements in assessing the severity of oral mucositis during chemoradiotherapy for oral cancer.

Conditions

  • Oral Mucositis

Interventions

DRUG

Ascorbic Acid

Ascorbic acid oral supplementation 1g four times daily for the entire treatment period and 30 days after treatment by tapering the dose of the drug to half. The drug has to be started 2 days prior to initiation of treatment of cancer.

DRUG

Zinc acetate

Zinc acetate 50mg tablets orally twice daily for entire period of cancer treatment

Sponsors & Collaborators

  • Saveetha University

    collaborator OTHER

  • MNJ Institute of Oncology and Regional Cancer Center

    collaborator OTHER_GOV

  • Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

    lead OTHER

Principal Investigators

  • SANJEEVA KUMARI, MD · MNJ Institute of Oncology and Regional Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-12-31
Completion
2018-10-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02868151 on ClinicalTrials.gov