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

NCT02868151 | Completed Phase 2 DMC

• 1 other identifier: ECR/227/INSP/AP/2014
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Oral mucositis, chemo radiotherapy, vitamin c,

Outcome Measures

Primary Outcomes (1)

• World Health Organization criteria of grading oral mucositis.for head and neck cancer patients

  oral mucositis severity would be measured weekly in all the patients during the entire treatment of radiotherapy/chemotherapy

  one and half years.

Study Arms (3)

GROUP A

NO INTERVENTION

Standard treatment followed in the regional cancer center for prevention and treatment of oral mucositis during chemo radiotherapy of cancers. 20% Benzocaine 15grms. twice daily for the entire treatment period

GROUP B

EXPERIMENTAL

Ascorbic acid oral supplementation 1g four times daily for the entire treatment period of 30 days and after treatment by tapering the dose of the drug to half for another month. The drug has to be started 2 days prior to initiation of treatment of cancer. Subdivided into 2 groups , 30 patients in each : sub group 1: only radiotherapy patients, subgroup 2 includes concurrent chemo-radiotherapy patients.

Drug: Ascorbic Acid

GROUP C

EXPERIMENTAL

Zinc acetate tablets 50mg orally

Drug: Zinc acetate

Interventions

Ascorbic Acid DRUG

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.

Also known as: Vitamin C

GROUP B

Zinc acetate DRUG

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

GROUP C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who are attending Mehdi Nawaz Jung cancer hospital for radiotherapy and who provide written consent for the study.

You may not qualify if:

• Patients with known allergy to vitamin C
• Patients with Glucose-6-phosphate dehydrogenase deficiency
• Patients with renal failure

Sponsors & Collaborators

• Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre: lead
• Saveetha University: collaborator
• MNJ Institute of Oncology and Regional Cancer Center: collaborator

Study Sites (1)

MNJ institute of oncology & regional cancer center

Hyderabad, Telangana, 500004, India

Location

MeSH Terms

Conditions

Stomatitis

Interventions

Ascorbic Acid; Zinc Acetate

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Acetic Acid; Acetates

Study Officials

• SANJEEVA KUMARI, MD

  MNJ Institute of Oncology and Regional Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, department of oral medicine and radiology, panineeya institute of dental sciences

Study Record Dates

• First Submitted: August 6, 2016
• First Posted: August 16, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: October 1, 2018
• Last Updated: March 20, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)