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

Primary Purpose

Oral Mucositis

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Ascorbic Acid
Zinc acetate
Sponsored by
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oral Mucositis focused on measuring Oral mucositis, chemo radiotherapy, vitamin c,

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • MNJ institute of oncology & regional cancer center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

GROUP A

GROUP B

GROUP C

Arm Description

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

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.

Zinc acetate tablets 50mg orally

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 6, 2016
Last Updated
March 18, 2019
Sponsor
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Collaborators
Saveetha University, MNJ Institute of Oncology & Regional cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02868151
Brief Title
Effect of Oral Vitamin C in Assessing the Severity of Oral Mucositis in Chemoradiation of Head and Neck Cancers
Official Title
Effect of Ascorbic Acid Oral Supplementation in Assessing the Severity of Oral Mucositis in Chemo-radiation Therapy of Head and Neck Cancers.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Collaborators
Saveetha University, MNJ Institute of Oncology & Regional cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Oral mucositis is a predictable and unavoidable representation during the course of radiotherapy employed for treatment of head and neck cancers. The term oral mucositis is used to describe inflammation of the oral mucosa, a separate entity distinct from oral lesions with other pathogenic background generally summarized as stomatitis. The cells that line the gastrointestinal tract from the mouth to the rectum are especially vulnerable to such changes. The incidence and severity of oral mucositis is influenced by the type of antineoplastic treatment administered and patient related factors. The pathogenesis of radiation mucositis though not completely understood, is usually either by direct DNA damage or via an indirect mechanism of releasing free radicals upon radiolysis of water effecting the oral epithelium.It is associated with significant morbidity, pain, odynophagia, malnutrition thereby affecting the overall quality of life in these patients and carrying a more important risk of systemic infections particularly in impaired host defense setup.In addition to acute damage wide range of GI mucosal involvement occurs during radiotherapy. Various radiation modifying agents have been used which can either selectively protect normal cells but not tumor cells against therapeutic damage or can selectively enhance the effect of radiation on tumor cells but not on normal cells thereby improving efficacy of radiation therapy. In spite of extensive research most of them are found to be toxic. Antioxidants represent most selective radiation modifying agents that are non toxic to humans. However, because of many conflicting hypothesis on their usage affecting tumor response and also decreasing the radiation induced toxicity on normal cells, recommendations have followed for their non usage during chemo-radiotherapy. In spite of such reservations on behalf of oncologists over 70% of patients are on antioxidant supplements such as those containing vitamin A, vitamin C and polar carotenoids with or without the knowledge of oncologists. Antioxidants can neutralize those free radicals generated during radio-chemo therapy enhancing body's antioxidant stores in order to prevent mucositis and to maintain healthy oral tissues. Literature survey provides exhaustive list of such antioxidants successfully implicated in controlling oral mucositis to some extent. Antioxidants such as beta carotene, vitamin E and vitamin C in combination, glutamine, glutathione have been studied. Vitamin C is a water soluble nutrient that has wide antioxidant and wound healing properties. It has been widely in scurvy patients but its effect on conventional cancer therapy by radiation and chemotherapy were little known. Limited preclinical data suggested that this vitamin at high concentrations increased the toxicity of certain chemotherapeutic drugs in animals. Recommended daily allowance (RDA) for vitamin C is 90mgper day for men and 75mg per day for women, upper limit being 2000mg per day. Evidence points out that the intake to achieve therapeutic tissue concentration in normal people should be several times higher than RDA. Conversely a recent study implicated dangers of consuming high doses of vitamin C which may turn from antioxidant to pro oxidant interfering radiotherapy. However it should be noted that the conditions used in the above study prevailed were invitro in nature, which cannot reflect an identical situation invivo. Few other studies believed that it can enhance immune function by increasing natural killer cells and lymphocyte activity. With such controversial background and paucity of data in human intervention, this study is undertaken to evaluate the effect of vitamin c in assessing the severity of oral mucositis in patients undergoing cancer chemo and radiotherapy concurrently

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis
Keywords
Oral mucositis, chemo radiotherapy, vitamin c,

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GROUP A
Arm Type
No Intervention
Arm Description
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
Arm Title
GROUP B
Arm Type
Experimental
Arm Description
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.
Arm Title
GROUP C
Arm Type
Experimental
Arm Description
Zinc acetate tablets 50mg orally
Intervention Type
Drug
Intervention Name(s)
Ascorbic Acid
Other Intervention Name(s)
Vitamin C
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Zinc acetate
Intervention Description
Zinc acetate 50mg tablets orally twice daily for entire period of cancer treatment
Primary Outcome Measure Information:
Title
World Health Organization criteria of grading oral mucositis.for head and neck cancer patients
Description
oral mucositis severity would be measured weekly in all the patients during the entire treatment of radiotherapy/chemotherapy
Time Frame
one and half years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients who are attending Mehdi Nawaz Jung cancer hospital for radiotherapy and who provide written consent for the study. Exclusion Criteria: Patients with known allergy to vitamin C Patients with Glucose-6-phosphate dehydrogenase deficiency Patients with renal failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SANJEEVA KUMARI, MD
Organizational Affiliation
MNJ Institute of Oncology & Regional cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MNJ institute of oncology & regional cancer center
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500004
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
confidential data from hospital.

Learn more about this trial

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

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