Oral MucositisPhase 2/3NCT02868151
Effect of Oral Vitamin C in Assessing the Severity of Oral Mucositis in Chemoradiation of Head and Neck Cancers
A Phase 2/3 study testing Ascorbic Acid and Zinc acetate in people with Oral Mucositis, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- Ascorbic Acid and Zinc acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2016to Oct 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who are attending Mehdi Nawaz Jung cancer hospital for radiotherapy and who provide written consent for the study.
Who cannot join
- Patients with known allergy to vitamin C
- Patients with Glucose-6-phosphate dehydrogenase deficiency
- Patients with renal failure
Trial locations and contacts
1 site in 1 country.
India1 site
MNJ institute of oncology & regional cancer center
Hyderabad, Telangana, 500004
About this study
Official title: Effect of Ascorbic Acid Oral Supplementation in Assessing the Severity of Oral Mucositis in Chemo-radiation Therapy of Head and Neck Cancers.
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.
Read the 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
- Conditions
- Oral Mucositis
- Being tested
- Ascorbic Acid, Zinc acetate
- Keywords
- Oral mucositis, chemo radiotherapy, vitamin c,
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic AcidDrug
Also called Vitamin C
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.
Zinc acetateDrug
Zinc acetate 50mg tablets orally twice daily for entire period of cancer treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ascorbic Acid |
| GROUP C | Experimental | Zinc acetate tablets 50mg orally Receives: Drug: Zinc acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one and half years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2017
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Saveetha University, MNJ Institute of Oncology and Regional Cancer Center
- Responsible party
- Principal investigator, NALLAN CHAITANYA, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Investigators
- SANJEEVA KUMARI, MD, Principal investigator, MNJ Institute of Oncology and Regional Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868151
- Sponsor's protocol ID
- ECR/227/INSP/AP/2014
- Status last verified
- Mar 2019
- First submitted
- 6 Aug 2016
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: confidential data from hospital.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ascorbic Acid Oral Supplementation in Assessing the Severity of Oral Mucositis in Chemo-radiation Therapy of Head and Neck Cancers.
- ClinicalTrials.gov ID
- NCT02868151
- Acronym / sponsor ID
- ECR/227/INSP/AP/2014
- Conditions
- Oral Mucositis
- Keywords
- Oral mucositis, chemo radiotherapy, vitamin c,
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research CentreUniversity, hospital or other
- Collaborators
- Saveetha University, MNJ Institute of Oncology and Regional Cancer Center
- Study start
- Aug 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Ascorbic AcidAscorbic 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. |
| GROUP C | Experimental | Drug: Zinc acetateZinc acetate tablets 50mg orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who are attending Mehdi Nawaz Jung cancer hospital for radiotherapy and who provide written consent for the study.
Key exclusion criteria (3 listed)
- Patients with known allergy to vitamin C
- Patients with Glucose-6-phosphate dehydrogenase deficiency
- Patients with renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascorbic AcidAlso: Vitamin CAscorbic 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 | GROUP B |
| Zinc acetateZinc acetate 50mg tablets orally twice daily for entire period of cancer treatment | Drug | GROUP C |
Primary outcome
World Health Organization criteria of grading oral mucositis.for head and neck cancer patients
Time frame: one and half years.
oral mucositis severity would be measured weekly in all the patients during the entire treatment of radiotherapy/chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Individual participant dataSharing planned: No. confidential data from hospital.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SANJEEVA KUMARI, MD principal investigator
MNJ Institute of Oncology and Regional Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ascorbic Acid and Zinc acetate in people with Oral Mucositis, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
World Health Organization criteria of grading oral mucositis.for head and neck cancer patients (time frame: one and half years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.