| CTRI Number |
CTRI/2026/02/102654 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
31/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Other |
|
Public Title of Study
|
A clinical Trial Evaluating the Efficacy of Oral Glutathione and Vitamin C in Preventing Chemotherapy-Induced Oral Mucositis in Cancer Patients |
|
Scientific Title of Study
|
A Randomized double blinded placebo-controlled Trial Evaluating the Efficacy of Oral Glutathione and Vitamin C in Preventing Chemotherapy-Induced Oral Mucositis in Cancer Patients (GLOMUC Trial) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr L P Bhaskar bhuvan |
| Designation |
Medical Oncologist |
| Affiliation |
HCGCC |
| Address |
HCG Cancer Centre, Plot no 10, Survey no 13P, APIIC Health City, Arilova, Chinnagadili, Visakhapatnam 530040
Visakhapatnam
ANDHRA PRADESH
530040
India |
| Phone |
9154144100 |
| Fax |
|
| Email |
bhaskarlp60@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr L P Bhaskar bhuvan |
| Designation |
Medical Oncologist |
| Affiliation |
HCGCC |
| Address |
HCG Cancer Centre, Plot no 10, Survey no 13P, APIIC Health City, Arilova, Chinnagadili, Visakhapatnam 530040
Visakhapatnam
ANDHRA PRADESH
530040
India |
| Phone |
9154144100 |
| Fax |
|
| Email |
bhaskarlp60@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr L P Bhaskar bhuvan |
| Designation |
Medical Oncologist |
| Affiliation |
HCGCC |
| Address |
HCG Cancer Centre, Plot no 10, Survey no 13P, APIIC Health City, Arilova, Chinnagadili, Visakhapatnam 530040
Visakhapatnam
ANDHRA PRADESH
530040
India |
| Phone |
9154144100 |
| Fax |
|
| Email |
bhaskarlp60@gmail.com |
|
|
Source of Monetary or Material Support
|
| HCG Cancer Centre, Plot no 10, Survey no 13P, APIIC Health City, Arilova, Chinnagadili, Visakhapatnam 530040, Andhra Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr LP Bhaskar Bhuvan |
| Address |
HCG Cancer Centre, Plot no 10, Survey no 13P, APIIC Health City, Arilova, Chinnagadili, Visakhapatnam |
| Type of Sponsor |
Other [NA] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr L P Bhaskar bhuvan |
HCG Cancer Centre |
OPD no 09, HCG Cancer Center, Plot no 10, Survey no 13P, APIIC Health city,Arilova, Chinnagadili
Visakhapatnam
ANDHRA PRADESH |
09154144100
bhaskarlp60@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee HCG Cancer Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral Glutathione with Vitamin C |
L Glutathione of 240 mg to 250mg and vitamin C 40-60mg per tablet BD from day 6 to day 10 of chemotherapy
Study period of the patient: From the day 6 of chemotherapy to the day 14 of chemotherapy |
| Comparator Agent |
Placebo |
placebo drug BD from day 6 to day 10 of chemotherapy along with lignocaine jelly three times a day with or without tramadol as per physicians’ recommendation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 18-60 years.2.Patients should receive intravenous cancer chemotherapy neoadjuvant, adjuvant, and palliative intent.3. Chemotherapy should be anthracycline, infusional 5 FU.4. Patients should have CTCAE v 6 grade 2 and above OM on day 5.5. Should have adequate renal and liver functions.6. Patients should have an adequate bone marrow function with Haemoglobin (greater than) 8g/dl, Total Leukocyte count (greater than) 4000/mm3, platelet count of (greater than)1.5 lac/mm3 prior to chemotherapy.7. Patient should be verbally communicating and willing to give the response.8. Patient performance status to be ECOG 0 or 1.9. Patients should be able to take orally.10. Patient has a predicted life expectancy of (greater or equal to)6 months. |
|
| ExclusionCriteria |
| Details |
1.Patients who are not compliance with tablet medication.2. Patient who are dependent on Feeding jejunostomy, or Total Parenteral Nutrition and not able to take orally.3. Patients who are either HBSAg, HCV, or HIV positive patients.4. Patients who are on oral metronomic chemotherapy or targeted therapy.5. Patients who are on concurrent radiation treatment.6. Patient is pregnant or breast feeding. (Females of childbearing potential are require having a negative urine pregnancy test prior to entering the study.).7. Patient having poor social support.8. SGOT (AST) (greater than) 2.0 x upper limit of normal (ULN) and SGPT (ALT) (greater than)2.0 x ULN and Bilirubin (greater than)1.5 x ULN and Serum creatinine (greater than) UL.9. Patients with history active tuberculosis or active fungal infections or oral thrush, dental infections, allergic bronchial asthma.10. Patients with history of leucoplakia, erythroplakia, oral cavity cancers, non-healing ulcers in the oral cavity.11. Patients with history of coronary artery disease with left ventricle ejection fraction less than 55% or cardiac conduction abnormalities.12. Active smoking and alcohol intake (should be stopped with in last 3 months).13. Patients with acute or chronic liver disease and kidney disease. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Patients’ oral cavity will be examined on day 10 and day 14 of chemotherapy.
2. Weight and serum albumin will be checked at base line and on day 14 of chemotherapy.
3. CTCAE v 6 grade of OM on day 5, day 10 and day 14 of chemotherapy
4. Duration of CTCAE v 6 grade 2 and above OM, is calculated.
5. VAS Pain score in OM is assessed in both the groups day 5, day 10, day 14 of chemotherapy.
6. QOL of OM is assessed in both the groups on day 14 of chemotherapy based on OHIP 14 Scale. |
1. Patients’ oral cavity will be examined on day 10 and day 14 of chemotherapy.
2. Weight and serum albumin will be checked at base line and on day 14 of chemotherapy.
3. CTCAE v 6 grade of OM on day 5, day 10 and day 14 of chemotherapy
4. Duration of CTCAE v 6 grade 2 and above OM, is calculated.
5. VAS Pain score in OM is assessed in both the groups day 5, day 10, day 14 of chemotherapy.
6. QOL of OM is assessed in both the groups on day 14 of chemotherapy based on OHIP 14 Scale. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Oral mucositis (OM) is a common, debilitating complication in cancer patients receiving chemotherapy, especially with 5-fluorouracil (5-FU) or anthracycline-based regimens. OM manifests as painful ulcerations, increasing infection risk, causing nutritional compromise, and interrupting cancer treatment. Standard preventive measures exist, but are not effective for all regimens. Evidence suggests that oxidative stress contributes to OM pathogenesis, and antioxidants like glutathione, supported by vitamin C, may reduce its severity. Real world experience from our institute indicate that glutathione combined with vitamin C (GC) supplementation can lower OM grade/severity. |