Health Condition 1: C00-D49 Neoplasms
Conditions
Interventions
Intervention1: 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 o
Sponsors
Dr LP Bhaskar Bhuvan
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 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
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactDr L P Bhaskar bhuvan
HCGCC
Outcome results
None listed