Health Condition 1: K123- Oral mucositis (ulcerative) Health Condition 2: K137- Other and unspecified lesions of oral mucosa
Conditions
Interventions
Intervention1: Oro-T ORAL RINSE: Subjects will be advised to use (Rinse/swish the oral cavity) 10 ml of Oro-T ORAL RINSE for 1 minute 4 times daily (without any dilution).
Control Intervention1: Salt
Sponsors
The Himalaya Drug Company
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or non-pregnant / non-lactating female Subjects between >=18 to 2.Subjects with histologically or cytologically confirmed Head and Neck cancer. 3. Subjects scheduled to receive radiotherapy as a continuous course of IMRT (Intensity-modulated radiation therapy) with single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose between 60 Gy and 70 Gy With or without Chemotherapy: Subjects scheduled to receive a standard weekly regimen of Chemotherapy, which is prone to develop Oral Mucositis (e.g Regimens include Cisplatin / Cetuximab/ Paclitaxel/ Everolimus/ 5-FU). 4. Subjects with adequate visual access for examination of the oral cavity viz: lips, buccal mucosa, floor of mouth, ventral and lateral tongue and soft palate. 5. ECOG performance status 6. Subjects must have adequate marrow function. 7. Subject must consent to access, review and analysis of previous medical and cancer history, including imaging data by the sponsor or a third party nominated by the sponsor. 8. Ability to understand and sign a written informed consent document prior to any study-related procedures and ready to follow and in agreement to visits as per the study assessment visits. 9. Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraceptive measures (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study, and for 15 days following completion of study participation.
Exclusion criteria
Exclusion criteria: 1.Subjects with Metastatic disease 2. Subjects received chemotherapy or radiation treatment to the head and neck region within the previous 6 weeks 3. Presence of oral mucositis (WHO Score >= Grade 1) or other oral mucosal ulceration at study entry 4. Subjects requiring parenteral or gastrointestinal tube-delivered nutrition for any reason. 5. Subjects with presence of symptoms associated with Oral Mucositis like burning sensation, difficulty in chewing, difficulty in drinking and difficulty in mouth opening at the time of enrollment. 6. Known history/ case of HIV or active hepatitis B/C (patients who have been vaccinated for hepatitis B and do not have a history of infection are eligible) 7. Any significant, uncontrolled medical diseases or conditions, as assessed by the Investigators that would substantially increase the medical risks of participating in this study (i.e., uncontrolled diabetes, uncontrolled hypertension, NYHA II-IV congestive heart failure, myocardial infarction within 6 months of study, severe/ uncontrolled chronic pulmonary disease, uncontrolled clinically relevant pulmonary edema or active uncontrolled infection). 8. Subjects with inadequate hepatic and renal function. 9. Any other significant medical condition of oral cavity including untreated active oral or dental infection, including severe tooth decay (caries) 10. Evidence of immediate life-threatening disease or a life expectancy of less than 3 months as per Investigatorâ??s discretion 11. Subjects who have participated in any investigational drug clinical study within one month of screening. 12. Refractory/ terminally ill patients. 13. Any systemic disorder (including Sjogren syndrome) which have direct impact on the normal condition of oral cavity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the comparative efficacy of Oro-T ORAL RINSE as compared to the Salt with or without Baking Soda water for Oral Mucositis during Cancer Radiotherapy with or without Chemotherapy in terms of: 1.Percentage of subjects developing Oral Mucositis (WHO grade). 2.Delay in the onset of Oral Mucositis.Timepoint: Visit 1- Screening (within 7 days prior to Day 1) Visit 2- Baseline, Day 1 Visit 3- At the end of 1st week/ Day 7 (±1day) Visit 4- At the end of 2nd week/ Day 14 (±1day) Visit 5- At the end of 3rd week/ Day 21 (±1day) Visit 6- At the end of 4thweek/ Day 28 (±1day) Visit 7- At the end of 5th week/ Day 35 (±1day) Visit 8- At the end of 6thweek/ Day 42/completion of Radiotherapy/ Chemotherapy(±1day) Visit 9- EOS: At 3 weeks post completion of Chemotherapy/ Radiotherapy (±1day) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Incidence of intolerable mucositis 2.Incidence of delay in initiation of scheduled treatments (Radiotherapy/ Chemotherapy) due to Oral Mucositis. 3 Comparative assessment in Quality of Life PROMs (Patient Reported Outcome Measures) questionnaire. 4.Incidence of hospitalization due to Oral Mucositis. 5.Incidence of AE (Oral local adverse event)Timepoint: Visit 1- Screening (within 7 days prior to Day 1) Visit 2- Baseline, Day 1 Visit 3- At the end of 1st week/ Day 7 (±1day) Visit 4- At the end of 2nd week/ Day 14 (±1day) Visit 5- At the end of 3rd week/ Day 21 (±1day) Visit 6- At the end of 4thweek/ Day 28 (±1day) Visit 7- At the end of 5th week/ Day 35 (±1day) Visit 8- At the end of 6thweek/ Day 42/completion of Radiotherapy/ Chemotherapy(±1day) Visit 9- EOS: At 3 weeks post completion of Chemotherapy/ Radiotherapy (±1day) | — |
Countries
India
Contacts
Public ContactDr Soorya Narayan H
The Himalaya Drug Company
Outcome results
None listed