Health Condition 1: K123- Oral mucositis (ulcerative)
Conditions
Interventions
None listed
Sponsors
AyurVAID Hospitals
Eligibility
Inclusion criteria
Inclusion criteria: 1.All oral cancer patients undergoing radiotherapy irrespective of type that are planned to be treated with primary or adjuvant Radiation Therapy using IMRT/3DCRT without chemotherapy. 2. Treatment plan is to receive a continuous course of IMRT/3DCRT delivered as single daily fractions with a cumulative radiation dose of 60-70 Gy. Planned radiation treatment fields must include at least two oral sites (left and right buccal mucosa, floor of mouth, left and right ventral/lateral tongue, soft palate) that are each planned to receive a total of = 60 Gy. 3. Age 18 years or older 4. Eastern Cooperative Oncology Group (ECOG) performance status = 2 5. Serum pregnancy test negative for females of childbearing potential 6. Properly obtained written informed consent
Exclusion criteria
Exclusion criteria: 1. Other Head and Neck Cancers, tumour of the larynx, hypopharynx, nasopharynx, sinuses, or salivary glands or past cancers with high risk of recurrence 2. Prior radiotherapy to the region of the Research cancer or adjacent anatomical sites or more than 25% of total body marrow-bearing area (potentially interfering with chemo tolerance) 3. Concurrent participation in another interventional clinical Research or use of another investigational agent within 30 days of the first dose of /Conventional care 4. Inability to eat soft solid food at baseline for reasons other than mouth soreness after surgery or dental procedures 5. Complete reliance on parenteral or gastrointestinal tube-delivered nutrition at baseline 6. Active infectious disease or ulcerative lesions or infections in the oral cavity at baseline 7. Presence of oral mucositis at baseline. (Subjects with mouth or throat pain solely due to post-operative effects are eligible.) 8. Known history of human immunodeficiency virus (HIV) or history of active hepatitis B/C (patients who have been vaccinated for hepatitis B and do not have a history of infection are eligible) 9. Female patients who are pregnant or breastfeeding 10. Known allergies or intolerance to Ay/Conventional Care compounds
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Weekly reduction of the percent incidence and severity of OM, defined as the proportion of subjects with any occurrence of WHO Grade 3 OM during the OM Assessment period 2.Compare the Safety of Ay (SK+PGH and Conventional Care administered topically as measured by: ? Frequency, duration, and severity of adverse events (AEs) and serious AEs (SAEs) during the AE Observation Period; Timepoint: weekly assessment for 9 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To compare the effectiveness of classical Ayurveda and Conventional Care prophylaxis during the weekly RI-OM Assessment period on the following parameters: 2.Reduction in incidence and total number of days of Grade 3 OM 3.Patient outcome change in the pain scores on the Vanderbilt Head and Neck Symptom Survey (VHNSS version 2) 4.Patient outcome change in Oral Pain scores (FACES Scale) 5.European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head & Neck module (EORTC-H&N) scoresTimepoint: Weekly assessment for 9 weeks | — |
Countries
India
Contacts
Public ContactDr Suprabha
AyurVAID Hospitals
Outcome results
None listed