Health Condition 1: null- Subjects with head and neck cancer scheduled to receive chemotherapy or radiotherapy as standard care and with history or prone to develop oral mucositis during cancer chemotherapy or radiotherapy
Conditions
Interventions
Intervention1: Turmeric Oral Rinse: subjects will be advised to use 10 ml of oral rinse for 1 minute 4 times daily for a period of 6 weeks starting from day 1 of standard anticancer care.
Control Inte
Sponsors
The Himalaya Drug Company
Eligibility
Inclusion criteria
Inclusion criteria: 1 Subjects with confirmed histopathologically with head and neck cancer (according to TNM classification) preferably oropharyngeal scheduled to receive chemotherapy or radiotherapy as a standard care. 2 Subjects with history or prone to develop oral mucositis during cancer chemotherapy or radiotherapy. 3 Subjects aged >18 years of either the sex. 4 Subjects willing to give a written informed consent and follow the schedule of the study as per the protocol.
Exclusion criteria
Exclusion criteria: 1 Has participated in a similar clinical investigation in the past four weeks. 2 Severe uncontrolled systemic disorders, diabetes, Hypertension, or genetic and endocrinal disorders. 3 Has used a similar product in the past four weeks. 4 Subjects who refused to sign informed consent. 5 Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mucositis Assessment: Condition of the patientâ??s mouth is assessed at weekly intervals, as per the World Health Organisation grading of mucositisTimepoint: At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5th week and end of 6th week | — |
Secondary
| Measure | Time frame |
|---|---|
| Burning sensationTimepoint: At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5th week and end of 6th week;Difficulty in chewingTimepoint: At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5th week and end of 6th week;Difficulty in drinkingTimepoint: At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5th week and end of 6th week;Difficulty in opening the mouthTimepoint: At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5th week and end of 6th week;Location of ulcersTimepoint: At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5th week and end of 6th week;Number of ulcersTimepoint: At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5th week and end of 6th week | — |
Countries
India
Contacts
Public ContactDr Padmanabha
M.S.Ramaiah Hospital
Outcome results
None listed