To study the effect of Resveratrol-Copper in reducing oral mucositis in patients receiving concurrent chemo-radiotherapy for locally advanced oropharyngeal cancers.
Phase 2
- Conditions
- Health Condition 1: C109- Malignant neoplasm of oropharynx,unspecified
- Registration Number
- CTRI/2019/06/019500
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Histologically proven oropharyngeal squamous cell carcinoma
2.Male or female patients 18 years and above.
3.Patients who have given written informed consent
4.Patients with performance status of 0,1 or 2 (ECOG scale)
5.Stage III/IV oropharyngeal cancers
6.Patients planned for radical chemoradiotherapy
Exclusion Criteria
a.Medical comorbidities like hypertensive, diabetes mellitus, Hepatitis B and HIV positive, etc.
b.Stage I/II oropharyngeal cancers indicated for single modality therapy
c.Patient unable to give informed consent.
d.Patient unsuitable for radical treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. reduction in oral mucositisTimepoint: 1. baseline <br/ ><br>2. week 1 <br/ ><br>3. week 2 <br/ ><br>4. week 3 <br/ ><br>5. week 4 <br/ ><br>6. week 5 <br/ ><br>7. week 6 <br/ ><br>8. week 7 <br/ ><br>9. 3 months post treatment
- Secondary Outcome Measures
Name Time Method 1. Tumor response <br/ ><br>2. Pain score <br/ ><br>3. Use of painkillers <br/ ><br>4. Need of nasogastric tube <br/ ><br>5. WeightTimepoint: 1. baseline <br/ ><br>2. week 1 <br/ ><br>3. week 2 <br/ ><br>4. week 3 <br/ ><br>5. week 4 <br/ ><br>6. week 5 <br/ ><br>7. week 6 <br/ ><br>8. week 7 <br/ ><br>9. 3 months