To study the effect of Resveratrol-Copper in reducing oral mucositis in patients receiving concurrent chemo-radiotherapy for locally advanced oropharyngeal cancers.

A double arm, phase two randomised control study to assess the effect of Resveratrol-Copper in reducing oral mucositis in patients receiving concurrent chemo-radiotherapy for locally advanced oropharyngeal cancers.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/06/019500

Enrollment

102

Registered

2019-06-03

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C109- Malignant neoplasm of oropharynx,unspecified

Interventions

Intervention1: Resveratrol-Copper: 5.6 mg Resveratrol Copper 560 ng of copper Dose-thrice a day Duration of 39 days(35 -40 days) Control Intervention1: NOT APPLICABLE: NOT APPLICABLE

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
1. reduction in oral mucositisTimepoint: 1. baseline 2. week 1 3. week 2 4. week 3 5. week 4 6. week 5 7. week 6 8. week 7 9. 3 months post treatment	—

Secondary

Measure	Time frame
1. Tumor response 2. Pain score 3. Use of painkillers 4. Need of nasogastric tube 5. WeightTimepoint: 1. baseline 2. week 1 3. week 2 4. week 3 5. week 4 6. week 5 7. week 6 8. week 7 9. 3 months	—

Countries

India

Contacts

Public ContactDr Sarbani Ghosh Lashkar

TATA MEMORIAL HOSPITAL,MUMBAI

sarbanilaskar@gmail.com02224177000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026