A research study to know the effect of Resveratrol-Copper in reducing mouth ulcers in patients receiving chemoradiotherapy for locally advanced cancers of throat.

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/10/021508

Enrollment

102

Registered

2019-10-01

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: ResCu Arm: Standard Dosage and regimen will be as follows: Cisplatin 40 mg/m2 iv, once a week on Day 1 (IV over 1 to 3 hours) through the course of Radiotherapy. Adequate antiemetic mea

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically proven treatment naive 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: 1. Medical comorbidities like hypertensive, diabetes mellitus, Hepatitis B and HIV positive, etc. 2. Stage I/II oropharyngeal cancers indicated for single modality therapy 3. Patient unable to give informed consent. 4. Patient unsuitable for radical treatment.

Design outcomes

Primary

Measure	Time frame
To assess the incidence, severity and duration of oral mucositis during and after concurrent CTRT.Timepoint: Baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, 3 months after the treatment.	—

Secondary

Measure	Time frame
To assess changes and differences in Pain Score. To evaluate the use of NSAIDs. To assess patterns of weight loss. To document the use and duration of nasogastric tube feeding.Timepoint: Baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, 3 months after the treatment.;To assess tumour responseTimepoint: 1)Pretreatment 2) Day 21 3) End of treatment	—

Countries

India

Contacts

Public ContactDr Sarbani Ghosh Laskar

Tata Memorial Centre

sarbanilaskar@gmail.com02224177000

Outcome results

None listed

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