Chemobrain in Head and Neck Cancers
- Conditions
- Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
- Registration Number
- CTRI/2022/09/045579
- Lead Sponsor
- il
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Histopathologically proven cases of HNSCC patients undergoing definitive chemoradiation with or without induction chemotherapy.
2.Age 18-70 years
3. Eastern Cooperative Oncology Group Performance status 0-2
4.Adequate organ function:
a)Adequate bone marrow function (e.g. platelets > 100 x 109/L, ANC > 1.5 x 109/L, etc)
b)Adequate liver function (e.g. ALT/AST < 1.5 x ULN, etc)
c)Adequate renal function (e.g. creatinine clearance > 50 ml/min)
d)Adequate cardiac function (e.g. LVEF >40%)
1.Known neuropsychological illness/ coexistent ?major depression/anxiety
2.Metastatic disease
3.Intake of antidepressant/ antipsychotic medications or receiving psychological therapy
4.Previously taking NSAIDS/ aspirin for any medical condition
5.Previous history of coronary artery disease and myocardial infarction.
6.Patients with recurrence/ second primary lesion.
7.Patients with oral primary, being treated with surgery for the primary disease.
8.Refusal to provide informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To determine the activity of celecoxib versus placebo in reducing cognitive decline in patients undergoing definitive CTRT in HNSCCTimepoint: 1. At Baseline (before start of therapy <br/ ><br>2. after completion of CTRT <br/ ><br>3. at 3 months <br/ ><br>4. 6 months after completion of CTRT <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method 2.To assess safety of celecoxib versus placebo with definitive chemoradiotherapy <br/ ><br>3.To determine factors predicting the cognitive decline <br/ ><br>4.To evaluate trend of activity and safety of celecoxib at follow up of 3 and 6 months <br/ ><br>Timepoint: 0 and 3 and 6 months