Chemobrain in Head and Neck Cancers

ROLE OF CELECOXIB IN REDUCING COGNITIVE IMPAIRMENT IN PATIENTS RECEIVING DEFINITIVE CHEMORADIATION FOR HEAD AND NECK CARCINOMA : A PHASE II RANDOMISED PLACEBO CONTROLLED TRIAL - CELCI-HN

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/09/045579

Enrollment

Registered

2022-09-16

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx

Interventions

Intervention1: Tablet Celecoxib: 100mg Per oral BD for 6 months post completion of Chemoradiation Control Intervention1: Tab Placebo(Same size and character as celecoxib): 100mg per oral BD for 6 mont

Eligibility

Inclusion criteria

Inclusion criteria: 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 c) Adequate renal function (e.g. creatinine clearance > 50 ml/min) d) Adequate cardiac function (e.g. LVEF >40%)

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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 2. after completion of CTRT 3. at 3 months 4. 6 months after completion of CTRT	—

Secondary

Measure	Time frame
2. To assess safety of celecoxib versus placebo with definitive chemoradiotherapy 3. To determine factors predicting the cognitive decline 4. To evaluate trend of activity and safety of celecoxib at follow up of 3 and 6 months Timepoint: 0 and 3 and 6 months	—

Countries

India

Contacts

Public ContactAparna Sharma

All India Institue of Medical Sciences

atul1@hotmail.com9818548149

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 6, 2026