Compare two oral medicines, celecoxib and glutamine, to prevent mouth sores from radiation in head and neck cancer patients - a double-blind research study.

Oral celecoxib versus oral glutamine as a prophylactic agent to prevent acute radiation mucositis in head and neck cancers- a double-blind randomized controlled trial - NIl

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/060223

Enrollment

110

Registered

2023-11-23

Start date

Unknown

Completion date

Unknown

Last updated

2023-12-19

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

Conditions

Health Condition 1: C01- Malignant neoplasm of base of tongue Health Condition 2: C04- Malignant neoplasm of floor of mouth Health Condition 3: C03- Malignant neoplasm of gum Health Condition 4: C13- Malignant neoplasm of hypopharynx Health Condition 5: C00- Malignant neoplasm of lip Health Condition 6: C10- Malignant neoplasm of oropharynx Health Condition 7: C14- Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx Health Condition 8: C08- Malignant neoplasm of

Interventions

Intervention1: Capsule CELECOXIB: Capsule CELECOXIB 200 mg once daily for 42 days Control Intervention1: Tablet L GLUTAMINE 10 gram dispersible tablets : L GLUTAMINE 20 gram dispersible tablets once d

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria- 1. Patients over the age of 18. 2. Patients with squamous cell carcinoma of the head and neck, receiving curative radiation with or without concurrent chemotherapy in the definitive or adjuvant setting

Exclusion criteria

Exclusion criteria: Exclusion Criteria- 1. Patients who have received celecoxib within one week of start of radiation 2.Patients receiving palliative radiation 3. Patients with prior history of radiation to the head and neck 4.History of GI bleeding/ulcers or inflammatory bowel disease 5. History of severe hepatic (Child-Pugh Class C)/renal impairment (CrCl 6.History of allergy to Celecoxib 7.History of thromboembolic events (myocardial infarction, stroke), cardiac arrhythmia (atrial fibrillation), or revascularization procedures (CABG). 8. History of pre-existing cardiovascular disease (Congestive heart failure)

Design outcomes

Primary

Measure	Time frame
To determine if the proportion of patients developing acute mucositis of RTOG grade 3 or above is less in the celecoxib arm compared to the glutamine armTimepoint: To determine if the proportion of patients developing acute mucositis of RTOG grade 3 or above is less in the celecoxib arm compared to the glutamine arm	—

Secondary

Measure	Time frame
To determine proportion of patients developing acute mucositis of RTOG grade 2 or above To determine time taken for developing acute RTOG grade 2,3, & 4 mucositis is less To determine NRS score of pain To determine proportion of patients requiring opioids is less To compare total dose of opioids in mg (morphine equivalent) in both arms To determine proportion of patients requiring tube feeding To compare the quality of life using EORTC QOL 30 & EOTC QOL 35 questionnaire version 3.0 To compare the side effect profile To compare the mean percentage, change in weight at the end of treatment To assess the locoregional recurrence at 6 monthsTimepoint: Patient will be reviewed every 5 fractions till completion of radiation Then the patient will be reviewed at 6 weeks post RT, 3 months post RT & 6 months post RT.	—

Measure

Time frame

To determine proportion of patients developing acute mucositis of RTOG grade 2 or above To determine time taken for developing acute RTOG grade 2,3, & 4 mucositis is less To determine NRS score of pain To determine proportion of patients requiring opioids is less To compare total dose of opioids in mg (morphine equivalent) in both arms To determine proportion of patients requiring tube feeding To compare the quality of life using EORTC QOL 30 & EOTC QOL 35 questionnaire version 3.0 To compare the side effect profile To compare the mean percentage, change in weight at the end of treatment To assess the locoregional recurrence at 6 monthsTimepoint: Patient will be reviewed every 5 fractions till completion of radiation Then the patient will be reviewed at 6 weeks post RT, 3 months post RT & 6 months post RT.

—

Countries

India

Contacts

Public ContactDr Salman Haider

Jawaharlal Institute of Postgraduate Medical Education and Research

shyamaprems1@gmail.com9787814215

Outcome results

None listed

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