To check the effectiveness of oral metronomic therapy in improving the quality of life in advanced head and neck cancer patients.

Effectiveness of oral metronomic therapy vs supportive management in improving quality of life in metastatic and recurrent head and neck cancer: A randomized controlled trial. - NIL

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/085017

Enrollment

200

Registered

2025-04-16

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: Oral Metronomic Therapy drugs: Oral Metronomic Therapy drugs- methotrexate (10 mg/mÂ² weekly), celecoxib(200mg twice daily) and geftinib(250mg once daily) to be given and evaluated at b

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients(more than or equal to eighteen years) diagnosed with metastatic or recurrent head and neck cancers. 2. Patients with Eastern Cooperative Oncology Group performance scale of more than or equal to two. 3. Patients who can understand either English or Hindi.

Exclusion criteria

Exclusion criteria: 1. Patients below eighteen years of age. 2. Patients with significant co-morbid conditions that preclude safe participation in the study. 3. Pregnant or breastfeeding women, due to potential drug teratogenicity. 4. Patients with a known contraindication to the drugs used in OMT(e.g., allergy to methotrexate or celecoxib). 5. Patients with ECOG PS more than or equal to two. 6. Patients who do not understand either Hindi or English.

Design outcomes

Primary

Measure	Time frame
The primary objective of this study is to evaluate the effectiveness of oral metronomic therapy (OMT) in improving the quality of life (QoL) using the EORTC QLQ-C30 and QLQ-HN35 questionnaire in patients with metastatic and recurrent head and neck cancer.Timepoint: At baseline, 2 months, 4 months and 6 months.	—

Secondary

Measure	Time frame
Overall Survival (OS): To evaluate overall survival as a secondary outcome, determining if OMT extends survival times in comparison to supportive care.Timepoint: It will be evaluated at 6 months.;Progression-Free Survival (PFS): To compare the progression-free survival rates between patients receiving OMT and those receiving supportive management.Timepoint: This will be evaluated using radiological imaging and reporting at 3 months and 6 months.	—

Measure

Time frame

Overall Survival (OS): To evaluate overall survival as a secondary outcome, determining if OMT extends survival times in comparison to supportive care.Timepoint: It will be evaluated at 6 months.;Progression-Free Survival (PFS): To compare the progression-free survival rates between patients receiving OMT and those receiving supportive management.Timepoint: This will be evaluated using radiological imaging and reporting at 3 months and 6 months.

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Countries

India

Contacts

Public ContactDr Seema Mishra

All India Institute of Medical Sciences, New Delhi

seemamishra2003@gmail.com9899061105

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026