An experimental study comparing the effects of treatment response and severity of difficulty in swallowing in patients with pharynx or larynx cancer treated with two different radiation techniques (D0-IMRT versus standard IMRT).

A quasi-experimental study comparing dysphagia optimized intensity modulated radiotherapy (Do-IMRT) versus standard intensity modulated radiotherapy (S-IMRT).

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/08/036041

Enrollment

Registered

2021-08-31

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: C00-D49- Neoplasms

Interventions

Intervention1: Dysphagia optimized intensity modulated radiotherapy (Do-IMRT) technique: Contouring DARS (dysphagia and aspiration related structures) as a separate OAR (organ at risk) and reducing th

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients with stage T2-T4, N+, M0 carcinoma of oropharynx, hypopharynx or larynx with squamous cell carcinoma histology only 2) ECOG performance 0-2 3) Written informed consent.

Exclusion criteria

Exclusion criteria: • Patients with head and neck cancer with non-squamous cell carcinoma histology • Cancer sites other than oropharynx, hypopharynx, or supraglottic larynx • Patients with T1 N0 M0 (or M1) disease in the above-mentioned sites • Patients with recurrent cancer in the above-mentioned sites • Patients not fit for concurrent chemoradiation (or receiving chemotherapy other than weekly cisplatin) • Documented evidence of pre-existing swallowing dysfunction (not related to cancer) • Previous radiotherapy to the head and neck region • ECOG performance 3-4

Design outcomes

Primary

Measure	Time frame
Severity of dysphagiaTimepoint: 3 months post radiation	—

Secondary

Measure	Time frame
Treatment responseTimepoint: Comparison of pre-treatment PET-CT scan with post-treatment PET-CT scan	—

Countries

India

Contacts

Public ContactKarthik Subramaniam Thiagarajan

Sri Ramachandra University

dr_satishsrinivas@sriramachandra.edu.in9884780974

Outcome results

None listed

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