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Dysphagia-optimized intensity-modulated radiotherapy versus standard intensity-modulated radiotherapy in head and neck cancer patients

Dysphagia-optimized intensity-modulated radiotherapy versus standard intensity-modulated radiotherapy in head and neck cancer patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
PACTR
Registry ID
PACTR202509621901433
Enrollment
40
Registered
2025-09-09
Start date
2022-12-01
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

Cancer

Interventions

dysphagia optimized intensity modified radiotherapy
standard intensity modulated radiotherapy

Sponsors

Tanta university Faculty of medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: • Age = 18 years. • Patient treated with radiotherapy for HNC (squamous cell carcinoma). • Disease of T1 to T4, N0 to N3, and non-metastatic disease. • CCRT is the planned treatment. • Radiation alone was also allowed. • Adequate cognitive ability to complete assessment questionnaires

Exclusion criteria

Exclusion criteria: • Records demonstrating a history of swallowing difficulties unrelated to HNC. • Prior radiation treatment to the head and neck area. • Involvement of retropharyngeal node, posterior pharyngeal wall or post cricoid. • Major surgery excluding biopsy or tonsillectomy. • History of tracheostomy insertion. • Any proven cancer occurred within the last 2 years

Design outcomes

Primary

MeasureTime frame
determine whether reducing the radiation dose to pharyngeal constrictors using Do-IMRT, would improve swallowing function compared to S-IMRT in HNC patients treated with radical chemo-radiation or radiation alone.

Secondary

MeasureTime frame
Investigate the longitudinal pattern of patient reported swallowing function post radiotherapy treatment using the MDADI; ? Investigate the impact of using Do-IMRT on (i) Normalcy of diet and public eating using the PSS HN scale; (ii) Swallowing performance using the 100 mL Water Swallow Test; (iii) Acute and late toxicity using NCI CTCAE v5.0. ? Assess patient-reported QoL and priority concerns using the UW-QoL questionnaire (v.04). Radiological assessment by CT or MRI was requested 6 weeks post radiotherapy, and RECIST was applied.

Countries

Egypt

Contacts

Public Contactnehal elmashad

Clinical oncology department Faculty of medicine Tanta university

nehalelmashad@gmail.com01094420401

Outcome results

None listed

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