Sildenafil Oral Spray for Radiation-Induced Oral Mucositis

Phase II Randomized, Double-Blind, Placebo-Controlled Trial of Sildenafil Oral Spray for Radiation-Induced Oral Mucositis with Exploratory Analysis of PD-L1 and PDE5 Receptor Expression - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/101504

Enrollment

Registered

2026-01-19

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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: Sildenafil Oral Spray: The investigational product is an oral spray formulation of sildenafil, designed 82 for direct application to the oral mucosa. The spray is developed to provide r

Eligibility

Inclusion criteria

Inclusion criteria: Adults, ECOG 0-1, BIOPAY PROVEN HNSCC, Definitive RT or CCRT using IGRT, Standard OAR dose constraints, oral mucosa not included as OAR, Adequate baseline oral health and dental assessment completed and acute dental issues addressed prior to RT start (per institutional dental SOP) Consented to participate in the study

Exclusion criteria

Exclusion criteria: Adults more than 70, Palliative intent, Significant comorbidities, Altered fractational RT, Known hypersensitivity to sildenafil or formulation components, or those receiving systemic immunomodulatory therapies, Nitrates / unstable ischemic heart disease, Use of organic nitrates (sublingual, transdermal, oral or IV) within 48 hours prior to planned first dose, or planned use during the study

Design outcomes

Primary

Measure	Time frame
efficacy of sildenafil oral spray in reducing the severity of radiation-induced oral mucositisTimepoint: weekly during radiation, 3 monthly thereafter	—

Secondary

Measure	Time frame
Impact on Oral Intake and NutritionTimepoint: weekly during radiation, 3 monthly thereafter;Local control& DFSTimepoint: 6 and 12 months post-radiotherapy.;overall survivalTimepoint: at 2 years;Expression of PD-L1 and PDE5 ReceptorsTimepoint: baseline at the start and post completion of treatment	—

Countries

India

Contacts

Public ContactDr Rajesh Pasricha

AIIMS Bhopal

drrajesh_pasricha@yahoo.com917055701703

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026