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A clinical trial to study the effect of drug pilocarpine in radiation induced dryness of mouth among patients with head and neck cancers

A prospective study to evaluate the efficacy of oral pilocarpine in radiation induced Xerostomia among patients with head and neck squamous cell carcinoma - PRIX

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/051712
Enrollment
126
Registered
2023-04-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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: TAB.PILOCARPINE: Pilocarpine 5 mg Thrice daily will be given during course of Radiotherapy and 3 months follow up period Control Intervention1: No placebo: No intervention in control gr

Sponsors

SVIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Histo pathologically proven squamous cell carcinoma of head & neck [oral cavity, oropharynx, nasopharynx, hypopharynx, larynx] Age : 18 -70 years Patients with ECOG performance status of 0-2 Stage I to IVb [AJCC : 8th edition] Patients receiving definitive or adjuvant RT (postoperative cases) with or without concurrent chemotherapy Patients who have given approved informed consent

Exclusion criteria

Exclusion criteria: Patients previously treated with radiotherapy to head & neck region Patients receiving palliative radiotherapy Cancers of salivary glands Patients with surgical removal of parotid / submandibular glands Patients with ECOG performance status of 3-4 [Appendix II] Patients allergic to pilocarpine Patients receiving tricyclic antidepressants, beta blockers & anti histaminics Patients suffering with closed angle glaucoma, asthma, COPD & coronary artery disease Pregnant & lactating women

Design outcomes

Primary

MeasureTime frame
Stimulated and unstimulated Salivary flowTimepoint: 3 months

Secondary

MeasureTime frame
Visual Analog ScoreTimepoint: 3 months

Countries

India

Contacts

Public ContactCherwin Venati

Sri Venkateswara Institute of Medical Sciences

drpranabandhu79@gmail.com9948367281

Outcome results

None listed

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