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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

Not Applicable
Conditions
Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Registration Number
CTRI/2023/04/051712
Lead Sponsor
SVIMS
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Closed to Recruitment of Participants
Sex
Not specified
Target Recruitment
0
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Stimulated and unstimulated Salivary flowTimepoint: 3 months
Secondary Outcome Measures
NameTimeMethod
Visual Analog ScoreTimepoint: 3 months
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