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Clinical trial for prevention of radiotherapy induced dry mouth in patients with oropharyngeal cancer

Prevention of Radiotherapy Induced Xerostomia by Intraductal Administration of N-Acetyl Cysteine in Patients with Oropharyngeal Malignancies: A Randomized Clinical Trial - NAC-RIX

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/026165
Enrollment
60
Registered
2020-06-26
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C109- Malignant neoplasm of oropharynx,unspecified

Interventions

Intervention1: N-acetyl cysteine (NAC): 3-5 ml of 2% NAC will be given as bilateral instillation in the duct of submandibular salivary gland before each radiotherapy fraction for 6-7 weeks Control Int

Sponsors

Dr Arvind Kumar Kairo
Lead Sponsor
Dr Ahitagni Biswas
Collaborator
Dr Alok Thakkar
Collaborator
Dr Pooja Gupta
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of oropharyngeal carcinoma 2. Either gender with age between 18-70 years (both inclusive) 3. Planned for radical external beam radiotherapy

Exclusion criteria

Exclusion criteria: 1. Patients with decreased mouth opening 2. A coexisting disease causing xerostomia 3. Revision cases 4. Denial for consent

Design outcomes

Primary

MeasureTime frame
Difference in severity grading of xerostomia according to RTOG EORTC scoring systemTimepoint: 2 weeks, 3 months, 6 months and 1 year—

Secondary

MeasureTime frame
Change in quality of lifeTimepoint: 2 weeks, 3 months, 6 months and 1 year;pH and viscosity of and IgA levels in salivaTimepoint: 2 weeks, 3 months, 6 months and 1 year;Quantity (in ml) of stimulated salivaTimepoint: 2 weeks, 3 months, 6 months and 1 year—

Countries

India

Contacts

Public ContactDr Arvind Kumar Kairo

All India Institute of Medical Sciences, Delhi

arvindkairo@yahoo.com9868491991

Outcome results

None listed

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