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A clinical trial to study the effect of oral ice application in preventing oral ulcer associated with radiotherapy among cancer patients undergoing radiotherapy.

A randomised controlled trial to assess the effect of â??oral ice applicationâ?? in preventing mucositis associated with radiotherapy among cancer patients undergoing radiotherapy at regional cancer centre, PGIMER, Chandigarh 2012-13.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/08/003906
Enrollment
60
Registered
2013-08-21
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Oral mucositis among Head and Neck cancer patients who were undergoing for radical radiotherapy.

Interventions

Intervention1: Oral ice application, Routine management (Dispirine gargle, Mucaine gel): Experimental group: Oral ice application [ providing ice cubes (3.5cm Ã?2cmÃ?2cm) for subjects to hold in mout

Sponsors

Naseem M
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult males or females diagnosed with head and neck cancer and planned for radical radiotherapy and having normal mucosa

Exclusion criteria

Exclusion criteria: Patients diagnosed with head and neck cancer and planned for palliative radiotherapy. Patients who are coming for booster dose of radiation

Design outcomes

Primary

MeasureTime frame
Oral mucositis was assessed with the help of WHO oral toxicity scale and Low grade of mucositis was observed in interventional group as comparing with control group. Delay in the development of oral mucositis was also noted in the interventional group as compared to control groupTimepoint: Oral mucositis was assessed on 1st day of radiotherapy prior to treatment, On end of 1st week of treatment i.e. on 5th day of the treatment, On end of 2nd week of treatment i.e. on 10th day of the treatment, On end of 3rd week of treatment i.e. on 15th day of the treatment, On end of 4th week of treatment i.e. on 20th day of the treatment.

Secondary

MeasureTime frame
Effect of ice application on tumour size and responseTimepoint: Follow up visits by the patient. But this was not conducted due to limited time period

Countries

India

Contacts

Public ContactNaseem M

National Institute of Nursing Education (NINE) PGIMER, Chandigarh, India

sukhpal.trehan@yahoo.in09888536964

Outcome results

None listed

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