A research study to find the effect of use of ice to prevent ulceration of mouth in patients receiving Chemotherapy and radiotherapy for head and Neck cancer
Not Applicable
- Conditions
- Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
- Registration Number
- CTRI/2020/07/026657
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Age 18 to 70-years
Histologically or cytologically confirmed head and neck squamous cell carcinoma planned for Adjuvant CT-RT or Radical CT-RT
ECOG PS 0-2
No underlying Mucositis at baseline
No contraindication to oral intake(presence of ryles tube, risk for aspiration pneumonia, OCF)
Willing to undergo study intervention(Oral-cryotherapy)
Exclusion Criteria
Decreased mouth opening causing difficulty in oral mucositis assessment
Patients receiving radical chemoradiation in unresectable oral cavity cancer or post neoadjuvant chemotherapy
Oral infections/Oral thrush at baseline
Active medical co-morbidities
Participating in any other trail that has oral mucositis as primary end point
Dental complications preventing intake of cold beverages
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of Gr-3 to Gr-5 MucositisTimepoint: Baseline, weekly till end of CT-RT and 3 months post CT-RT
- Secondary Outcome Measures
Name Time Method Compliance to definitive treatmentTimepoint: Weekly till end of definitive CT-RT;Cost incurredTimepoint: End of CT-RT;Quality of LifeTimepoint: Baseline and end of CT-RT