Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Cryotherapy with CTRT: Oral cryotherapy(ice cube or ice water or ice popsicles
5-7 times a day orally
Patient will have to keep the ice cubes during chemotherapy and before and after RT dose of the day)+ CTRT (As per NCCN guidelines)
Control Intervention1: Only CTRT: Standard CT-RT(As per NCCN guideli
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of Gr-3 to Gr-5 MucositisTimepoint: Baseline, weekly till end of CT-RT and 3 months post CT-RT | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Nandini Menon
Tata Memorial Hospital
Outcome results
None listed