Oral cryotherapy for prevention of oral mucositis in patients receiving concurrent chemoradiotherapy in head and neck cancer
Not Applicable
- Conditions
- Health Condition 1: C13- Malignant neoplasm of hypopharynxHealth Condition 2: C10- Malignant neoplasm of oropharynxHealth Condition 3: C14- Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynxHealth Condition 4: C06- Malignant neoplasm of other and unspecified parts of mouth
- Registration Number
- CTRI/2020/02/023100
- Lead Sponsor
- Dr Mrs Manisha Pawar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Age > 18 years and <= 65years.
2. Stage III or IV squamous cell or undifferentiated carcinoma of the head and neck region originatingin the-oral cavity, oropharynx, hypopharynx, larynx and unknown primary with cervicallymphadenopathy.
3. No evidence of distant metastases.
4. Present at the time of data collection.
5. Patients who can follow instructions
Exclusion Criteria
1. Patient who are developmentally or physically unable to perform the intervention.
2. Patients who are not willing to participate.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess ease and tolerability of oral cryotherapy.Timepoint: For cisplatin administration, ease and tolerability of oral cryotherapy will be assessed weekly once or 3 weekly once. <br/ ><br> <br/ ><br>For radiotherapy, ease and tolerability of oral cryotherapy will be assessed daily for week 1, week 2, week 3 and week 4.
- Secondary Outcome Measures
Name Time Method 1) To find the incidence of oral mucositis among patients receiving concurrent chemo-radiotherapy after the administration of oral cryotherapy. <br/ ><br> <br/ ><br>2) To evaluate the effectiveness of oral cryotherapy on oral mucositis (the intensity, duration of mucositis, use of concomitant pain medications, pain scores).Timepoint: Incidence of oral mucositis will be assessed at the end of week 1, week 2, week 3 and week 4 of the treatment protocol. <br/ ><br> <br/ ><br>Effectiveness of oral cryotherapy will be assessed at the end of week 1, week 2, week 3 and week 4 of the treatment protocol.