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CTRI Number  CTRI/2020/02/023100 [Registered on: 03/02/2020] Trial Registered Prospectively
Last Modified On: 30/01/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Process of Care Changes 
Study Design  Single Arm Study 
Public Title of Study   Oral cryotherapy for prevention of oral mucositis in patients receiving concurrent chemoradiotherapy in head and neck cancer 
Scientific Title of Study   A Pilot study to assess the feasibility of oral cryotherapy for prevention of oral mucositis during administration of cisplatin with radiotherapy in patients with advanced carcinoma of head and neck at TMH. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mrs Manisha Pawar 
Designation  Professor and Vice-Principal 
Affiliation  Tata Memorial Hospital 
Address  Room No. 1, 13th Floor, Nursing Education Department, Homi Bhabha Building.

Mumbai
MAHARASHTRA
400012
India 
Phone  7738059723  
Fax    
Email  manisha.19pawar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mrs Manisha Pawar 
Designation  Professor and Vice-Principal 
Affiliation  Tata Memorial Hospital 
Address  Room no. 1, 13th Floor, Nursing Education Department, Homi Bhabha Building.

Mumbai
MAHARASHTRA
400012
India 
Phone  7738059723  
Fax    
Email  manisha.19pawar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ms Anusha Thomas 
Designation  MSc Nursing Second Year Student 
Affiliation  Tata Memorial Hospital 
Address  Room no. 1, Nursing Education Department, Homi Bhabha Building.

Mumbai
MAHARASHTRA
400012
India 
Phone  9769632286  
Fax    
Email  anusha_1605@yahoo.com  
 
Source of Monetary or Material Support  
Dr. (Mrs.) Manisha Pawar Tata Memorial Hospital, Dr. E Borges road, Parel. Mumbai-400012 
 
Primary Sponsor  
Name  Dr Mrs Manisha Pawar 
Address  Tata Memorial Hospital, Room No.1, 13th floor, Nursing Education Department, Homi Bhabha Buidling, Parel, Mumbai-400012 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mrs Manisha Pawar  Tata Memorial Hospital  Cobalt therapy department, Room number 4124, Basement, Main Building. General Day Care department , 5th floor, Main Building. Private Day Care department, 6th floor, Annex Building.
Mumbai
MAHARASHTRA 		 7738059723

manisha.19pawar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C06||Malignant neoplasm of other and unspecified parts of mouth, (2) ICD-10 Condition: C10||Malignant neoplasm of oropharynx, (3) ICD-10 Condition: C13||Malignant neoplasm of hypopharynx, (4) ICD-10 Condition: C14||Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not aplicable 
Intervention  Oral cryotherapy  Cryotherapy application The cryotherapy ice chips used will be prepared in a manner that will not cause irritation in the mouth of the patients and that could be easily moved to every corner of the mouth. It will be in semicircular shape and will measure about one inch in diameter and half inch width. Patients will be instructed to swish the ice chips around their oral cavities starting 5 mins before (treatment minus 5 mins) , during (treatment for 30 mins) and 5 mins after (treatment plus 5 mins) the administration of cisplatin. Patients will be instructed to swish the ice chips around their oral cavities starting before (treatment minus 5 mins) and 5 mins after (treatment plus 5 mins) radiation therapy. Once the ice melts, participants will be instructed to rinse the mouth with the liquid of melted ice to cool the large surface as possible of the oral mucosa and then they can swallow or spit out the water from the melted ice chips. Participants who will experience any pain or discomfort during the cryotherapy application will be advised to continue after a maximum of 60 secs break. Food or drinks, whenever possible, be consumed either before or after the session. If it will be intolerable for the participants to continue the application of ice chips then the intervention would be stopped.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  1. Patient who are developmentally or physically unable to perform the intervention.
2. Patients who are not willing to participate. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess ease and tolerability of oral cryotherapy.  For cisplatin administration, ease and tolerability of oral cryotherapy will be assessed weekly once or 3 weekly once.

For radiotherapy, ease and tolerability of oral cryotherapy will be assessed daily for week 1, week 2, week 3 and week 4. 
 
Secondary Outcome  
Outcome  TimePoints 
1) To find the incidence of oral mucositis among patients receiving concurrent chemo-radiotherapy after the administration of oral cryotherapy.

2) To evaluate the effectiveness of oral cryotherapy on oral mucositis (the intensity, duration of mucositis, use of concomitant pain medications, pain scores). 		 Incidence of oral mucositis will be assessed at the end of week 1, week 2, week 3 and week 4 of the treatment protocol.

Effectiveness of oral cryotherapy will be assessed at the end of week 1, week 2, week 3 and week 4 of the treatment protocol. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/02/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Oral mucositis (OM) is a common complication of cancer therapy. Mucositis from damage to the mucosal epithelium after delivery of chemotherapy or radiation designed to treat cancer. OM occurs in approximately 20% to 40% of patients receiving conventional chemotherapy, 80% of patients receiving high-dose chemotherapy, and nearly all patients receiving head and neck radiation therapy (H&N RT). Oral cryotherapy is the application of ice chips or ice-cold water to the mouth. Oral cryotherapy for chemotherapy-induced OM requires that patients suck on ice chips before, during, and after infusions of cytotoxic drugs. It is a low cost, natural treatment without serious side effects. Even in Tata memorial hospital, there are lack of studies reporting the use of oral cryotherapy for patients receiving cancer treatment. So with this pilot trial we would like to evaluate the tolerability and efficacy of oral cryotherapy in patients receiving head and neck cancer treatment where oral mucositis is a common toxicity encountered. If this study proved to be successful then it can be further used for a larger scale studies and in different malignacies with oral toxicity. Null Hypothesis- There will be no ease and tolerabilty for oral cryotherapy. 
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