Oral cryotherapy for prevention of oral mucositis in patients receiving concurrent chemoradiotherapy in head and neck cancer

Not yet recruiting

• Conditions: 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,

• Registration Number: CTRI/2020/02/023100
• Lead Sponsor: Dr Mrs Manisha Pawar

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-01-30
• Study Start: 2020-03-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age > 18 years and ≤ 65years.
• 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.
• No evidence of distant metastases.
• Present at the time of data collection.
• Patients who can follow instructions.

Exclusion Criteria

• Patient who are developmentally or physically unable to perform the intervention.
• 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.	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 Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Tata Memorial Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Tata Memorial Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Dr Mrs Manisha Pawar

Principal investigator

7738059723

manisha.19pawar@gmail.com