FindTrial
Sign In

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

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/02/023100
Enrollment
30
Registered
2020-02-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C13- Malignant neoplasm of hypopharynx Health Condition 2: C10- Malignant neoplasm of oropharynx Health Condition 3: C14- Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx Health Condition 4: C06- Malignant neoplasm of other and unspecified parts of mouth

Interventions

Intervention1: 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 easil

Sponsors

Dr Mrs Manisha Pawar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age > 18 years and 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

Exclusion criteria: 1. Patient who are developmentally or physically unable to perform the intervention. 2. Patients who are not willing to participate.

Design outcomes

Primary

MeasureTime frame
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. For radiotherapy, ease and tolerability of oral cryotherapy will be assessed daily for week 1, week 2, week 3 and week 4.—

Secondary

MeasureTime frame
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).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. Effectiveness of oral cryotherapy will be assessed at the end of week 1, week 2, week 3 and week 4 of the treatment protocol.—

Countries

India

Contacts

Public ContactMs Anusha Thomas

Tata Memorial Hospital

manisha.19pawar@gmail.com7738059723

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026