A clinical trial to study the effectiveness of an oral care protocol in cancer patients receiving chemotherapy and radiation therapy.

Not Applicable

Completed

• Conditions: Health Condition 1: null- Cancer patients admitted for Chemotherapy/Radiation therapy/Chemoradiation

• Registration Number: CTRI/2015/04/005709
• Lead Sponsor: Radhika R Pai

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-11-30
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

Chemotherapy Patient Group

Patient inclusion criteria

Patients newly diagnosed to have cancer and receiving selected mucotoxic chemotherapy drugs.

Patients admitted in Medical Oncology wards and special wards.

Patients who are willing to participate in the study.

Radiation Therapy Patient Group

Patient inclusion criteria

Patients admitted in Radiation Oncology and special wards

Patients planned for the radiation to the head and neck area.

Patients who are in any stage of cancer receiving chemoradiation, only radiation or post-operative radiation.

Atleast 75% of both parotids are within the radiation field.

Patients who are willing to take part in the study.

Exclusion Criteria

Patient exclusion criteria

Patients with cancers other than those affecting the oropharyngeal region

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of oral complications by using oral health assessment sheetTimepoint: Patient assessment once a week during admission for Radiation/chemoratiation. Patient assessment once in every cycle of chemotherapy. Followup assessment once in two months after discharge upto 1 year following Radiation therapy/Chemoradiation/chemotherapy.

Secondary Outcome Measures

Name	Time	Method
Cost analysis: <br/ ><br>Loss of productive days for patient/ relative, extra consultation costs due to complications, extra costs like food, transportation, length of stay.Timepoint: During hospitalization;Duration of Hospitalization <br/ ><br>Timepoint: During hospitalization. <br/ ><br>Counted from date of admission until discharge. <br/ ><br>;Functional activities of the mouth (swallowing, taste, pain, self oral care) by using a checklistTimepoint: 1 year