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

Completed

Conditions: Cancer patients admitted for Chemotherapy/Radiation therapy/Chemoradiation

Brief Summary: This study is a randomized, single blind, parallel group; trial for evaluating the effectiveness of oral care protocol for chemotherapy and radiation therapy induced oral complications among cancer patients. Experimental arm in this study will be receiving oral care protocol intervention and control arm participants will be receiving standard of care of oral care. The primary outcome measures will be occurrence of oral complications developed during the cancer treatment and from there after upto 1 year. The secondary outcomes will be duration of hospitalization and cost analysis related to occurrence of oral complications.

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
Occurrence of oral complications by using oral health assessment sheet	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
Functional activities of the mouth (swallowing, taste, pain, self oral care) by using a checklist	1 year
Duration of Hospitalization
Cost analysis:	Loss of productive days for patient/ relative, extra consultation costs due to complications, extra costs like food, transportation, length of stay.

Locations (1): KMC HOSPITAL
🇮🇳
Kannada, KARNATAKA, India
KMC HOSPITAL
🇮🇳Kannada, KARNATAKA, India
Radhika R Pai
Principal investigator
08242445858
radhika.r@manipal.edu