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

â??Development and evluation of an Oral care protocol on chemotherapy and radiation therapy induced oral complications in cancer patients: single blind, randomized clinical trialâ??

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/04/005709
Enrollment
140
Registered
2015-04-21
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: null- Cancer patients admitted for Chemotherapy/Radiation therapy/Chemoradiation

Interventions

Intervention1: Experimental arm: Oral Care Protocol: Description of the interventions: Patient in this arm receive oral care according to protocol which includes nursing assessment with

Sponsors

Radhika R Pai
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: Patient exclusion criteria Patients with cancers other than those affecting the oropharyngeal region

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Cost analysis: 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 Timepoint: During hospitalization. Counted from date of admission until discharge. ;Functional activities of the mouth (swallowing, taste, pain, self oral care) by using a checklistTimepoint: 1 year

Countries

India

Contacts

Public ContactDr Sourjya Banerjee

Manipal College of Dental Sciences Mangalore

ravikiran.ongole@manipal.edu9448430387

Outcome results

None listed

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