A Supportive Oral Radiation Protection (SORP) management protocol in patients with head and neck cancer undergoing radiotherapy

Clinical effectiveness of a Supportive Oral Radiation Protection (SORP) management protocol in patients with head and neck cancer undergoing radiotherapy: A randomized controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/082490

Enrollment

Registered

2025-03-17

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Health Condition 1: D- Radiation Therapy

Interventions

Intervention1: Supportive Oral Radiation Protection (SORP) management protocol: I Pre-Treatment Assessment: -Oral Health Evaluation: Conduct a thorough clinical and radiographic examination to identif

Eligibility

Inclusion criteria

Inclusion criteria: -Histopathological diagnosis of HNC -Primarily receiving definitive radiation with or without chemotherapy or surgery -Patients included in the study will be adults (= 18 years of age) -Patients willing to participate in the study

Exclusion criteria

Exclusion criteria: -Patients with cancers other than HNC -Patients with secondary or recurrent HNC, distant metastasis, skin cancer, congenital anomaly of the head and neck, and chronic illness. -Patient with mucositis grade 2 post radiation -Edentulous patients or having less than 10 teeth -Patient with restricted mouth opening -Patient with cognitive impairment, motor disability, non-ambulatory and mentally incapacitated or any previous or current psychiatric illness.

Design outcomes

Primary

Measure	Time frame
-To improve oral health status of cancer patients which will be evident clinically with reduced dental caries and gingival scores. -Early intervention and preventive measures can significantly reduce the risk of severe oral complications. -Patients can maintain better nutritional intake, experience less pain, and have a more positive treatment experience. -The oral complications are minimized; patients are more likely to complete their prescribed cancer treatment regimens.Timepoint: Baseline, 3 months, 6 months and 1 Year	—

Measure

Time frame

-To improve oral health status of cancer patients which will be evident clinically with reduced dental caries and gingival scores. -Early intervention and preventive measures can significantly reduce the risk of severe oral complications. -Patients can maintain better nutritional intake, experience less pain, and have a more positive treatment experience. -The oral complications are minimized; patients are more likely to complete their prescribed cancer treatment regimens.Timepoint: Baseline, 3 months, 6 months and 1 Year

—

Secondary

Measure	Time frame
-Enhanced Treatment Compliance: The oral complications are minimized; patients are more likely to complete their prescribed cancer treatment regimens. -The protocol developed in this study will assures uniform practice of oral care across the hospital. -If the oral protocol intervention is found to be effective, this approach could be incorporated into the clinical setting to promote evidence-based practice & to maximize patient outcomes.Timepoint: Baseline, 3 months, 6 months & 1 Year	—

Measure

Time frame

-Enhanced Treatment Compliance: The oral complications are minimized; patients are more likely to complete their prescribed cancer treatment regimens. -The protocol developed in this study will assures uniform practice of oral care across the hospital. -If the oral protocol intervention is found to be effective, this approach could be incorporated into the clinical setting to promote evidence-based practice & to maximize patient outcomes.Timepoint: Baseline, 3 months, 6 months & 1 Year

—

Countries

India

Contacts

Public ContactDr Atrey J Pai Khot

Goa Dental College and Hospital

amitakam66@gmail.com9823199347

Outcome results

None listed

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