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Effects of neoadjuvant chemotherapy (NACT) on oral and dental health status in head and neck cancer patients.

A Prospective Observational Study on Oral Health Status in Head and Neck Cancer Patients undergoing Neo-Adjuvant Chemotherapy Regimen.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/07/020062
Enrollment
150
Registered
2019-07-08
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: C00-D49- Neoplasms

Interventions

None listed

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Head and Neck Cancer patients involving carcinoma of oral cavity, pharynx, larynx, para-nasal sinuses and salivary glands reporting in the Dental Department for Pre - NACT check up and providing consent. 2) Patients should be 18 or more than 18 years of age and diagnosed with malignancy in Head and Neck region. 3) Patients should be scheduled to undergo NACT by the Head and Neck DMG.

Exclusion criteria

Exclusion criteria: 1) Patients refusing to provide consent for the study. 2) Patients whose treatment is initiated prior to the observational study. 3) Patient unfit for providing consent and are in extreme discomfort or pain. 4) Patient has already undergone treatment for cancer previously and presently having recurrence.

Design outcomes

Primary

MeasureTime frame
The primary outcome is to assess the oral and dental health status in head and neck cancer patients before, during and after NACT regimen.Timepoint: Time point for dental and oral status assessment with respect to NACT cycle: a) First assessment before treatment starts(baseline) b) Secondassessmenteight days after first cycle c) Third assessment after the last cycle is completed

Secondary

MeasureTime frame
The secondary outcome is to compare the oral and dental health status in patients undergoing two different NACT regimens: Three drug combination (DCF) vs. two drug combination chemotherapy (DC) and to study the occurrence and intensity of pain of oral complications in the course of NACT regimen.Timepoint: Time point for dental and oral status assessment with respect to NACT cycle: a) First assessment before treatment starts(baseline) b) Second assessment eight days after first cycle c) Third assessment after the last cycle is completed

Countries

India

Contacts

Public ContactDr Madhura Sharma

Tata Memorial Hospital

sharmamadhura33@yahoo.in022024177000

Outcome results

None listed

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