Role of polymorphisms in DNA repair genes in predicting severity of acute radiation reactions in carcinoma oropharynx.

Relationship of DNA repair gene polymorphisms with acute radiation reactions in squamous cell carcinoma of oropharynx

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

CTRI

Registry ID

CTRI/2017/07/009105

Enrollment

116

Registered

2017-07-26

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- Squamous cell carcinoma of oropharynx

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Biopsy proven cases of squamous cell carcinoma of oropharynx. Planned for radical radiotherapy (66Gy/33#) by 2-D conventional technique.

Exclusion criteria

Exclusion criteria: Cases planned for concurrent chemotherapy. Cases previously treated with radiotherapy. Patients with significant co-morbidities like diabetes mellitus or any form of immunosuppression. Cases with proven distant metastasis.

Design outcomes

Primary

Measure	Time frame
Development of CTCAE Grade 3 or 4 acute radiation reactions, namely, oral mucositis, dysphagia and dermatitis and correlation of DNA repair gene polymorphisms with the severity of these reactions.Timepoint: Onset of radiation reactions (less than or more than 10 days of start of radiotherapy). Duration of persistence of these reactions (less than or more than 6 weeks post completion of radiotherapy).	—

Measure

Time frame

Development of CTCAE Grade 3 or 4 acute radiation reactions, namely, oral mucositis, dysphagia and dermatitis and correlation of DNA repair gene polymorphisms with the severity of these reactions.Timepoint: Onset of radiation reactions (less than or more than 10 days of start of radiotherapy). Duration of persistence of these reactions (less than or more than 6 weeks post completion of radiotherapy).

—

Secondary

Measure	Time frame
Requirement of Ryles tube insertion. Documentation of weight loss incurred during treatment. Documentation of change in salivary gland function by salivary scintigraphy. Correlation of these outcomes with presence of DNA repair gene polymorphisms.Timepoint: Onset (less than or more than 10 days) Duration (less than or more than 6 weeks post radiotherapy)	—

Countries

India

Contacts

Public ContactAnkita Gupta

PGIMER

rtsushmita@gmail.com9592750011

Outcome results