Circadian as A Prognostic Factor For Radiation Response in Cervical Cancer

Not Applicable

Completed

• Conditions: Radiotherapy Side Effect; Cervical Cancer
• Interventions: Radiation: Afternoon Radiation

• Registration Number: NCT05511740
• Lead Sponsor: Indonesia University

Brief Summary

The study was a Randomized Clinical Trial (RCT) or clinical trial comparing the results of radiation treatment of 2 treatment groups, i.e. subject groups irradiated in the morning and in the afternoon, to check melatonin levels in cervical cancer patients. Since it is known that the function of melatonin is as an antiproliferation substance or hormone, induces apoptosis, inhibits invasion and metastasis.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2022-08
• Study First Submitted: 2022-08-11
• Study First Submitted QC: 2022-08-20
• Last Update Submitted: 2022-08-20
• Study First Posted: 2022-08-23
• Last Update Posted: 2022-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• cervical cancer patients stage IIB-IIIB (FIGO)
• no previous treatment
• histopathologic examination results of squamous cell carcinoma (SCC)
• KPS > 70 with levels of Hb > 10 g%,

Exclusion Criteria

• Distant metastasis and locally spread to the adjacent healthy tissue (urinary bladder or rectum).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Afternoon Radiation	Afternoon Radiation	-

Primary Outcome Measures

Name	Time	Method
Radiation response	Four weeks after the completion of radiation	We assessed the change in tumor size between the initial examination and the fourth week after the completion of irradiation, to classify the tumor response based on the modified WHO criteria which categorized as good response or poor response.