Circadian as A Prognostic Factor For Radiation Response in Cervical Cancer

University of Indonesia (UI)

Status: Completed

Conditions: Radiotherapy Side Effect; Cervical Cancer

Treatments: Radiation: Afternoon Radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT05511740

27/PT02.FK/ETIK/2010

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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71 participants in 2 patient groups

Morning Radiation

No Intervention group

Afternoon Radiation

Active Comparator group

Treatment:

Radiation: Afternoon Radiation