Circadian as A Prognostic Factor For Radiation Response in Cervical Cancer

Cervical Cancer Clinical Trial

Official title:

Influence of Radiation Patterns Following Circadian Rhythm Upon Response of Radiotherapy of Uterine Cervical Cancer : Melatonin as a Radiosensitivity and Biological Marker

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05511740
• Other study ID #: 27/PT02.FK/ETIK/2010
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: July 2014

Study information

• Verified date: August 2022
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cervical Cancer
• Radiotherapy Side Effect
• Uterine Cervical Neoplasms

Intervention

Radiation:
• Afternoon Radiation
Melatonin, a hormone of the pineal gland, which levels are characteristic of circadian patterns, regulated with low levels of excretion in the afternoon, rises gradually during the night, peaks at dawn, and falls back in the afternoon and late afternoon. Many studies prove the function and potential of melatonin as circadian biomarkers and well correlated with the development of cancer.The function of melatonin is as an antiproliferation substance or hormone, induces apoptosis, inhibits invasion and metastasis.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

References & Publications (3)

Jung B, Ahmad N. Melatonin in cancer management: progress and promise. Cancer Res. 2006 Oct 15;66(20):9789-93. Review. — View Citation

Karbownik M, Reiter RJ. Melatonin protects against oxidative stress caused by delta-aminolevulinic acid: implications for cancer reduction. Cancer Invest. 2002;20(2):276-86. Review. — View Citation

Vijayalaxmi, Thomas CR Jr, Reiter RJ, Herman TS. Melatonin: from basic research to cancer treatment clinics. J Clin Oncol. 2002 May 15;20(10):2575-601. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation response	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.	Four weeks after the completion of radiation