Back to resultsCircadian as A Prognostic Factor For Radiation Response in Cervical Cancer
Primary Purpose
Cervical Cancer, Radiotherapy Side Effect
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Afternoon Radiation
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring Radiosensitivity, Circadian rhythm
Eligibility Criteria
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Morning Radiation
Afternoon Radiation
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05511740
Brief Title
Circadian as A Prognostic Factor For Radiation Response in Cervical Cancer
Official Title
Influence of Radiation Patterns Following Circadian Rhythm Upon Response of Radiotherapy of Uterine Cervical Cancer : Melatonin as a Radiosensitivity and Biological Marker
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 2010 (Actual)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Radiotherapy Side Effect
Keywords
Radiosensitivity, Circadian rhythm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Morning Radiation
Arm Type
No Intervention
Arm Title
Afternoon Radiation
Arm Type
Active Comparator
Intervention Type
Radiation
Intervention Name(s)
Afternoon Radiation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Radiation response
Description
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.
Time Frame
Four weeks after the completion of radiation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irwan Ramli, MD
Organizational Affiliation
Department of Radiation Oncology Cipto Mangunkusumo Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
starting 6 months after publication
IPD Sharing Access Criteria
requested via email
Citations:
PubMed Identifier
17047036
Citation
Jung B, Ahmad N. Melatonin in cancer management: progress and promise. Cancer Res. 2006 Oct 15;66(20):9789-93. doi: 10.1158/0008-5472.CAN-06-1776.
Results Reference
result
PubMed Identifier
11901547
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. doi: 10.1081/cnv-120001154.
Results Reference
result
PubMed Identifier
12011138
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. doi: 10.1200/JCO.2002.11.004.
Results Reference
result
PubMed Identifier
36148886
Citation
Ramli I, Susworo S, Nuranna L, Mansyur M, Harahap AR, Soetopo S, Siregar NC, Wanandi SI. Circadian as a prognostic factor for radiation responses in patients with cervical cancer: A nested case-control study. Oncol Rep. 2022 Nov;48(5):199. doi: 10.3892/or.2022.8414. Epub 2022 Sep 23.
Results Reference
derived
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Circadian as A Prognostic Factor For Radiation Response in Cervical Cancer
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