NCT05511740

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 23, 2022

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

4.5 years

First QC Date

August 11, 2022

Last Update Submit

August 20, 2022

Conditions

Cervical CancerRadiotherapy Side Effect

Keywords

RadiosensitivityCircadian rhythm

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Morning Radiation

NO INTERVENTION

Afternoon Radiation

ACTIVE COMPARATOR
Radiation: Afternoon Radiation

Interventions

Afternoon RadiationRADIATION

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.

Afternoon Radiation

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%,

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 17047036RESULT

  • 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.

    PMID: 11901547RESULT

  • 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.

    PMID: 12011138RESULT

  • 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.

    PMID: 36148886DERIVED

MeSH Terms

Conditions

Uterine Cervical NeoplasmsRadiation Injuries

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesWounds and Injuries

Study Officials

  • Irwan Ramli, MD

    Department of Radiation Oncology Cipto Mangunkusumo Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant of Radiation Oncology

Study Record Dates

First Submitted

August 11, 2022

First Posted

August 23, 2022

Study Start

January 1, 2010

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

August 23, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
starting 6 months after publication
Access Criteria
requested via email