Cervical CancerNCT05511740
Circadian as A Prognostic Factor For Radiation Response in Cervical Cancer
A study testing Afternoon Radiation in people with Cervical Cancer and Radiotherapy Side Effect, run by Universitas Indonesia.
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. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Cervical Cancer, Radiotherapy Side Effect
- What is being tested?
- Afternoon Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%,
Who cannot join
- Distant metastasis and locally spread to the adjacent healthy tissue (urinary bladder or rectum).
About this study
Official title: Influence of Radiation Patterns Following Circadian Rhythm Upon Response of Radiotherapy of Uterine Cervical Cancer : Melatonin as a Radiosensitivity and Biological Marker
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.
- Conditions
- Cervical Cancer, Radiotherapy Side Effect
- Being tested
- Afternoon Radiation
- Keywords
- Radiosensitivity, Circadian rhythm
- Medical subject headings
- Uterine Cervical Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Morning Radiation | No intervention | Not described |
| Afternoon Radiation | Active comparator | Not described Receives: Radiation: Afternoon Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Four weeks after the completion of radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study startJan 2010
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irwan Ramli, Sp.Onk. Rad(K), Universitas Indonesia
- Investigators
- Irwan Ramli, MD, Principal investigator, Department of Radiation Oncology Cipto Mangunkusumo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511740
- Sponsor's protocol ID
- 27/PT02.FK/ETIK/2010
- Status last verified
- Aug 2022
- First submitted
- 11 Aug 2022
- Last updated
- 23 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 17047036Karbownik 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.
PubMed 11901547Vijayalaxmi, 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.
PubMed 12011138Ramli 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.
PubMed 36148886
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Radiation Patterns Following Circadian Rhythm Upon Response of Radiotherapy of Uterine Cervical Cancer : Melatonin as a Radiosensitivity and Biological Marker
- ClinicalTrials.gov ID
- NCT05511740
- Acronym / sponsor ID
- 27/PT02.FK/ETIK/2010
- Conditions
- Cervical Cancer, Radiotherapy Side Effect
- Keywords
- Radiosensitivity, Circadian rhythm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 23 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morning Radiation | No intervention | – |
| Afternoon Radiation | Active comparator | Radiation: Afternoon Radiation |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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%,
Key exclusion criteria (1 listed)
- Distant metastasis and locally spread to the adjacent healthy tissue (urinary bladder or rectum).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Afternoon RadiationMelatonin, 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. | Radiation | Afternoon Radiation |
Primary outcome
Radiation response
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Results publication: PubMed 17047036Jung 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 publication: PubMed 11901547Karbownik 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 publication: PubMed 12011138Vijayalaxmi, 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.
- Derived from this study: PubMed 36148886Ramli 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irwan Ramli, MD principal investigator
Department of Radiation Oncology Cipto Mangunkusumo Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Afternoon Radiation in people with Cervical Cancer and Radiotherapy Side Effect, run by Universitas Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation response (time frame: Four weeks after the completion of radiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05511740, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.