Advanced Stage CancerPhase 2/3MIRCITNCT01706627
Melatonin In Reduction of Chemotherapy-Induced Toxicity (MIRCIT) Trial
A Phase 2/3 study testing 10 mg Melatonin and 20 mg Melatonin in people with Advanced Stage Cancer, run by Khon Kaen University at 2 sites in Thailand.
Trial summary
Meta-analysis of previous studies have shown that melatonin is a beneficial adjutant for reducing chemotherapy-induced toxicity; however no randomized, double-blind, placebo controlled trials have been conducted. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Stage Cancer
- What is being tested?
- 10 mg Melatonin and 20 mg Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 2 sitesThailand
- Study dates
- Aug 2007to Jun 2012
- Phase
- Phase 2/3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically proven advanced NSCLC, breast, head and neck, sarcoma cancer Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
- platelet count ≥100,000 cells/mm3
- white blood cell count ≥ 3,000 cell/mm3
- hemoglobin ≥ 10 g/dL
- serum creatinine ≤ 1.5 mg/dL
- bilirubin ≤ 2 mg/dL
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- AST ≤ 2.5 times upper limit of normal(ULN)for subjects without metastases or AST ≤ 2.5 times UNL for those with liver metastases
- New York Heart Association grade ≤ 2
- written consent
Who cannot join
- Patients who receive prior chemotherapy or biotherapy, radiotherapy or surgery within 1 month preceding randomization
- Patients who have more than one type of cancer or brain metastasis were excluded from the trial.
- Patients with moderate neuropathy (CTCAE grade ≥ 2)
- Patients with an active infection, or uncontrolled complications (i.e. blood glucose > 200 mg/dL, uncontrolled hypertension, unstable angina, history of congestive heart failure or history of myocardial infarction within one year).
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Khon Kaen Hospital
Khon Kaen, Changwat Khon Kaen, 40000
Srinagarind Hospital
Khon Kaen, Changwat Khon Kaen, 40002
About this study
Official title: Melatonin In Cancer Patients Receiving Chemotherapy: A Randomized, Double Blind, Placebo, Controlled Trial
Meta-analysis of previous studies have shown that melatonin is a beneficial adjutant for reducing chemotherapy-induced toxicity; however no randomized, double-blind, placebo controlled trials have been conducted. This study evaluates the effect of melatonin in improving quality of life and reducing chemotherapy-induced toxicity in advanced cancer patients. This is a multi-center, randomized, double-blind, placebo controlled trial conducted in patients with histologically proven advanced non small cell lung, breast, head and neck or sarcoma cancer. Mixed-block randomization, stratified by center and treatment scheme is used to divide eligible patients into three groups: melatonin 20 mg, 10 mg or matched placebo. The patients are required to take the studied drugs at night (after 21.00 pm) on the first day of chemotherapy and continue daily for six months. Standard treatment is chemotherapy according to each center's standard protocol. Study endpoints are QOL (FACT), adverse event frequency (CTCAE), oxidative stress status, melatonin level, and survival.
- Conditions
- Advanced Stage Cancer
- Being tested
- 10 mg Melatonin, 20 mg Melatonin, Matched placebo
- Keywords
- cancer, melatonin, adjuvant therapy, quality of life, survival, adverse events, oxidative stress
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 mg MelatoninDrug
Active Comparator: Drug: Melatonin 10 mg
20 mg MelatoninDrug
Active Comparator: Drug: Melatonin 20 mg
Matched placeboDrug
Matched placebo (identical formulation and delivery, without active ingredient)
| Study group | Role | What they receive |
|---|---|---|
| Matched placebo | Placebo comparator | Matched placebo (identical formulation and delivery, without active ingredient) Receives: Drug: Matched placebo |
| Drug: 10 mg Melatonin | Active comparator | 10 mg melatonin gelatin capsule Receives: Drug: 10 mg Melatonin |
| Drug: 20 mg Melatonin | Active comparator | 20 mg melatonin gelatin capsule Receives: Drug: 20 mg Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (FACT)
Self-reported questionnaires. FACT-L, FACT-B, FACT-H\&N and FACT-G Thai Version 4 has been previously validated. FACT-L, FACT-B, FACT-H\&N and FACT-G are used in lung, breast, head\&neck and sarcoma cancer patients, respectively. Change from baseline will be evaluated at 1,2,3 and 6 months after treatment.
Measured: Change from baseline in total scores at 6 months after treatment
Secondary outcomes (4)
Number of participants with adverse events
CTCAE Version 4.3
Measured: Baseline and 1,2,3 and 6 months after treatment
Oxidative stress status
8-isoprostane and 8-hydroxydeoxyguanosine urine and MDA plasma analysis
Measured: Chemotherapy cycles 1,2,3,4
Melatonin level
Blood, urine and saliva analysis
Measured: Chemotherapy cycle 1,2,3 and 4
Overall survival
Overall survival
Measured: Over 4 years of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startAug 2007
- Primary completionDec 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Stage CancerStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Collaborators
- Srinagarind Hospital, Khon Kaen University, Khon Kaen Hospital, General Drugs House Co.,LTD., Thailand Research Fund
- Responsible party
- Principal investigator, Nutjaree Pratheepawanit Johns, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706627
- Sponsor's protocol ID
- MIRCIT
- Other IDs
- TRF
- Acronym
- MIRCIT
- Status last verified
- Oct 2012
- First submitted
- 11 Oct 2012
- Last updated
- 15 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin In Cancer Patients Receiving Chemotherapy: A Randomized, Double Blind, Placebo, Controlled Trial
- ClinicalTrials.gov ID
- NCT01706627
- Acronym / sponsor ID
- MIRCIT / MIRCIT
- Conditions
- Advanced Stage Cancer
- Keywords
- cancer, melatonin, adjuvant therapy, quality of life, survival, adverse events, oxidative stress
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Collaborators
- Srinagarind Hospital, Khon Kaen University, Khon Kaen Hospital, General Drugs House Co.,LTD., Thailand Research Fund
- Study start
- Aug 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 15 Oct 2012 (estimated)
- 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.
Meta-analysis of previous studies have shown that melatonin is a beneficial adjutant for reducing chemotherapy-induced toxicity; however no randomized, double-blind, placebo controlled trials have been conducted. This study evaluates the effect of melatonin in improving quality of life and reducing chemotherapy-induced toxicity in advanced cancer patients. This is a multi-center, randomized, double-blind, placebo controlled trial conducted in patients with histologically proven advanced non small cell lung, breast, head and neck or sarcoma cancer. Mixed-block randomization, stratified by center and treatment scheme is used to divide eligible patients into three groups: melatonin 20 mg, 10 mg or matched placebo. The patients are required to take the studied drugs at night (after 21.00 pm) on the first day of chemotherapy and continue daily for six months. Standard treatment is chemotherapy according to each center's standard protocol. Study endpoints are QOL (FACT), adverse event frequency (CTCAE), oxidative stress status, melatonin level, and survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Matched placebo | Placebo comparator | Drug: Matched placeboMatched placebo (identical formulation and delivery, without active ingredient) |
| Drug: 10 mg Melatonin | Active comparator | Drug: 10 mg Melatonin10 mg melatonin gelatin capsule |
| Drug: 20 mg Melatonin | Active comparator | Drug: 20 mg Melatonin20 mg melatonin gelatin capsule |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- histologically proven advanced NSCLC, breast, head and neck, sarcoma cancer Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
- platelet count ≥100,000 cells/mm3
- white blood cell count ≥ 3,000 cell/mm3
- hemoglobin ≥ 10 g/dL
- serum creatinine ≤ 1.5 mg/dL
Key exclusion criteria (4 listed)
- Patients who receive prior chemotherapy or biotherapy, radiotherapy or surgery within 1 month preceding randomization
- Patients who have more than one type of cancer or brain metastasis were excluded from the trial.
- Patients with moderate neuropathy (CTCAE grade ≥ 2)
- Patients with an active infection, or uncontrolled complications (i.e. blood glucose > 200 mg/dL, uncontrolled hypertension, unstable angina, history of congestive heart failure or history of myocardial infarction within one year).
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 |
|---|---|---|
| 10 mg MelatoninActive Comparator: Drug: Melatonin 10 mg | Drug | Drug: 10 mg Melatonin |
| 20 mg MelatoninActive Comparator: Drug: Melatonin 20 mg | Drug | Drug: 20 mg Melatonin |
| Matched placeboMatched placebo (identical formulation and delivery, without active ingredient) | Drug | Matched placebo |
Primary outcome
Quality of Life (FACT)
Time frame: Change from baseline in total scores at 6 months after treatment
Self-reported questionnaires. FACT-L, FACT-B, FACT-H\&N and FACT-G Thai Version 4 has been previously validated. FACT-L, FACT-B, FACT-H\&N and FACT-G are used in lung, breast, head\&neck and sarcoma cancer patients, respectively. Change from baseline will be evaluated at 1,2,3 and 6 months after treatment.
4 secondary outcomes
Number of participants with adverse events
Time frame: Baseline and 1,2,3 and 6 months after treatment
Oxidative stress status
Time frame: Chemotherapy cycles 1,2,3,4
Melatonin level
Time frame: Chemotherapy cycle 1,2,3 and 4
Overall survival
Time frame: Over 4 years of the study
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 15 Oct 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 10 mg Melatonin and 20 mg Melatonin in people with Advanced Stage Cancer, run by Khon Kaen University at 2 sites in Thailand.
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 9 inclusion and 4 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 15 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quality of Life (FACT) (time frame: Change from baseline in total scores at 6 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2012.