Stage II and III Breast CancerPhase 2/3MIQOL-BNCT01557478
Melatonin as Adjuvant Therapy in Breast Cancer Patients
A Phase 2/3 study testing Melatonin in people with Stage II and III Breast Cancer, run by Khon Kaen University at 2 sites in Thailand.
Trial summary
The study evaluate the effect of melatonin in improving quality of life and reducing post operative pain and chemotherapy-induced toxicity in breast cancer patients. This is a multi-center, randomized, double-blind, placebo controlled trial conducted in stage II or III breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Stage II and III Breast Cancer
- What is being tested?
- Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 2 sitesThailand
- Study dates
- Mar 2012to Sep 2016
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically proven stage II or III breast 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
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- bilirubin ≤ 2 mg/dL
- AST ≤ 2.5 times upper limit of normal (ULN)
- New York Heart Association grade ≤ 2
- written consent
Who cannot join
- received prior chemotherapy or biotherapy, radiotherapy or surgery within 1 month preceding randomization,
- had more than one type of cancer or brain metastasis
- moderate neuropathy (CTCAE grade ≥ 2)
- active infection
- 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
Srinagarind Hospital
Khon Kaen, Changwat Khon Kaen, 40002
Maharat Nakorn Ratchasima Hospital
Nakorn Ratchasima, Nakorn Ratchasima
About this study
Official title: Melatonin in Improving the Quality of Life of Breast Cancer Patients and Reduction of Postoperative Pain and Chemotherapy Induced Toxicity
The study evaluate the effect of melatonin in improving quality of life and reducing post operative pain and chemotherapy-induced toxicity in breast cancer patients. This is a multi-center, randomized, double-blind, placebo controlled trial conducted in stage II or III breast cancer patients. Mixed-block randomization, stratified by center and treatment scheme is used to divide eligible patients into two groups: melatonin 20 mg or matched placebo. The patients are required to take the studied drugs at night (after 21.00 pm) on the first night prior to surgery and continue for 24 months. Standard treatment is surgery followed by chemotherapy according to each center's standard protocol. Study endpoints are QOL (FACT-B), pain (VAS 0-10), adverse event frequency, sleep quality (VAS 0-10), recurrence rate and progression-free survival.
- Conditions
- Stage II and III Breast Cancer
- Being tested
- Melatonin, match placebo
- Keywords
- breast cancer, melatonin, adjuvant therapy, quality of life, pain, sleep, survival, adverse events
- Medical subject headings
- Breast Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
20 mg melatonin gelatin capsule (1) taken orally after 21:00 hours each night throughout the study
match placeboDrug
placebo gelatin capsule (1) taken orally after 21:00 hours each night throughout the study
| Study group | Role | What they receive |
|---|---|---|
| Matched placebo | Placebo comparator | Matched placebo (identical formulation and delivery, without active ingredient) Receives: Drug: match placebo |
| Melatonin 20mg | Active comparator | 20 mg melatonin gelatin capsule Receives: Drug: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (FACT-B Version 4)
Self-reported questionnaire. FACT-B Thai Version 4 has been previously validated. Change from baseline will be evaluated at months 2,4,6,12,18,24.
Measured: Change from baseline in TOI scores at 6 months
Secondary outcomes (5)
Pain and amount of pain medication used
Self-reported VAS scale (0-10)
Measured: Before and up to 72 hours after surgery.
Number of participants with adverse events
CTCAE Version 4.3
Measured: Baseline and months 2,3,4,5,6,12,18,24
Sleep quality
Self reported VAS scale (0-10)
Measured: Baseline, up to 72 hours after surgery and months 2,3,4,5,6,12,18,24
Cancer recurrence incidence
Measured: participant will be followed for the duration of study, an expected average of 2 years
Progression-free survival
Measured: participant will be followed for the duration of study, an expected average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage II and III Breast 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
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Council of Thailand, Srinagarind Hospital, Khon Kaen University, Maharat Nakhon Ratchasima Hospital, General Drugs House Co.,LTD.
- Responsible party
- Principal investigator, Nutjaree Pratheepawanit Johns, Khon Kaen University
- Investigators
- Nutjaree P Johns, PharmD,PhD, Principal investigator, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557478
- Sponsor's protocol ID
- MIQOL-B
- Acronym
- MIQOL-B
- Status last verified
- Jan 2015
- First submitted
- 13 Mar 2012
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin in Improving the Quality of Life of Breast Cancer Patients and Reduction of Postoperative Pain and Chemotherapy Induced Toxicity
- ClinicalTrials.gov ID
- NCT01557478
- Acronym / sponsor ID
- MIQOL-B / MIQOL-B
- Conditions
- Stage II and III Breast Cancer
- Keywords
- breast cancer, melatonin, adjuvant therapy, quality of life, pain, sleep, survival, adverse events
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Collaborators
- National Research Council of Thailand, Srinagarind Hospital, Khon Kaen University, Maharat Nakhon Ratchasima Hospital, General Drugs House Co.,LTD.
- Study start
- Mar 2012
- Primary completion
- Sep 2016 (estimated)
- First posted
- 19 Mar 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.
The study evaluate the effect of melatonin in improving quality of life and reducing post operative pain and chemotherapy-induced toxicity in breast cancer patients. This is a multi-center, randomized, double-blind, placebo controlled trial conducted in stage II or III breast cancer patients. Mixed-block randomization, stratified by center and treatment scheme is used to divide eligible patients into two groups: melatonin 20 mg or matched placebo. The patients are required to take the studied drugs at night (after 21.00 pm) on the first night prior to surgery and continue for 24 months. Standard treatment is surgery followed by chemotherapy according to each center's standard protocol. Study endpoints are QOL (FACT-B), pain (VAS 0-10), adverse event frequency, sleep quality (VAS 0-10), recurrence rate and progression-free survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Matched placebo | Placebo comparator | Drug: match placeboMatched placebo (identical formulation and delivery, without active ingredient) |
| Melatonin 20mg | Active comparator | Drug: Melatonin20 mg melatonin gelatin capsule |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- histologically proven stage II or III breast 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
Key exclusion criteria (5 listed)
- received prior chemotherapy or biotherapy, radiotherapy or surgery within 1 month preceding randomization,
- had more than one type of cancer or brain metastasis
- moderate neuropathy (CTCAE grade ≥ 2)
- active infection
- 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 |
|---|---|---|
| Melatonin20 mg melatonin gelatin capsule (1) taken orally after 21:00 hours each night throughout the study | Drug | Melatonin 20mg |
| match placeboplacebo gelatin capsule (1) taken orally after 21:00 hours each night throughout the study | Drug | Matched placebo |
Primary outcome
Quality of Life (FACT-B Version 4)
Time frame: Change from baseline in TOI scores at 6 months
Self-reported questionnaire. FACT-B Thai Version 4 has been previously validated. Change from baseline will be evaluated at months 2,4,6,12,18,24.
5 secondary outcomes
Pain and amount of pain medication used
Time frame: Before and up to 72 hours after surgery.
Number of participants with adverse events
Time frame: Baseline and months 2,3,4,5,6,12,18,24
Sleep quality
Time frame: Baseline, up to 72 hours after surgery and months 2,3,4,5,6,12,18,24
Cancer recurrence incidence
Time frame: participant will be followed for the duration of study, an expected average of 2 years
Progression-free survival
Time frame: participant will be followed for the duration of study, an expected average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2015.
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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.
Nutjaree P Johns, PharmD,PhD principal investigator
Khon Kaen University
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 Melatonin in people with Stage II and III Breast 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 10 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Jan 2015. 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?
Results are not available in the source record.
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-B Version 4) (time frame: Change from baseline in TOI scores at 6 months). 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 8 Jan 2015.