Early Stage Breast CancerPhase 2MELO-DNCT01965522
Anti-proliferative Effects of Vitamin D and Melatonin in Breast Cancer
A Phase 2 study testing Melatonin and Vitamin D in people with Early Stage Breast Cancer, run by Juravinski Cancer Center at 2 sites in Canada.
Trial summary
Investigators plan to carry out a study to investigate two different pills, Vitamin D and melatonin, and whether they can reduce the spread of cancer cells in the tumors of women with breast cancer. These pills are inexpensive and have very few side effects. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early Stage Breast Cancer
- What is being tested?
- Melatonin and Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2013to May 2017
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman with histologically confirmed invasive breast cancer (ductal, lobular, or mixed)
- Planned to undergo definitive surgery, either lumpectomy or mastectomy in 3 or more weeks
Who cannot join
- Less than 18 years of age
- Stage IIIB or IV disease
- Inoperable locally advanced or metastatic breast cancer
- Neoadjuvant chemotherapy is intended
- Currently taking vitamin D supplements
- Currently taking melatonin supplements
Show all 15Show fewer
- Previously taking vitamin D or melatonin supplements within the last 3 months
- Currently taking a multivitamin and not willing to discontinue for the duration of the study
- Hyperparathyroid disease or other calcium disturbance in the past five years
- Active renal stones in the last six months
- Renal failure (creatinine > 190 mmol/L)
- Hypercalcemia (serum calcium > 2.6 mmol/L)
- Known pregnancy
- Participation in another clinical trial where the patient receives any other investigational product
- Unwilling or unable to provide informed consent
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 1Y3
Juravinski Cancer Center
Hamilton, Ontario, L8V 1C3
About this study
Investigators plan to carry out a study to investigate two different pills, Vitamin D and melatonin, and whether they can reduce the spread of cancer cells in the tumors of women with breast cancer. These pills are inexpensive and have very few side effects. A large number of studies using cell cultures and animals have shown that both vitamin D and melatonin can help destroy breast cancer cells. However thoughtful and well-designed studies are necessary on humans to see if they can decrease the spread of breast cancer, and possibly even prevent breast cancer. The proposed study aims to understand the anti-cancer activity of vitamin D and melatonin. This knowledge will assist in creating efficient cancer prevention strategies for Canadians. This study will include women with breast cancer who are being planned for surgery, and will assess whether treatment with vitamin D (dose of 2000 IU per day) in a group of 36 women, or melatonin (dose of 20mg per day) in another group of 36 women, or both pills together in yet another group of 36 women, reduces the spread of cancer cells when compared to a fourth group of 36 women who are treated with sugar pills. To do this we will measure a substance in the blood called Ki67, which provides information about the spread of cancer. Investigators will compare the Ki67 levels in the 4 groups, and all women will receive identical appearing pills so they will not know which treatment they received.
- Conditions
- Early Stage Breast Cancer
- Keywords
- Breast cancer, melatonin, vitamin d, ki67
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Melatonin 20mg taken orally once daily. This is in the form of one capsule which contains two pills of melatonin, 10 mg each.
Vitamin DDrug
Vitamin D 2000 IU taken orally once daily. This is in the form of one capsule which contains two pills of vitamin D, 1000 IU each.
Placebo (melatonin)Drug
Overencapsulated placebo capsule which contains an inert substance. The capsule appears identical to the capsule which contains melatonin tablets.
Placebo (vitamin D)Drug
Overencapsulated placebo capsule which contains an inert substance. The capsule appears identical to the capsule which contains vitamin D tablets.
| Study group | Role | What they receive |
|---|---|---|
| Melatonin and Vitamin D | Experimental | Not described Receives: Drug: Melatonin; Drug: Vitamin D |
| Placebo and Vitamin D | Experimental | Not described Receives: Drug: Vitamin D; Drug: Placebo (melatonin) |
| Melatonin and Placebo | Experimental | Not described Receives: Drug: Melatonin; Drug: Placebo (vitamin D) |
| Placebo and Placebo | Placebo comparator | Not described Receives: Drug: Placebo (melatonin); Drug: Placebo (vitamin D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ki67
The primary outcome is the difference in proliferation rate of Ki67 in the tumour (expressed as the percentage of tumour cells expressing Ki67). Ki67 will be measured on the original core biopsy (pre-treatment) and on the lumpectomy/mastectomy specimen (post-treatment).
Measured: From time of initial biopsy to the final surgery, which is on average 4 weeks
Secondary outcomes (1)
microRNA
Change in serum profile of microRNA at the time of surgery (lumpectomy or mastectomy, post-treatment) will be compared to the time of initial biopsy (pre-treatment).
Measured: At the time of surgery compared to time of biopsy, which is on average 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionAug 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Stage 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juravinski Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Punam Rana, Juravinski Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965522
- Sponsor's protocol ID
- MELO-D
- Acronym
- MELO-D
- Status last verified
- Jun 2017
- First submitted
- 11 Oct 2013
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-proliferative Effects of Vitamin D and Melatonin in Breast Cancer
- ClinicalTrials.gov ID
- NCT01965522
- Acronym / sponsor ID
- MELO-D / MELO-D
- Conditions
- Early Stage Breast Cancer
- Keywords
- Breast cancer, melatonin, vitamin d, ki67
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Juravinski Cancer CenterUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 18 Oct 2013 (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.
Investigators plan to carry out a study to investigate two different pills, Vitamin D and melatonin, and whether they can reduce the spread of cancer cells in the tumors of women with breast cancer. These pills are inexpensive and have very few side effects. A large number of studies using cell cultures and animals have shown that both vitamin D and melatonin can help destroy breast cancer cells. However thoughtful and well-designed studies are necessary on humans to see if they can decrease the spread of breast cancer, and possibly even prevent breast cancer. The proposed study aims to understand the anti-cancer activity of vitamin D and melatonin. This knowledge will assist in creating efficient cancer prevention strategies for Canadians. This study will include women with breast cancer who are being planned for surgery, and will assess whether treatment with vitamin D (dose of 2000 IU per day) in a group of 36 women, or melatonin (dose of 20mg per day) in another group of 36 women, or both pills together in yet another group of 36 women, reduces the spread of cancer cells when compared to a fourth group of 36 women who are treated with sugar pills. To do this we will measure a substance in the blood called Ki67, which provides information about the spread of cancer. Investigators will compare the Ki67 levels in the 4 groups, and all women will receive identical appearing pills so they will not know which treatment they received.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Melatonin and Vitamin D | Experimental | Drug: Melatonin, Drug: Vitamin D |
| Placebo and Vitamin D | Experimental | Drug: Vitamin D, Drug: Placebo (melatonin) |
| Melatonin and Placebo | Experimental | Drug: Melatonin, Drug: Placebo (vitamin D) |
| Placebo and Placebo | Placebo comparator | Drug: Placebo (melatonin), Drug: Placebo (vitamin D) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Woman with histologically confirmed invasive breast cancer (ductal, lobular, or mixed)
- Planned to undergo definitive surgery, either lumpectomy or mastectomy in 3 or more weeks
Key exclusion criteria (15 listed)
- Less than 18 years of age
- Stage IIIB or IV disease
- Inoperable locally advanced or metastatic breast cancer
- Neoadjuvant chemotherapy is intended
- Currently taking vitamin D supplements
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 |
|---|---|---|
| MelatoninMelatonin 20mg taken orally once daily. This is in the form of one capsule which contains two pills of melatonin, 10 mg each. | Drug | Melatonin and Placebo, Melatonin and Vitamin D |
| Vitamin DVitamin D 2000 IU taken orally once daily. This is in the form of one capsule which contains two pills of vitamin D, 1000 IU each. | Drug | Melatonin and Vitamin D, Placebo and Vitamin D |
| Placebo (melatonin)Overencapsulated placebo capsule which contains an inert substance. The capsule appears identical to the capsule which contains melatonin tablets. | Drug | Placebo and Placebo, Placebo and Vitamin D |
| Placebo (vitamin D)Overencapsulated placebo capsule which contains an inert substance. The capsule appears identical to the capsule which contains vitamin D tablets. | Drug | Melatonin and Placebo, Placebo and Placebo |
Primary outcome
Ki67
Time frame: From time of initial biopsy to the final surgery, which is on average 4 weeks
The primary outcome is the difference in proliferation rate of Ki67 in the tumour (expressed as the percentage of tumour cells expressing Ki67). Ki67 will be measured on the original core biopsy (pre-treatment) and on the lumpectomy/mastectomy specimen (post-treatment).
1 secondary outcome
microRNA
Time frame: At the time of surgery compared to time of biopsy, which is on average 4 weeks
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 16 Jun 2017.
Related trials for Early Stage Breast Cancer
RecruitingObservational study
A Study to Assess Treatment Patterns and Treatment Adherence in Early HER2-positive Breast Cancer Participants After Treatment Decentralization
Early-stage HER2+ Breast Cancer
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer
RecruitingPhase 2
BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer
Breast Cancer Invasive, Early-stage Breast Cancer
Active, not recruitingObservational study
Longitudinal ctDNA Surveillance for Older Women With ER+ Breast Cancer Who Omit Surgery
Breast Cancer
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
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 study testing Melatonin and Vitamin D in people with Early Stage Breast Cancer, run by Juravinski Cancer Center at 2 sites in Canada.
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 2 inclusion and 15 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 16 Jun 2017. 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 Canada. 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 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.
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?
Ki67 (time frame: From time of initial biopsy to the final surgery, which is on average 4 weeks). 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 16 Jun 2017.