Melatonin and Vitamin D in Breast Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02288806
• Date of registration: 04/11/2014
• Prospective Registration: No
• Primary sponsor: Hamilton Health Sciences Corporation
• Public title: Melatonin and Vitamin D in Breast Cancer MELO-D
• Scientific title: Anti-proliferative Effects of Melatonin and Vitamin D in Breast Cancer
• Date of first enrolment: September 2013
• Target sample size: 144
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02288806
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Canada

Contacts

• Name: Punam Rana, MD

• Name: Punam Rana, MD
• Affiliation: Hamilton Health Sciences Corporation

Key inclusion & exclusion criteria

Inclusion Criteria:

- Histologically confirmed invasive breast cancer (ductal, lobular, or mixed)

- Planned to undergo definitive surgery, either lumpectomy or mastectomy in 3 or more
weeks

Exclusion Criteria:

- Less than 18 years of age

- Stage IIIB or IV disease

- Inoperable or locally advanced or metastatic breast cancer

- Neoadjuvant chemotherapy is intended

- Currently taking vitamin D supplements

- Currently taking melatonin supplements

- Previously taking vitamin D or melatonin supplements in the last 3 months

- Currently taking a multivitamin and not willing to discontinue for the duration of
the study (i.e., until definitive surgery)

- Hyperparathyroid disease or other calcium disturbances in the past five years

- Active renal stones in the last six months

- Renal failure (creatinine >190 mmol/L in females and >200 mmol/L in males)

- Known pregnancy

- Participation in another clinical trial where the patient receives any other
investigational agent

- Unwilling or unable to provide informed consent



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Drug: Placebo

Drug: Vitamin D

Drug: Melatonin

Primary Outcome(s)

Proliferation rate [Time Frame: At the time of surgery. Results obtained 2 weeks after surgery on average]

Secondary Outcome(s)

MicroRNA [Time Frame: At the time of surgery. Results obtained 2 weeks after surgery on average]

Secondary ID(s)

MELO-D

Source(s) of Monetary Support

Please refer to primary and secondary sponsors