Melatonin and Vitamin D in Breast Cancer

Breast Cancer Clinical Trial

— MELO-D  

Official title:

Anti-proliferative Effects of Melatonin and Vitamin D in Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02288806
• Other study ID #: MELO-D
• Status: Recruiting
• Phase: Phase 2
• First received: November 4, 2014
• Last updated: November 7, 2014
• Start date: September 2013
• Est. completion date: September 2015

Study information

• Verified date: November 2014
• Source: Hamilton Health Sciences Corporation
• Contact: Punam Rana, MD
• Phone: 9055272299
• Email: punam.rana[@]jcc.hhsc.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The investigators want to study whether Vitamin D and melatonin can reduce the growth of cancer cells in women with breast cancer. Studies using cell cultures and animals have shown that Vitamin D can reduce the spread of cancer. Studies in people have shown that exposure to sun and eating foods containing high levels of Vitamin D can protect against cancer. As well, researchers have noticed that an increase in melatonin levels appears to lower the risk of getting cancer. Melatonin is a hormone secreted by the body during the night while sleeping.

Women with cancer proven by breast biopsy who are planned for surgery will be included. The investigators want to see if treatment with Vitamin D (2000 IU daily), or melatonin (20 mg daily), or both pills together, reduces the growth of cancer cells when compared to treatment with sugar pills. All women will receive identical appearing pills for approximately four weeks. The investigators will measure a tumour protein called Ki67 in the biopsy and in the tumour removed at surgery. Ki67 provides information on how rapidly the cancer grows. The reduction in Ki67 levels between the biopsy and surgery will be compared between the four groups.

Vitamin D and melatonin are inexpensive with few side effects. If a reduction in cancer growth rate is shown then this would provide a strong reason for further large cancer prevention trials with Vitamin D and melatonin.

Description:

This study aims to investigate the effects of Vitamin D and melatonin on breast cancer proliferation in a randomized trial. Both agents have been associated with anti-cancer action in both epidemiological and experimental studies. However, there has been some discrepancy observed in evidence supporting their preventive function in population and clinical studies, likely related to a lack of knowledge on the exact preventive activity. Our proposed study is the first to use an innovative pre-operative chemoprevention approach. The investigators hypothesize that supplementation with Vitamin D and separately melatonin decreases the proliferative activity in breast cancer lesions. The investigators will evaluate whether treatment with Vitamin D (2000 IU/day) or melatonin (20 mg/day) reduces tumour proliferation compared to placebo, as measured by Ki67. A factorial design will be used where 144 women who have biopsy-proven breast cancer will be randomized to: a) Vitamin D, b) melatonin, c) both or d) placebo prior to their surgery. Treatment will be for approximately four weeks. The Ki67 marker will be measured on the tumour tissue. Change in Ki67 scores between the biopsy and surgery will be compared between the four groups. Blood samples will also be collected and studied at a later time on the mechanisms of action of Vitamin D and melatonin. The proposed study is innovative in its approach and content and has the potential to deeply improve strategies for cancer prevention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Melatonin
Melatonin 20mg once daily by mouth
• Vitamin D
Vitamin D 2000 IU once daily by mouth
• Placebo
Placebo pill taken once daily by mouth

Locations

Country	Name	City	State
Canada	Juravinski Cancer Center	Hamilton	Ontario
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proliferation rate	Ki67 will be used as the marker of proliferation. This is expressed as the percentage of tumour cells expressing Ki67. This will be measured using anti-human Ki67 monoclonal antibody SP6. Ki67 will be measured on the original core biopsy (pre-treatment) and on the lumpectomy/mastectomy specimen (post-treatment).	At the time of surgery. Results obtained 2 weeks after surgery on average	No
Secondary	MicroRNA	Change in plasma microRNA will be assessed at the time of surgery compared to time of biopsy.	At the time of surgery. Results obtained 2 weeks after surgery on average	No