Melatonin and Vitamin D in Breast Cancer

Last updated: November 7, 2014
Sponsor: Hamilton Health Sciences Corporation
Overall Status: Active - Recruiting

Phase

2

Condition

Cancer

Breast Cancer

Treatment

N/A

Clinical Study ID

NCT02288806
MELO-D
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  • Planned to undergo definitive surgery, either lumpectomy or mastectomy in 3 or moreweeks

Exclusion

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 ofthe 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 otherinvestigational agent

  • Unwilling or unable to provide informed consent

Study Design

Total Participants: 144
Study Start date:
September 01, 2013
Estimated Completion Date:
September 30, 2015

Study 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.

Connect with a study center

  • Juravinski Cancer Center

    Hamilton, Ontario L8V 1C3
    Canada

    Active - Recruiting

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario L8N 4A6
    Canada

    Active - Recruiting

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