Clinical Trials Logo
  1. Home
  2. Early-Stage Breast Cancer
  3. NCT01965522

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

Early Stage Breast Cancer Clinical Trial

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

Clinical 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. 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01965522
Study type Interventional
Source Juravinski Cancer Center
Contact
Status Completed
Phase Phase 2
Start date October 2013
Completion date May 2017
View Details
See also
  Status Clinical Trial Phase
Completed NCT02816164 - A Study to Compare Administration Schedules of G-CSF (Filgrastim) for Primary Prophylaxis of Febrile Neutropenia Phase 4
Completed NCT02816112 - Granulocyte-colony Stimulating Factors or Antibiotics for Primary Prophylaxis for Febrile Neutropenia Phase 4
Completed NCT03946683 - Cyberknife for Early Stage Breast Cancer N/A
Recruiting NCT04458532 - Exercise Therapy to Improve Cardiovascular Health in Post-Menopausal Women After Treatment for Early Stage Breast Cancer N/A
Completed NCT01162200 - Cyberknife® Partial Breast Irradiation (PBI) for Early Stage Breast Cancer Phase 1
Completed NCT00309569 - Randomized Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment in Receptor-negative Patients Phase 3
Terminated NCT01545648 - Pilot Study to Evaluate the Impact of Denosumab on Disseminated Tumor Cells (DTC) in Patients With Early Stage Breast Cancer Phase 2
Completed NCT02428114 - A Multi Centre Study to Determine the Feasibility of Using an Integrated Consent Model to Compare Standard of Care Administration Schedules of G-CSF (Filgrastim) for Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia in Early Stage Breast Cancer (React-G Study) N/A
Active, not recruiting NCT02685332 - Phase I Dose Escalation of Single Fraction Adjuvant Stereotactic Body Partial Breast Irradiation Early Stage Breast CA Phase 1
Completed NCT02159157 - A Randomized, Controlled Trial to Determine the Effects of an Exercise Intervention on Physical Activity During Chemotherapy for Patients With Early Stage Breast Cancer N/A
Completed NCT01871116 - POWER-remote Weight Loss Program in Early Stage Breast Cancer N/A
Terminated NCT01166581 - Impact of Breast Magnetic Resonance Imaging (MRI) on Mastectomy Rates N/A
Recruiting NCT06311357 - Percent Weight Change in the Medical Supplement Group of Early Breast Cancer N/A
Terminated NCT02364960 - Targeted Intraoperative Therapy Registry at Bethesda North Hospital (TARGIT)
Active, not recruiting NCT03561454 - A Registry of Intra-Operative Radiation Therapy (IORT) Using the Xoft ® Axxent ® eBx ™ System Patients
Completed NCT02485678 - A Pragmatic Trial of Ambulatory Toxicity Management in Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy for Early Stage Breast Cancer N/A
Active, not recruiting NCT02297672 - Partial Breast Irradiation Using Interstitial Permanent Palladium-103 Seed Implant N/A
Completed NCT02335671 - Evaluating Mass Spectrometry And Intraoperative MRI In The Advanced Multimodality Image Guided Operating Suite (Amigo) In Breast-Conserving Therapy N/A
Completed NCT03102307 - Registry Trial to Evaluate the Clinical Utilization of Targeted Axillary Dissection (TAD)
Recruiting NCT04607473 - ABUS for Early-stage Breast Cancer N/A