The trial will utilize Nutraceuticals (Vitamin D 2000IU oral once daily, Vitamin B6 100 mg oral once daily, Vitamin B12 100 mcg oral once daily, Omega-3 Fatty Acids 900 mg oral three times a day) in patients treated with Docetacel as Neoadjuvant or Adjuvant Breast cancer Therapy. The trial is being conducted to see if the use of Nutraceuticals will prevent or reduce Chemotherapy Induced Peripheral Neuropathy (CIPN).
Phase 2, Single Centre, Open-label 2 Arm Randomized Trial. The intervention group will receive a daily dose of Vitamin D, Omega-3-fatty acids, Vitamin B6, and Vitamin B12. The reference group will have usual care. Dose of Nutraceuticals: Vitamin D 2000 IU oral once daily, Vitamin B6 100 mg oral once daily, Vitamin B12 100 mcg oral once daily, Omega-3 Fatty Acids 900 mg oral three times a day (600 mg EPA, 300 mg DHA) Population: Breast Cancer patients undergoing either neoadjuvant or adjuvant therapy with docetaxel. 106 participants in total will be needed with accrual being completed in hopefully 1 years' time. Study Investigators will screen the candidates for the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Vitamin D 2000 IU oral once daily
Vitamin B6 100 mg oral once daily
Vitamin B12 100 mcg oral once daily
Cross Cancer Institute
Edmonton, Alberta, Canada
Chemotherapy Induced Peripheral Neuropathy Assessment
To determine if there is a reduction in either severity or incidence of CIPN in patients treated with docetaxel in the female breast cancer population by using a nutraceutical formulation of the investigators design.
Time frame: 12 months
Delay in the onset of grade 1 or decrease in the severity of CIPN
Time frame: 12 months after initiation of chemotherapy
Affect of Usage of Nutraceuticals on Response to treatment
Time frame: 24 months
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Omega-3 Fatty Acids 900 mg oral three times a day (600 mg EPA, 300 mg DHA)