NCT02795572

Nutraceuticals Versus Usual Care in the Prevention or Reduction of CIPN in Patients Treated With Docetaxel as Neoadjuvant/Adjuvant Breast Cancer Therapy

Protocol Comparing a Nutraceutical Formulation Consisting of Omega-3 Fatty Acids, Vitamin D, and Vitamins B6 Plus B12 Versus No Treatment in the Prevention or Reduction of Chemotherapy Induced Peripheral Neuropathy (CIPN) in Patients Treated With Docetaxel as Neoadjuvant/Adjuvant Breast Cancer Therapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: AHS Cancer Control Alberta · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Peripheral Neuropathy in Breast Cancer Patient

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D	Vitamin D 2000 IU oral once daily
DIETARY_SUPPLEMENT	Vitamin B6	Vitamin B6 100 mg oral once daily
DIETARY_SUPPLEMENT	Vitamin B12	Vitamin B12 100 mcg oral once daily
DIETARY_SUPPLEMENT	Omega-3 Fatty Acids	Omega-3 Fatty Acids 900 mg oral three times a day (600 mg EPA, 300 mg DHA)

Timeline

• Start date: 2017-06-27
• Primary completion: 2017-08-31
• Completion: 2017-08-31
• First posted: 2016-06-10
• Last updated: 2019-07-05

Locations

1 site across 1 country: Canada