Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Nervous System Diseases

Breast Neoplasms

Peripheral Nervous System Diseases

Breast Diseases

Skin Diseases

Neuromuscular Diseases

Antineoplastic Agents

All Drugs and Chemicals

Bone Density Conservation Agents

Micronutrients

Hematinics

Other Dietary Supplements

Vitamins

Docetaxel

Vitamin D

Cholecalciferol

Vitamin B 6

Pyridoxal

Pyridoxine

Vitamin B Complex

Vitamin B 12

Hydroxocobalamin

Folic Acid

Trace Elements

Omega 3 Fatty Acid

Vitamin D3

Calciferol

Vitamin B6

Methylcobalamin

Vitamin B12

Cobalamin

Cyanocobalamin

Folate

Vitamin B9

The intervention group will receive a daily dose of Vitamin D 2000 IU, Vitamin B6 100 mg, Vitamin B12 100 mcg and Omega-3 Fatty Acids 2700 mg \[900 mg TID (600 mg EPA, 300 mg DHA)\].

Omega-3 Fatty Acids 900 mg oral three times a day (600 mg EPA, 300 mg DHA)

Omega-3 Fatty Acids

Katia Tonkin, MD

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.

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

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.

AHS Cancer Control Alberta

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nutraceuticals Versus Usual Care in the Prevention or Reduction of CIPN in Patients Treated With Docetaxel as Neoadjuvant/Adjuvant Breast Cancer Therapy	NCT02795572	Peripheral Neur...	Vitamin D Vitamin B6 Vitamin B12 Omega-3 Fatty A...	18 Years - 70 Years	AHS Cancer Control Alberta
Nutraceuticals Versus Usual Care in the Prevention or Reduction of CIPN in Patients Treated With Docetaxel as Neoadjuvant/Adjuvant Breast Cancer Therapy	NCT02795572	Peripheral Neur...	Vitamin D Vitamin B6 Vitamin B12 Omega-3 Fatty A...	18 Years - 70 Years	AHS Cancer Control Alberta
Nutraceuticals Versus Usual Care in the Prevention or Reduction of CIPN in Patients Treated With Docetaxel as Neoadjuvant/Adjuvant Breast Cancer Therapy	NCT02795572	Peripheral Neur...	Vitamin D Vitamin B6 Vitamin B12 Omega-3 Fatty A...	18 Years - 70 Years	AHS Cancer Control Alberta

Spots Global Cancer Trial Database for peripheral neuropathy in breast cancer patient