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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Peripheral Neuropathy in Breast Cancer Patient

Intervention / Treatment
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* Dietary Supplement: Vitamin D
* Dietary Supplement: Vitamin B6
* Dietary Supplement: Vitamin B12
* Dietary Supplement: Omega-3 Fatty Acids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female 18-70 years of age Biopsy proven invasive breast carcinoma Scheduled to receive docetaxel (3-6 cycles) Have values for liver (AST, ALT, Bilirubin) and renal function (CREAT), within 1.5 times normal values as drawn per standard of care. ECOG 0-2 Be able to provide informed consent Willingness to adhere to regimen Exclusion Criteria: Metastatic disease Any peripheral neuropathy Known HIV (testing not required) Diseases causing malabsorption i.e.: Inflammatory Bowel Disease, Celiac and Whipple's Disease Patients with seafood allergies Patients on Warfarin or with a documented clinically significant bleeding disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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)]. | Dietary Supplement: Vitamin D<br>* Vitamin D 2000 IU oral once daily<br>Dietary Supplement: Vitamin B6<br>* Vitamin B6 100 mg oral once daily<br>Dietary Supplement: Vitamin B12<br>* Vitamin B12 100 mcg oral once daily<br>Dietary Supplement: Omega-3 Fatty Acids<br>* Omega-3 Fatty Acids 900 mg oral three times a day (600 mg EPA, 300 mg DHA)<br>|
| No Intervention: Reference Group<br>Reference group will receive usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delay in the onset of grade 1 or decrease in the severity of CIPN |  | 12 months after initiation of chemotherapy | 
| Affect of Usage of Nutraceuticals on Response to treatment |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Neoplasms, Peripheral Neuropathies