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

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

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).

Study Overview

• Status: Terminated
• Conditions: Peripheral Neuropathy in Breast Cancer Patient
• Intervention / Treatment: Dietary supplement: Vitamin D; Dietary supplement: Vitamin B6; Dietary supplement: Vitamin B12; Dietary supplement: Omega-3 Fatty Acids

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G1Z2
      • Cross Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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; 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)
No Intervention: Reference Group; Reference group will receive usual care.

What is the study measuring?

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	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

Other Outcome Measures

Outcome Measure	Time Frame
Association of specific SNPs to CIPN	24 months
Association of SNPs and Therapeutic response	24 months

Collaborators and Investigators

• Sponsor: AHS Cancer Control Alberta
• Investigators: Principal Investigator: Katia Tonkin, MD, AHS Cancer Control Alberta

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2017
• Primary Completion (Actual): August 31, 2017
• Study Completion (Actual): August 31, 2017

Study Registration Dates

• First Submitted: May 30, 2016
• First Submitted That Met QC Criteria: June 6, 2016
• First Posted (Estimate): June 10, 2016

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Breast Neoplasms; Peripheral Neuropathies
• Additional Relevant MeSH Terms: Nervous System Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Neuromuscular Diseases; Breast Neoplasms; Peripheral Nervous System Diseases; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Hematinics; Vitamin D; Vitamins; Vitamin B 12; Hydroxocobalamin; Vitamin B Complex; Vitamin B 6; Pyridoxal; Pyridoxine
• Other Study ID Numbers: CIPNN-SMG-CCI-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No