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

Primary Purpose

Peripheral Neuropathy in Breast Cancer Patient

Status

Terminated

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Vitamin D

Vitamin B6

Vitamin B12

Omega-3 Fatty Acids

About this trial

This is an interventional treatment trial for Peripheral Neuropathy in Breast Cancer Patient focused on measuring Breast Neoplasms, Peripheral Neuropathies

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Cross Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Reference Group

Arm Description

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)].

Reference group will receive usual care.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Delay in the onset of grade 1 or decrease in the severity of CIPN

Affect of Usage of Nutraceuticals on Response to treatment

Full Information

NCT ID

NCT02795572

First Posted

May 30, 2016

Last Updated

July 2, 2019

Sponsor

AHS Cancer Control Alberta

1. Study Identification

Unique Protocol Identification Number

NCT02795572

Brief Title

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

Acronym

CIPN

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Terminated

Why Stopped

Retirement of the Principal Investigator

Study Start Date

June 27, 2017 (Actual)

Primary Completion Date

August 31, 2017 (Actual)

Study Completion Date

August 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AHS Cancer Control Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Neuropathy in Breast Cancer Patient

Keywords

Breast Neoplasms, Peripheral Neuropathies

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Experimental

Arm Description

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)].

Arm Title

Reference Group

Arm Type

No Intervention

Arm Description

Reference group will receive usual care.

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D

Intervention Description

Vitamin D 2000 IU oral once daily

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin B6

Intervention Description

Vitamin B6 100 mg oral once daily

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin B12

Intervention Description

Vitamin B12 100 mcg oral once daily

Intervention Type

Dietary Supplement

Intervention Name(s)

Omega-3 Fatty Acids

Intervention Description

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

Primary Outcome Measure Information:

Title

Chemotherapy Induced Peripheral Neuropathy Assessment

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Delay in the onset of grade 1 or decrease in the severity of CIPN

Time Frame

12 months after initiation of chemotherapy

Title

Affect of Usage of Nutraceuticals on Response to treatment

Time Frame

24 months

Other Pre-specified Outcome Measures:

Title

Association of specific SNPs to CIPN

Time Frame

24 months

Title

Association of SNPs and Therapeutic response

Time Frame

24 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Katia Tonkin, MD

Organizational Affiliation

AHS Cancer Control Alberta

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cross Cancer Institute

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G1Z2

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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