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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-27

Study Completion Date

2017-08-31

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).

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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.

Conditions

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Peripheral Neuropathy in Breast Cancer Patient

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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 \[900 mg TID (600 mg EPA, 300 mg DHA)\].

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Vitamin D 2000 IU oral once daily

Vitamin B6

Intervention Type DIETARY_SUPPLEMENT

Vitamin B6 100 mg oral once daily

Vitamin B12

Intervention Type DIETARY_SUPPLEMENT

Vitamin B12 100 mcg oral once daily

Omega-3 Fatty Acids

Intervention Type DIETARY_SUPPLEMENT

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

Reference Group

Reference group will receive usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vitamin D

Vitamin D 2000 IU oral once daily

Intervention Type DIETARY_SUPPLEMENT

Vitamin B6

Vitamin B6 100 mg oral once daily

Intervention Type DIETARY_SUPPLEMENT

Vitamin B12

Vitamin B12 100 mcg oral once daily

Intervention Type DIETARY_SUPPLEMENT

Omega-3 Fatty Acids

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

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No