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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02795572

Acronym

CIPN

Enrollment

Registered

2016-06-10

Start date

2017-06-27

Completion date

2017-08-31

Last updated

2019-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Neuropathy in Breast Cancer Patient

Keywords

Breast Neoplasms, Peripheral Neuropathies

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.

Interventions

DIETARY_SUPPLEMENTVitamin D

Vitamin D 2000 IU oral once daily

DIETARY_SUPPLEMENTVitamin B6

Vitamin B6 100 mg oral once daily

DIETARY_SUPPLEMENTVitamin B12

Vitamin B12 100 mcg oral once daily

DIETARY_SUPPLEMENTOmega-3 Fatty Acids

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Chemotherapy Induced Peripheral Neuropathy Assessment	12 months	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

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

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026