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

NCT02795572 | Terminated Phase 2

• 1 other identifier: CIPNN-SMG-CCI-01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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).

Conditions

Peripheral Neuropathy in Breast Cancer Patient

Keywords

Breast Neoplasms; Peripheral Neuropathies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 Outcomes (2)

• Association of specific SNPs to CIPN

  24 months

• Association of SNPs and Therapeutic response

  24 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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; Dietary Supplement: Vitamin B6; Dietary Supplement: Vitamin B12; Dietary Supplement: Omega-3 Fatty Acids

Reference Group

NO INTERVENTION

Reference group will receive usual care.

Interventions

Vitamin D DIETARY_SUPPLEMENT

Vitamin D 2000 IU oral once daily

Intervention Group

Vitamin B6 DIETARY_SUPPLEMENT

Vitamin B6 100 mg oral once daily

Intervention Group

Vitamin B12 DIETARY_SUPPLEMENT

Vitamin B12 100 mcg oral once daily

Intervention Group

Omega-3 Fatty Acids DIETARY_SUPPLEMENT

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

Intervention Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G1Z2, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Peripheral Nervous System Diseases

Interventions

Vitamin D; Vitamin B 6; Vitamin B 12; Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Katia Tonkin, MD

  AHS Cancer Control Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2016
• First Posted: June 10, 2016
• Study Start: June 27, 2017
• Primary Completion: August 31, 2017
• Study Completion: August 31, 2017
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)