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

Peripheral Neuropathy in Breast Cancer Patient Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02795572
• Other study ID #: CIPNN-SMG-CCI-01
• Status: Terminated
• Phase: Phase 2
• Start date: June 27, 2017
• Est. completion date: August 31, 2017

Study information

• Verified date: July 2019
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Peripheral Nervous System Diseases
• Peripheral Neuropathy in Breast Cancer Patient

Intervention

Dietary Supplement:
• Vitamin D
Vitamin D 2000 IU oral once daily
• Vitamin B6
Vitamin B6 100 mg oral once daily
• Vitamin B12
Vitamin B12 100 mcg oral once daily
• Omega-3 Fatty Acids
Omega-3 Fatty Acids 900 mg oral three times a day (600 mg EPA, 300 mg DHA)

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Association of specific SNPs to CIPN		24 months
Other	Association of SNPs and Therapeutic response		24 months
Primary	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	Delay in the onset of grade 1 or decrease in the severity of CIPN		12 months after initiation of chemotherapy
Secondary	Affect of Usage of Nutraceuticals on Response to treatment		24 months