Clinical trial NCT02795572: Nutraceuticals Versus Usual Care in the Prevention or Reduction of CIPN in Patients Treated With Docetaxel as Neoadjuvant/Adjuvant Breast Cancer Therapy
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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Peripheral Neuropathy in Breast Cancer Patient
Keywords: Breast Neoplasms
Peripheral Neuropathies
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2016-06-10
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Chemotherapy Induced Peripheral Neuropathy Assessment
timeFrame: 12 months
Secondary outcomes:
measure: Delay in the onset of grade 1 or decrease in the severity of CIPN
timeFrame: 12 months after initiation of chemotherapy
measure: Affect of Usage of Nutraceuticals on Response to treatment
timeFrame: 24 months
Other outcomes:
measure: Association of specific SNPs to CIPN
timeFrame: 24 months
measure: Association of SNPs and Therapeutic response
timeFrame: 24 months
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Katia Tonkin, MD
role: PRINCIPAL_INVESTIGATOR
References: