Status:
TERMINATED
Nutraceuticals Versus Usual Care in the Prevention or Reduction of CIPN in Patients Treated With Docetaxel as Neoadjuvant/Adjuvant Breast Cancer Therapy
Lead Sponsor:
AHS Cancer Control Alberta
Conditions:
Peripheral Neuropathy in Breast Cancer Patient
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
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 p...
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 hav...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2017
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT02795572
Start Date
June 27 2017
End Date
August 31 2017
Last Update
July 5 2019
Active Locations (1)
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1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G1Z2