TerminatedPhase 2

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

Stopped: Retirement of the Principal Investigator

Canada13 participantsStarted 2017-06-27

Plain-language 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).

Who can participate

Age range18 Years – 70 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Chemotherapy Induced Peripheral Neuropathy Assessment

Timeframe: 12 months

Trial details

NCT IDNCT02795572

SponsorAHS Cancer Control Alberta

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-08-31

View on ClinicalTrials.gov More Peripheral Neuropathy in Breast Cancer Patient trials