NCT02795572: CIPN

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

Terminated Phase 2 Last updated 5 July 2019

What this trial tests

Phase 2 trial testing Vitamin D in Peripheral Neuropathy in Breast Cancer Patient in 13 participants. Terminated before completion.

Timeline

27 June 2017

Primary endpoint
31 August 2017

31 August 2017

Quick facts

Lead sponsor	AHS Cancer Control Alberta
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	27 June 2017
Primary completion	31 August 2017
Estimated completion	31 August 2017
Sites	1 location across Canada

Drugs / interventions tested

• Vitamin D
• Vitamin B6 — full drug profile →
• Vitamin B12 — full drug profile →
• Omega-3 Fatty Acids — full drug profile →

Conditions studied

• Peripheral Neuropathy in Breast Cancer Patient — all drugs for Peripheral Neuropathy in Breast Cancer Patient →

Sponsor

AHS Cancer Control Alberta — full company profile →

Who can join

Adults 18 to 70, female only, with Peripheral Neuropathy in Breast Cancer Patient. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Omega-3 fatty acids: molecular weapons against chemoresistance in breast cancer.
   Marchio V, Augimeri G, Morelli C, Vivacqua A, et al · · 2025 · cited 11× · PMID 39863855 · DOI 10.1186/s11658-025-00694-x