We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified August 2017 by AHS Cancer Control Alberta
Sponsor:
ClinicalTrials.gov Identifier:
NCT02795572
First Posted: June 10, 2016
Last Update Posted: August 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
AHS Cancer Control Alberta
  Purpose
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).

Condition Intervention Phase
Peripheral Neuropathy in Breast Cancer Patient Dietary Supplement: Vitamin D Dietary Supplement: Vitamin B6 Dietary Supplement: Vitamin B12 Dietary Supplement: Omega-3 Fatty Acids Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • Chemotherapy Induced Peripheral Neuropathy Assessment [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures:
  • Delay in the onset of grade 1 or decrease in the severity of CIPN [ Time Frame: 12 months after initiation of chemotherapy ]
  • Affect of Usage of Nutraceuticals on Response to treatment [ Time Frame: 24 months ]

Other Outcome Measures:
  • Association of specific SNPs to CIPN [ Time Frame: 24 months ]
  • Association of SNPs and Therapeutic response [ Time Frame: 24 months ]

Estimated Enrollment: 106
Actual Study Start Date: June 27, 2017
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Group
The intervention group will receive a daily dose of Vitamin D 2000 IU, Vitamin B6 100 mg, Vitamin B12 100 mcg and Omega-3 Fatty Acids 2700 mg [900 mg TID (600 mg EPA, 300 mg DHA)].
Dietary Supplement: Vitamin D
Vitamin D 2000 IU oral once daily
Dietary Supplement: Vitamin B6
Vitamin B6 100 mg oral once daily
Dietary Supplement: Vitamin B12
Vitamin B12 100 mcg oral once daily
Dietary Supplement: Omega-3 Fatty Acids
Omega-3 Fatty Acids 900 mg oral three times a day (600 mg EPA, 300 mg DHA)
No Intervention: Reference Group
Reference group will receive usual care.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02795572


Contacts
Contact: Katia Tonkin, MD 780-432-8514 Katia.Tonkin@albertahealthservices.ca

Locations
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Katia Tonkin, MD AHS Cancer Control Alberta
  More Information

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT02795572     History of Changes
Other Study ID Numbers: CIPNN-SMG-CCI-01
First Submitted: May 30, 2016
First Posted: June 10, 2016
Last Update Posted: August 16, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AHS Cancer Control Alberta:
Breast Neoplasms
Peripheral Neuropathies

Additional relevant MeSH terms:
Breast Neoplasms
Peripheral Nervous System Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neuromuscular Diseases
Nervous System Diseases
Vitamins
Vitamin D
Ergocalciferols
Vitamin B 12
Hydroxocobalamin
Vitamin B 6
Pyridoxal
Pyridoxine
Docetaxel
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hematinics