Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 75 of 1121 for:    Oral Cancer | ( Map: Canada )

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

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02795572
Recruitment Status : Terminated (Retirement of the Principal Investigator)
First Posted : June 10, 2016
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta

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).

Condition or disease Intervention/treatment 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

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
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
Actual Study Start Date : June 27, 2017
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : August 31, 2017


Arm Intervention/treatment
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.



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

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


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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

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


Locations
Layout table for location information
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Layout table for investigator information
Principal Investigator: Katia Tonkin, MD AHS Cancer Control Alberta

Layout table for additonal information
Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT02795572     History of Changes
Other Study ID Numbers: CIPNN-SMG-CCI-01
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Peripheral Nervous System Diseases
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
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hematinics