Nutraceuticals Versus Usual Care in the Prevention or Reduction of CIPN in Patients Treated With Docetaxel as Neoadjuvant/Adjuvant Breast Cancer Therapy (CIPN)
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|ClinicalTrials.gov Identifier: NCT02795572|
Recruitment Status : Terminated (Retirement of the Principal Investigator)
First Posted : June 10, 2016
Last Update Posted : July 5, 2019
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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 ]
- Association of specific SNPs to CIPN [ Time Frame: 24 months ]
- Association of SNPs and Therapeutic response [ Time Frame: 24 months ]
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
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G1Z2|
|Principal Investigator:||Katia Tonkin, MD||AHS Cancer Control Alberta|