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Retirement of the Principal Investigator
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | 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)]. |
|
| Reference Group | No Intervention | Reference group will receive usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Dietary Supplement | Vitamin D 2000 IU oral once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Chemotherapy Induced Peripheral Neuropathy Assessment | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Delay in the onset of grade 1 or decrease in the severity of CIPN | 12 months after initiation of chemotherapy | |
| Affect of Usage of Nutraceuticals on Response to treatment | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Association of specific SNPs to CIPN | 24 months | |
| Association of SNPs and Therapeutic response | 24 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katia Tonkin, MD | AHS Cancer Control Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cross Cancer Institute | Edmonton | Alberta | T6G1Z2 | Canada |
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| Vitamin B6 |
| Dietary Supplement |
Vitamin B6 100 mg oral once daily |
|
| Vitamin B12 | Dietary Supplement | Vitamin B12 100 mcg oral once daily |
|
| Omega-3 Fatty Acids | Dietary Supplement | Omega-3 Fatty Acids 900 mg oral three times a day (600 mg EPA, 300 mg DHA) |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D025101 | Vitamin B 6 |
| D014805 | Vitamin B 12 |
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D010847 | Picolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
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