Intravenous Ascorbic Acid Supplementation in Neoadjuvant Chemotherapy for Breast Cancer
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, ascorbic acid, vitamin C, vitamin supplementation, quality of life
Eligibility Criteria
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
- Diagnosed high-risk breast cancers (tumours ≥ 2cm and/or locally advanced breast tumors) and scheduled to receive neoadjuvant chemotherapy;
- Agree to avoid any additional supplemental ascorbic acid throughout the study;
- Normal glucose-6- phosphate dehydrogenase (G6PD) activity;
- Normal renal function (serum creatinine ≤ 1.2 mg/dl) and normal liver function;
- No evidence of urolithiasis;
- No evidence of chronic hemodialysis, iron overload (serum ferritin 500 ng/ml);
- Not pregnant or lactating women
Exclusion Criteria:
- Important psychosomatic diseases or known gastrointestinal disorders (ulcer, gastritis, colitis, ileitis);
- Current smoking and/or alcohol consumption ≥ 3UI per day;
- Current use of the following drugs:
Aspirin (exceeding 325 mg/day) Acetaminophen (exceeding 2 g/day) Glutathione Vitamin D (important doses)
Sites / Locations
- Academic Emergency County Hospital Sibiu
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Vitamin C Supplement
Placebo
Ascorbic Acid (AA) with neoadjuvant chemotherapy. Participants received an initial loading dose of 1,5 g Ascorbic Acid (i.v in 100 ml sterile water) on Day 1 followed by 0,75g Ascorbic Acid (i.v in 100 ml sterile water) on Day 2-4 at each chemotherapy cycle and concomitant neoadjuvant chemotherapy regimens administered at the choice of treating physician. Ascorbic Acid is administered intravenously before neoadjuvant therapy in D1
Placebos (normal saline (0.9%) with neoadjuvant chemotherapy. 100 ml normal saline 0.9% (placebo) will be administered (i.v) by the same scheme as Ascorbic Acid on Day 1 and respectively Day 2-4 at each chemotherapy cycle. Concomitant neoadjuvant chemotherapy regimens administered at the choice of treating physician.