Intravenous Ascorbic Acid Supplementation in Neoadjuvant Chemotherapy for Breast Cancer

• Status: Unknown status
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

Forty years ago clinical studies conducted by Ewan Cameron and Linus Pauling suggested that intravenous (IV) and oral ascorbic acid (AA) may diminish symptoms and could improve survival in terminal cancer patients. Previous phase I and II clinical trials have found that high dose (1.5g/kg ) iv AA is well tolerated in cancer patients. This is a phase I/II, randomized study of parenteral administration of Ascorbic Acid (AA) as a supplement to the conventional neo-adjuvant chemotherapy in women with breast cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Academic Emergency County Hospital Sibiu
• Collaborator: CHU-UCL Namur (site Mont-Godinne), Belgium
• Treatments: Ascorbic Acid; Vitamins

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)