Intravenous Ascorbic Acid in Women Receiving Adjuvant or Neo-Adjuvant Chemotherapy for Early Stage Breast Cancer

Prospective Double Blind Study of the Effect of Intravenous High Dose Ascorbic Acid in Women Receiving Adjuvant or Neo-Adjuvant Chemotherapy for Early Stage Breast Cancer

This is a parallel-track, randomized study will observe whether intravenous ascorbic acid reduces the reported fatigue in women receiving adjuvant or neo-adjuvant chemotherapy for early stage breast cancer.

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
• Diagnosed early stage breast cancer and scheduled to receive either adjuvant or neo-adjuvant chemotherapy;
• Willing to receive either intravenous ascorbic acid or normal saline;
• Willing to use an acceptable contraceptive method for the duration of the study and for 30 days following the last dose of study drug;
• Negative urine or serum pregnancy test within 2 weeks prior to receipt of study drug;
• Willing to complete all evaluation tools;
• Able to give informed consent to participate in the study; and
• Agree to avoid any additional supplemental ascorbic acid throughout the study.

Exclusion Criteria:

• Diagnosed Glucose-6-phosphate dehydrogenase deficiency;
• Renal insufficiency (Blood Urea Nitrogen >30 mg/dL, or Creatinine >1.5 mg/dL);
• Unwillingness or mental incapacity to complete self-reported questionnaires;
• Active smoker; and
• Male sex