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

• Status: Withdrawn
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

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

Details

• Lead Sponsor: Midwestern Regional Medical Center
• Treatments: Ascorbic Acid

Criteria

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