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

Midwestern Regional Medical Center

Status and phase: Withdrawn; Phase 2

Conditions: Fatigue

Treatments: Other: Normal Saline; Drug: Ascorbic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02521077

MZ2015010

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Odd Cycle Intravenous Ascorbic Acid

Experimental group

Description:

Women randomized to this study arm will receive intravenous ascorbic acid (50g in 500 ml sterile water) prior to their odd-numbered chemotherapy cycles. During the even-numbered chemotherapy cycles, these subjects will receive intravenous normal saline (0.9%).

Treatment:

Drug: Ascorbic Acid

Other: Normal Saline

Even Cycle Intravenous Ascorbic Acid

Experimental group

Description:

Women randomized to this study arm will receive intravenous ascorbic acid (50g in 500 ml sterile water) prior to their even-numbered chemotherapy cycles. During the odd-numbered chemotherapy cycles, these subjects will receive intravenous normal saline (0.9%).

Treatment:

Drug: Ascorbic Acid

Other: Normal Saline