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

NCT ID: NCT02521077

Last Updated: 2017-06-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-31
• Study Completion Date: 2019-03-31

Brief 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.

Conditions

Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Odd Cycle Intravenous Ascorbic Acid

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%).

Group Type: EXPERIMENTAL

Ascorbic Acid

Intervention Type: DRUG

500 g ascorbic acid dissolved in 500 ml sterile water.

Normal Saline

Intervention Type: OTHER

Saline 0.9%

Even Cycle Intravenous Ascorbic Acid

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%).

Group Type: EXPERIMENTAL

Ascorbic Acid

Intervention Type: DRUG

500 g ascorbic acid dissolved in 500 ml sterile water.

Normal Saline

Intervention Type: OTHER

Saline 0.9%

Interventions

Ascorbic Acid

500 g ascorbic acid dissolved in 500 ml sterile water.

Intervention Type: DRUG

Normal Saline

Saline 0.9%

Intervention Type: OTHER

Other Intervention Names

Vitamin C

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Midwestern Regional Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Dennis Citrin, MD

Medical Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dennis Citrin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Midwestern Regional Medical Center

Other Identifiers

MZ2015010

Identifier Type: -

Identifier Source: org_study_id