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

Phase 2

Withdrawn

• Conditions: Fatigue
• Interventions: Drug: Ascorbic Acid; Other: Normal Saline

• Registration Number: NCT02521077
• Lead Sponsor: Midwestern Regional Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-27
• Study First Submitted QC: 2015-08-07
• Study First Posted: 2015-08-13
• Study Start: 2017-05
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-23
• Last Update Posted: 2017-06-27
• Primary Completion: 2019-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Even Cycle Intravenous Ascorbic Acid	Normal Saline	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%).
Odd Cycle Intravenous Ascorbic Acid	Normal Saline	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%).
Odd Cycle Intravenous Ascorbic Acid	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%).
Even Cycle Intravenous Ascorbic Acid	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%).

Primary Outcome Measures

Name	Time	Method
Fatigue by self reported fatigue inventory questionnaire	Day 8 of each 4-week treatment cycle.	Patients will complete the validated questionnaire Fatigue Symptom Inventory (FSI)

Secondary Outcome Measures

Name	Time	Method
Fatigue ( EORTC QLQ-FA13)	Day 15 of each 4-week treatment cycle.	Patients will complete the validated questionnaire EORTC QLQ-FA13
Fatigue by self reported fatigue inventory questionnaire	Day 15 of each 4-week treatment cycle.	Patients will complete the validated questionnaire Fatigue Symptom Inventory (FSI)