Intravenous Ascorbic Acid in Women Receiving Adjuvant or Neo-Adjuvant Chemotherapy for Early Stage Breast Cancer
Information source: Midwestern Regional Medical Center
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fatigue
Intervention: Ascorbic Acid (Drug); Normal Saline (Other)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: Midwestern Regional Medical Center Official(s) and/or principal investigator(s): Dennis Citrin, MD, PhD, Principal Investigator, Affiliation: Midwestern Regional Medical Center
Overall contact: Dennis Citrin, MD, PhD, Phone: 847-872-5892, Email: Dennis.Citrin@CTCA-Hope.com
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Primary outcome: Fatigue by self reported fatigue inventory questionnaire
Secondary outcome: Fatigue ( EORTC QLQ-FA13)Fatigue ( EORTC QLQ-FA13) Fatigue ( EORTC QLQ-FA13) Fatigue by self reported fatigue inventory questionnaire Fatigue by self reported fatigue inventory questionnaire
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Dennis Citrin, MD, PhD, Phone: 847-872-5892, Email: Dennis.Citrin@CTCA-Hope.com Additional Information
Starting date: September 2015
Last updated: August 7, 2015
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