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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

Page last updated: August 20, 2015

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