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

June 23, 2017 updated by: Dennis Citrin, MD, Midwestern Regional Medical Center

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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%).
Drug: Ascorbic Acid
500 g ascorbic acid dissolved in 500 ml sterile water.
Other Names:
  • Vitamin C
Other: Normal Saline
Saline 0.9%
Experimental: 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%).
Drug: Ascorbic Acid
500 g ascorbic acid dissolved in 500 ml sterile water.
Other Names:
  • Vitamin C
Other: Normal Saline
Saline 0.9%

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue ( EORTC QLQ-FA13)
Time Frame: Day 1 of each 4-week treatment cycle.
Patients will complete the validated questionnaire EORTC QLQ-FA13
Day 1 of each 4-week treatment cycle.
Fatigue ( EORTC QLQ-FA13)
Time Frame: Day 8 of each 4-week treatment cycle.
Patients will complete the validated questionnaire EORTC QLQ-FA13
Day 8 of each 4-week treatment cycle.
Fatigue ( EORTC QLQ-FA13)
Time Frame: Day 15 of each 4-week treatment cycle.
Patients will complete the validated questionnaire EORTC QLQ-FA13
Day 15 of each 4-week treatment cycle.
Fatigue by self reported fatigue inventory questionnaire
Time Frame: Day 1 of each 4-week treatment cycle.
Patients will complete the validated questionnaire Fatigue Symptom Inventory (FSI)
Day 1 of each 4-week treatment cycle.
Fatigue by self reported fatigue inventory questionnaire
Time Frame: Day 15 of each 4-week treatment cycle.
Patients will complete the validated questionnaire Fatigue Symptom Inventory (FSI)
Day 15 of each 4-week treatment cycle.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Midwestern Regional Medical Center

Investigators

  • Principal Investigator: Dennis Citrin, MD, PhD, Midwestern Regional Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2017

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

July 27, 2015

First Submitted That Met QC Criteria

August 7, 2015

First Posted (Estimate)

August 13, 2015

Study Record Updates

Last Update Posted (Actual)

June 27, 2017

Last Update Submitted That Met QC Criteria

June 23, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MZ2015010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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