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

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

Sponsors

Lead sponsor: Midwestern Regional Medical Center

Source 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.

Overall Status Withdrawn
Start Date May 2017
Completion Date March 2019
Primary Completion Date March 2019
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Fatigue by self reported fatigue inventory questionnaire Day 8 of each 4-week treatment cycle.
Secondary Outcome
Measure Time Frame
Fatigue ( EORTC QLQ-FA13) Day 1 of each 4-week treatment cycle.
Fatigue ( EORTC QLQ-FA13) Day 8 of each 4-week treatment cycle.
Fatigue ( EORTC QLQ-FA13) Day 15 of each 4-week treatment cycle.
Fatigue by self reported fatigue inventory questionnaire Day 1 of each 4-week treatment cycle.
Fatigue by self reported fatigue inventory questionnaire Day 15 of each 4-week treatment cycle.
Condition
Intervention

Intervention type: Drug

Intervention name: Ascorbic Acid

Description: 500 g ascorbic acid dissolved in 500 ml sterile water.

Other name: Vitamin C

Intervention type: Other

Intervention name: Normal Saline

Description: Saline 0.9%

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

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Dennis Citrin, MD, PhD Principal Investigator Midwestern Regional Medical Center
Verification Date

June 2017

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Midwestern Regional Medical Center

Investigator full name: Dennis Citrin, MD

Investigator title: Medical Oncologist

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Odd Cycle Intravenous Ascorbic Acid

Arm group type: Experimental

Description: 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%).

Arm group label: Even Cycle Intravenous Ascorbic Acid

Arm group type: Experimental

Description: 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%).

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov