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

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ClinicalTrials.gov Identifier: NCT02521077
Recruitment Status : Withdrawn (Manufacturer unwilling to provide information needed for IND application.)
First Posted : August 13, 2015
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Dennis Citrin, MD, 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.

Condition or disease Intervention/treatment Phase
Fatigue Drug: Ascorbic Acid Other: Normal Saline Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : May 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Vitamin C

Other: Normal Saline
Saline 0.9%




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Fatigue ( EORTC QLQ-FA13) [ Time Frame: Day 1 of each 4-week treatment cycle. ]
    Patients will complete the validated questionnaire EORTC QLQ-FA13

  2. Fatigue ( EORTC QLQ-FA13) [ Time Frame: Day 8 of each 4-week treatment cycle. ]
    Patients will complete the validated questionnaire EORTC QLQ-FA13

  3. Fatigue ( EORTC QLQ-FA13) [ Time Frame: Day 15 of each 4-week treatment cycle. ]
    Patients will complete the validated questionnaire EORTC QLQ-FA13

  4. 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)

  5. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02521077


Sponsors and Collaborators
Midwestern Regional Medical Center
Investigators
Principal Investigator: Dennis Citrin, MD, PhD Midwestern Regional Medical Center

Responsible Party: Dennis Citrin, MD, Medical Oncologist, Midwestern Regional Medical Center
ClinicalTrials.gov Identifier: NCT02521077     History of Changes
Other Study ID Numbers: MZ2015010
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dennis Citrin, MD, Midwestern Regional Medical Center:
Ascorbic Acid
Breast Neoplasms
Fatigue

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms
Ascorbic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances