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

Primary Purpose

Fatigue

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ascorbic Acid
Normal Saline
Sponsored by
Midwestern Regional Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fatigue focused on measuring Ascorbic Acid, Breast Neoplasms, Fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Odd Cycle Intravenous Ascorbic Acid

    Even Cycle Intravenous Ascorbic Acid

    Arm 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%).

    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%).

    Outcomes

    Primary Outcome Measures

    Fatigue by self reported fatigue inventory questionnaire
    Patients will complete the validated questionnaire Fatigue Symptom Inventory (FSI)

    Secondary Outcome Measures

    Fatigue ( EORTC QLQ-FA13)
    Patients will complete the validated questionnaire EORTC QLQ-FA13
    Fatigue ( EORTC QLQ-FA13)
    Patients will complete the validated questionnaire EORTC QLQ-FA13
    Fatigue ( EORTC QLQ-FA13)
    Patients will complete the validated questionnaire EORTC QLQ-FA13
    Fatigue by self reported fatigue inventory questionnaire
    Patients will complete the validated questionnaire Fatigue Symptom Inventory (FSI)
    Fatigue by self reported fatigue inventory questionnaire
    Patients will complete the validated questionnaire Fatigue Symptom Inventory (FSI)

    Full Information

    First Posted
    July 27, 2015
    Last Updated
    June 23, 2017
    Sponsor
    Midwestern Regional Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02521077
    Brief Title
    Intravenous Ascorbic Acid in Women Receiving Adjuvant or Neo-Adjuvant Chemotherapy for Early Stage Breast Cancer
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Manufacturer unwilling to provide information needed for IND application.
    Study Start Date
    May 2017 (Anticipated)
    Primary Completion Date
    March 2019 (Anticipated)
    Study Completion Date
    March 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Midwestern Regional Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fatigue
    Keywords
    Ascorbic Acid, Breast Neoplasms, Fatigue

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Odd Cycle Intravenous Ascorbic Acid
    Arm Type
    Experimental
    Arm 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 Title
    Even Cycle Intravenous Ascorbic Acid
    Arm Type
    Experimental
    Arm 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%).
    Intervention Type
    Drug
    Intervention Name(s)
    Ascorbic Acid
    Other Intervention Name(s)
    Vitamin C
    Intervention Description
    500 g ascorbic acid dissolved in 500 ml sterile water.
    Intervention Type
    Other
    Intervention Name(s)
    Normal Saline
    Intervention Description
    Saline 0.9%
    Primary Outcome Measure Information:
    Title
    Fatigue by self reported fatigue inventory questionnaire
    Description
    Patients will complete the validated questionnaire Fatigue Symptom Inventory (FSI)
    Time Frame
    Day 8 of each 4-week treatment cycle.
    Secondary Outcome Measure Information:
    Title
    Fatigue ( EORTC QLQ-FA13)
    Description
    Patients will complete the validated questionnaire EORTC QLQ-FA13
    Time Frame
    Day 1 of each 4-week treatment cycle.
    Title
    Fatigue ( EORTC QLQ-FA13)
    Description
    Patients will complete the validated questionnaire EORTC QLQ-FA13
    Time Frame
    Day 8 of each 4-week treatment cycle.
    Title
    Fatigue ( EORTC QLQ-FA13)
    Description
    Patients will complete the validated questionnaire EORTC QLQ-FA13
    Time Frame
    Day 15 of each 4-week treatment cycle.
    Title
    Fatigue by self reported fatigue inventory questionnaire
    Description
    Patients will complete the validated questionnaire Fatigue Symptom Inventory (FSI)
    Time Frame
    Day 1 of each 4-week treatment cycle.
    Title
    Fatigue by self reported fatigue inventory questionnaire
    Description
    Patients will complete the validated questionnaire Fatigue Symptom Inventory (FSI)
    Time Frame
    Day 15 of each 4-week treatment cycle.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dennis Citrin, MD, PhD
    Organizational Affiliation
    Midwestern Regional Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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