NCT02521077

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2017

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
1.7 years until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

June 27, 2017

Status Verified

June 1, 2017

Enrollment Period

1.8 years

First QC Date

July 27, 2015

Last Update Submit

June 23, 2017

Conditions

Fatigue

Keywords

Ascorbic AcidBreast NeoplasmsFatigue

Outcome Measures

Primary Outcomes (1)

  • Fatigue by self reported fatigue inventory questionnaire

    Patients will complete the validated questionnaire Fatigue Symptom Inventory (FSI)

    Day 8 of each 4-week treatment cycle.

Secondary Outcomes (5)

  • 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.

Study Arms (2)

Odd Cycle Intravenous Ascorbic Acid

EXPERIMENTAL

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 AcidOther: Normal Saline

Even Cycle Intravenous Ascorbic Acid

EXPERIMENTAL

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 AcidOther: Normal Saline

Interventions

Ascorbic AcidDRUG

500 g ascorbic acid dissolved in 500 ml sterile water.

Also known as: Vitamin C
Even Cycle Intravenous Ascorbic AcidOdd Cycle Intravenous Ascorbic Acid
Normal SalineOTHER

Saline 0.9%

Even Cycle Intravenous Ascorbic AcidOdd Cycle Intravenous Ascorbic Acid

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

FatigueBreast Neoplasms

Interventions

Ascorbic AcidSaline Solution

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydratesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Dennis Citrin, MD, PhD

    Midwestern Regional Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Oncologist

Study Record Dates

First Submitted

July 27, 2015

First Posted

August 13, 2015

Study Start

May 1, 2017

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

June 27, 2017

Record last verified: 2017-06