ClinicalTrials.gg
Sign In
WithdrawnNCT02521077Updated Jun 27, 2017

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

A Phase 2 interventional study of Ascorbic Acid and Normal Saline in Fatigue, sponsored by Midwestern Regional Medical Center. Withdrawn. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-27.

Sponsored by Midwestern Regional Medical Center · Phase 2, Interventional, and Supportive care

Why this study was withdrawn
Manufacturer unwilling to provide information needed for IND application.
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Fatigue

Keywords

  • Ascorbic Acid
  • Breast Neoplasms
  • Fatigue
03

In context

Fatigue

1,912 studies on the registry are indexed under Fatigue; 381 are open to participants now.

Browse Fatigue studies →

Lead sponsor

Midwestern Regional Medical Center is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
0 participants (actual)

Study arms

  • 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 · Other: Normal Saline

  • 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 · Other: Normal Saline

Interventions

  • DrugAscorbic Acid

    500 g ascorbic acid dissolved in 500 ml sterile water.

    Also known as: Vitamin C

  • OtherNormal Saline

    Saline 0.9%

06

What researchers measure

Primary outcomes

  1. Fatigue by self reported fatigue inventory questionnaire

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

    Time frame: Day 8 of each 4-week treatment cycle.

Secondary outcomes

  1. Fatigue ( EORTC QLQ-FA13)

    Patients will complete the validated questionnaire EORTC QLQ-FA13

    Time frame: Day 1 of each 4-week treatment cycle.

  2. Fatigue ( EORTC QLQ-FA13)

    Patients will complete the validated questionnaire EORTC QLQ-FA13

    Time frame: Day 8 of each 4-week treatment cycle.

  3. Fatigue ( EORTC QLQ-FA13)

    Patients will complete the validated questionnaire EORTC QLQ-FA13

    Time frame: Day 15 of each 4-week treatment cycle.

  4. Fatigue by self reported fatigue inventory questionnaire

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

    Time frame: Day 1 of each 4-week treatment cycle.

  5. Fatigue by self reported fatigue inventory questionnaire

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

    Time frame: Day 15 of each 4-week treatment cycle.

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2017; primary completion for Mar 2019, 22 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 27, 2015
First posted
Aug 13, 2015
StartEst.
May 2017
Primary completionEst.
Mar 2019
CompletionEst.
Mar 2019
Last update
Jun 27, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02521077
Lead sponsor
Midwestern Regional Medical Center
Responsible party
Dennis Citrin, MD (Medical Oncologist, Midwestern Regional Medical Center) — Principal investigator
First posted
Aug 13, 2015
Start date
May 2017 (estimated)
Primary completion
Mar 2019 (estimated)
Completion
Mar 2019 (estimated)
Last update
Jun 27, 2017

Study contacts

Dennis Citrin, MD, PhD
principal investigator · Midwestern Regional Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Ascorbic Acid

Other studies in this condition

Fatigue →

Other studies from this sponsor

Midwestern Regional Medical Center

Start the discussion