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

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02521077

Enrollment

Registered

2015-08-13

Start date

2017-05-31

Completion date

2019-03-31

Last updated

2017-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue

Keywords

Ascorbic Acid, Breast Neoplasms, Fatigue

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.

Interventions

DRUGAscorbic Acid

500 g ascorbic acid dissolved in 500 ml sterile water.

OTHERNormal Saline

Saline 0.9%

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Fatigue by self reported fatigue inventory questionnaire	Day 8 of each 4-week treatment cycle.	Patients will complete the validated questionnaire Fatigue Symptom Inventory (FSI)

Secondary

Measure	Time frame	Description
Fatigue ( EORTC QLQ-FA13)	Day 1 of each 4-week treatment cycle.	Patients will complete the validated questionnaire EORTC QLQ-FA13
Fatigue by self reported fatigue inventory questionnaire	Day 1 of each 4-week treatment cycle.	Patients will complete the validated questionnaire Fatigue Symptom Inventory (FSI)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026