Clinical trial · Interventional

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

NCT02521077CI-TRIAL-00028292withdrawnPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Manufacturer unwilling to provide information needed for IND application.

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Fatigue	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Ascorbic Acid	Drug	—	UNRESOLVED
Normal Saline	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Odd Cycle Intravenous Ascorbic Acid
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%).
interventionNames
1. Drug: Ascorbic Acid
2. Other: Normal Saline
type
EXPERIMENTAL
label
Even Cycle Intravenous Ascorbic Acid
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%).
interventionNames
1. Drug: Ascorbic Acid
2. Other: Normal Saline

Primary outcomes (1)

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.