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

Fatigue Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02521077
• Other study ID #: MZ2015010
• Status: Withdrawn
• Phase: Phase 2
• First received: July 27, 2015
• Last updated: June 23, 2017
• Start date: May 2017
• Est. completion date: March 2019

Study information

• Verified date: June 2017
• Source: Midwestern Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatigue

Intervention

Drug:
• Ascorbic Acid
500 g ascorbic acid dissolved in 500 ml sterile water.

Other:
• Normal Saline
Saline 0.9%

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Midwestern Regional Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fatigue ( EORTC QLQ-FA13)	Patients will complete the validated questionnaire EORTC QLQ-FA13	Day 1 of each 4-week treatment cycle.
Secondary	Fatigue ( EORTC QLQ-FA13)	Patients will complete the validated questionnaire EORTC QLQ-FA13	Day 8 of each 4-week treatment cycle.
Secondary	Fatigue ( EORTC QLQ-FA13)	Patients will complete the validated questionnaire EORTC QLQ-FA13	Day 15 of each 4-week treatment cycle.
Secondary	Fatigue by self reported fatigue inventory questionnaire	Patients will complete the validated questionnaire Fatigue Symptom Inventory (FSI)	Day 1 of each 4-week treatment cycle.
Secondary	Fatigue by self reported fatigue inventory questionnaire	Patients will complete the validated questionnaire Fatigue Symptom Inventory (FSI)	Day 15 of each 4-week treatment cycle.