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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Fatigue

Intervention / Treatment
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* Drug: Ascorbic Acid
* Other: Normal Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Odd Cycle Intravenous Ascorbic Acid<br>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<br>* 500 g ascorbic acid dissolved in 500 ml sterile water.<br>* Other names: Vitamin C;Other: Normal Saline<br>* Saline 0.9%<br>|
| Experimental: Even Cycle Intravenous Ascorbic Acid<br>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<br>* 500 g ascorbic acid dissolved in 500 ml sterile water.<br>* Other names: Vitamin C;Other: Normal Saline<br>* Saline 0.9%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue ( EORTC QLQ-FA13) | Patients will complete the validated questionnaire EORTC QLQ-FA13 | Day 1 of each 4-week treatment cycle. | 
| Fatigue ( EORTC QLQ-FA13) | Patients will complete the validated questionnaire EORTC QLQ-FA13 | Day 8 of each 4-week treatment cycle. | 
| Fatigue ( EORTC QLQ-FA13) | Patients will complete the validated questionnaire EORTC QLQ-FA13 | Day 15 of each 4-week treatment cycle. | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ascorbic Acid, Breast Neoplasms, Fatigue