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Manufacturer unwilling to provide information needed for IND application.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Odd Cycle Intravenous Ascorbic Acid | Experimental | 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%). |
|
| Even Cycle Intravenous Ascorbic Acid | Experimental | 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%). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ascorbic Acid | Drug | 500 g ascorbic acid dissolved in 500 ml sterile water. |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Citrin, MD, PhD | Midwestern Regional Medical Center | Principal Investigator |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Normal Saline | Other | Saline 0.9% |
|
| 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. |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |