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| Name | Class |
|---|---|
| CHU-UCL Namur (site Mont-Godinne), Belgium | UNKNOWN |
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Forty years ago clinical studies conducted by Ewan Cameron and Linus Pauling suggested that intravenous (IV) and oral ascorbic acid (AA) may diminish symptoms and could improve survival in terminal cancer patients. Previous phase I and II clinical trials have found that high dose (1.5g/kg ) iv AA is well tolerated in cancer patients. This is a phase I/II, randomized study of parenteral administration of Ascorbic Acid (AA) as a supplement to the conventional neo-adjuvant chemotherapy in women with breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin C Supplement | Experimental | Ascorbic Acid (AA) with neoadjuvant chemotherapy. Participants received an initial loading dose of 1,5 g Ascorbic Acid (i.v in 100 ml sterile water) on Day 1 followed by 0,75g Ascorbic Acid (i.v in 100 ml sterile water) on Day 2-4 at each chemotherapy cycle and concomitant neoadjuvant chemotherapy regimens administered at the choice of treating physician. Ascorbic Acid is administered intravenously before neoadjuvant therapy in D1 |
|
| Placebo | Active Comparator | Placebos (normal saline (0.9%) with neoadjuvant chemotherapy. 100 ml normal saline 0.9% (placebo) will be administered (i.v) by the same scheme as Ascorbic Acid on Day 1 and respectively Day 2-4 at each chemotherapy cycle. Concomitant neoadjuvant chemotherapy regimens administered at the choice of treating physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ascorbic Acid | Drug | 1,5 g ascorbic acid dissolved in 100 ml sterile water, and 0,75 g ascorbic acid dissolved in 100 ml sterile water. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Events as a Measure of Safety and Tolerability | Assessments are made through analysis of reported incidence of treatment-emergent Adverse Events. Toxicities (AEs) in both groups will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 | during the six months of neoadjuvant chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | The symptom checklist and the symptom related measures as defined by European Organization for Research and Treatment of Cancer (Questionnaire C30 and BR23) will be compared between arms using frequency tables | At baseline and each 28 days during the six months of neoadjuvant chemotherapy |
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Inclusion Criteria:
Exclusion Criteria:
Aspirin (exceeding 325 mg/day) Acetaminophen (exceeding 2 g/day) Glutathione Vitamin D (important doses)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pop, MD | Contact | 0040740551854 | dr.florinpop@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Florin Grosu, MD,PhD | Academic Emergency County Hospital Sibiu | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Emergency County Hospital Sibiu | Sibiu | 550245 | Romania |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D004358 | Drug Therapy |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Randomized Parallel Assignment
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Single Blind (Participant)
| Placebos | Drug | 100 ml normal saline 0.9% |
|
|
| Therapeutic efficacy |
Therapeutic efficacy assessed by Pathological response. Percentage of Participants Achieving Complete Response (CR) According to the Residual Cancer Burden score. |
| Approximately 6 months |
| Objective Response Rate | Objective Response Rate using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Guidelines | every 8 weeks, up to 6 months |
| Effect of AA supplementation on serum inflammatory cytokine | Assessment of laboratory parameters including interleukin (IL)-6 and vascular endothelial growth factor (VEGF). | At baseline and every 8 weeks during the six months of neoadjuvant chemotherapy |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
| D013812 | Therapeutics |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |