Breast Cancer
Conditions
Keywords
breast cancer, ascorbic acid, vitamin C, vitamin supplementation, quality of life
Brief summary
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.
Interventions
DRUGAscorbic Acid
1,5 g ascorbic acid dissolved in 100 ml sterile water, and 0,75 g ascorbic acid dissolved in 100 ml sterile water.
DRUGPlacebos
100 ml normal saline 0.9%
Sponsors
CHU-UCL Namur (site Mont-Godinne), Belgium
Academic Emergency County Hospital Sibiu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single Blind (Participant)
Intervention model description
Randomized Parallel Assignment
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance status score ≤2; * Diagnosed high-risk breast cancers (tumours ≥ 2cm and/or locally advanced breast tumors) and scheduled to receive neoadjuvant chemotherapy; * Agree to avoid any additional supplemental ascorbic acid throughout the study; * Normal glucose-6- phosphate dehydrogenase (G6PD) activity; * Normal renal function (serum creatinine ≤ 1.2 mg/dl) and normal liver function; * No evidence of urolithiasis; * No evidence of chronic hemodialysis, iron overload (serum ferritin 500 ng/ml); * Not pregnant or lactating women
Exclusion criteria
* Important psychosomatic diseases or known gastrointestinal disorders (ulcer, gastritis, colitis, ileitis); * Current smoking and/or alcohol consumption ≥ 3UI per day; * Current use of the following drugs: Aspirin (exceeding 325 mg/day) Acetaminophen (exceeding 2 g/day) Glutathione Vitamin D (important doses)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Adverse Events as a Measure of Safety and Tolerability | during the six months of neoadjuvant chemotherapy | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | At baseline and each 28 days during the six months of neoadjuvant chemotherapy | 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 |
| Therapeutic efficacy | Approximately 6 months | Therapeutic efficacy assessed by Pathological response. Percentage of Participants Achieving Complete Response (CR) According to the Residual Cancer Burden score. |
| Objective Response Rate | every 8 weeks, up to 6 months | Objective Response Rate using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Guidelines |
| Effect of AA supplementation on serum inflammatory cytokine | At baseline and every 8 weeks during the six months of neoadjuvant chemotherapy | Assessment of laboratory parameters including interleukin (IL)-6 and vascular endothelial growth factor (VEGF). |
Countries
Romania
Contacts
Primary ContactPop, MD
Outcome results
None listed