Intravenous Ascorbic Acid Supplementation in Neoadjuvant Chemotherapy for Breast Cancer

Academic Emergency County Hospital Sibiu30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Breast Cancer

Interventions

Ascorbic AcidDRUG

1,5 g ascorbic acid dissolved in 100 ml sterile water, and 0,75 g ascorbic acid dissolved in 100 ml sterile water.

PlacebosDRUG

100 ml normal saline 0.9%

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Academic Emergency County Hospital Sibiu

Sibiu, Romania

Outcomes

Primary Outcomes

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

Time frame: during the six months of neoadjuvant chemotherapy

Secondary Outcomes

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

Time frame: At baseline and each 28 days during the six months of neoadjuvant chemotherapy

Therapeutic efficacy

Therapeutic efficacy assessed by Pathological response. Percentage of Participants Achieving Complete Response (CR) According to the Residual Cancer Burden score.

Time frame: Approximately 6 months

Objective Response Rate

Objective Response Rate using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Guidelines

Time frame: 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).

Time frame: At baseline and every 8 weeks during the six months of neoadjuvant chemotherapy

Central Contacts

Pop, MD

CONTACT

0040740551854 dr.florinpop@gmail.com

Data from ClinicalTrials.gov

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