Clinical trial NCT03175341: Intravenous Ascorbic Acid Supplementation in Neoadjuvant Chemotherapy for Breast Cancer
Official title: Phase I/II Randomized Study to Evaluate the Role of Intravenous Ascorbic Acid Supplementation to Conventional Neoadjuvant Chemotherapy in Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Keywords: breast cancer
ascorbic acid
vitamin C
vitamin supplementation
quality of life
Lead sponsor: Academic Emergency County Hospital Sibiu
Sponsor class: OTHER
Collaborators: name: CHU-UCL Namur (site Mont-Godinne), Belgium
First posted: 2017-06-05
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Parallel Assignment
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of Patients With Adverse Events as a Measure of Safety and Tolerability
timeFrame: during the six months of neoadjuvant chemotherapy
Secondary outcomes:
measure: Quality of life
timeFrame: At baseline and each 28 days during the six months of neoadjuvant chemotherapy
measure: Therapeutic efficacy
timeFrame: Approximately 6 months
measure: Objective Response Rate
timeFrame: every 8 weeks, up to 6 months
measure: Effect of AA supplementation on serum inflammatory cytokine
timeFrame: At baseline and every 8 weeks during the six months of neoadjuvant chemotherapy
Other outcomes:
Locations:
city: Sibiu
country: Romania
facility: Academic Emergency County Hospital Sibiu
Study officials:
affiliation: Academic Emergency County Hospital Sibiu
name: Florin Grosu, MD,PhD
role: STUDY_DIRECTOR
References: