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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03175341
Other study ID # 6222/22.03.2017
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date October 1, 2018
Est. completion date October 1, 2019

Study information

Verified date June 2018
Source Academic Emergency County Hospital Sibiu
Contact Pop, MD
Phone 0040740551854
Email dr.florinpop@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date October 1, 2019
Est. primary completion date October 1, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ascorbic Acid
1,5 g ascorbic acid dissolved in 100 ml sterile water, and 0,75 g ascorbic acid dissolved in 100 ml sterile water.
Placebos
100 ml normal saline 0.9%

Locations

Country Name City State
Romania Academic Emergency County Hospital Sibiu Sibiu

Sponsors (2)

Lead Sponsor Collaborator
Academic Emergency County Hospital Sibiu CHU-UCL Namur (site Mont-Godinne), Belgium

Country where clinical trial is conducted

Romania, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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