Intravenous Ascorbic Acid Supplementation in Neoadjuvant Chemotherapy for Breast Cancer

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03175341
• Other study ID #: 6222/22.03.2017
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• 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
• 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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

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