Intravenous Ascorbic Acid Supplementation in Neoadjuvant Chemotherapy for Breast Cancer

NCT03175341 | Unknown Phase 1 DMC

• 1 other identifier: 6222/22.03.2017
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer; ascorbic acid; vitamin C; vitamin supplementation; quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Quality of life

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

• Therapeutic efficacy

  Approximately 6 months

• Objective Response Rate

  every 8 weeks, up to 6 months

• Effect of AA supplementation on serum inflammatory cytokine

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

Study Arms (2)

Vitamin C Supplement

EXPERIMENTAL

Ascorbic Acid (AA) with neoadjuvant chemotherapy. Participants received an initial loading dose of 1,5 g Ascorbic Acid (i.v in 100 ml sterile water) on Day 1 followed by 0,75g Ascorbic Acid (i.v in 100 ml sterile water) on Day 2-4 at each chemotherapy cycle and concomitant neoadjuvant chemotherapy regimens administered at the choice of treating physician. Ascorbic Acid is administered intravenously before neoadjuvant therapy in D1

Drug: Ascorbic Acid

Placebo

ACTIVE COMPARATOR

Placebos (normal saline (0.9%) with neoadjuvant chemotherapy. 100 ml normal saline 0.9% (placebo) will be administered (i.v) by the same scheme as Ascorbic Acid on Day 1 and respectively Day 2-4 at each chemotherapy cycle. Concomitant neoadjuvant chemotherapy regimens administered at the choice of treating physician.

Drug: Placebos

Interventions

Ascorbic Acid DRUG

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

Also known as: Vitamin C, Chemotherapy

Vitamin C Supplement

Placebos DRUG

100 ml normal saline 0.9%

Also known as: Normal Saline, Saline 0.9%

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Academic Emergency County Hospital Sibiu: lead
• CHU-UCL Namur (site Mont-Godinne), Belgium: collaborator

Study Sites (1)

Academic Emergency County Hospital Sibiu

Sibiu, 550245, Romania

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ascorbic Acid; Drug Therapy; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Therapeutics; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Florin Grosu, MD,PhD

  Academic Emergency County Hospital Sibiu

  STUDY DIRECTOR

Central Study Contacts

Pop, MD

CONTACT

0040740551854; dr.florinpop@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single Blind (Participant)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Parallel Assignment

Study Record Dates

• First Submitted: April 29, 2017
• First Posted: June 5, 2017
• Study Start: October 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: June 27, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)