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Intravenous Ascorbic Acid Supplementation in Neoadjuvant Chemotherapy for Breast Cancer

NCT03175341 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-06-27

No results posted yet for this study

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

Interventions

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.

DRUG

Placebos

100 ml normal saline 0.9%

Sponsors & Collaborators

  • CHU-UCL Namur (site Mont-Godinne), Belgium

    collaborator UNKNOWN

  • Academic Emergency County Hospital Sibiu

    lead OTHER

Principal Investigators

  • Florin Grosu, MD,PhD · Academic Emergency County Hospital Sibiu

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2019-10-01
Completion
2019-10-01

Countries

  • Romania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03175341 on ClinicalTrials.gov