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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03175341 |
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Date of registration:
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29/04/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Intravenous Ascorbic Acid Supplementation in Neoadjuvant Chemotherapy for Breast Cancer
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Scientific title:
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Phase I/II Randomized Study to Evaluate the Role of Intravenous Ascorbic Acid Supplementation to Conventional Neoadjuvant Chemotherapy in Women With Breast Cancer |
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Date of first enrolment:
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October 1, 2018 |
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Target sample size:
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30 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT03175341 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Romania
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Contacts
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Name:
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Florin Grosu, MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Academic Emergency County Hospital Sibiu |
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Name:
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Catalin Florin Pop, MD |
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Address:
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Telephone:
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Email:
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dr.florinpop@gmail.com |
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Affiliation:
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Name:
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Pop, MD |
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Address:
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Telephone:
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0040740551854 |
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Email:
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dr.florinpop@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Drug: Ascorbic Acid
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Drug: Placebos
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Primary Outcome(s)
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Number of Patients With Adverse Events as a Measure of Safety and Tolerability
[Time Frame: during the six months of neoadjuvant chemotherapy]
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Secondary Outcome(s)
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Quality of life
[Time Frame: At baseline and each 28 days during the six months of neoadjuvant chemotherapy]
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Effect of AA supplementation on serum inflammatory cytokine
[Time Frame: At baseline and every 8 weeks during the six months of neoadjuvant chemotherapy]
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Objective Response Rate
[Time Frame: every 8 weeks, up to 6 months]
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Therapeutic efficacy
[Time Frame: Approximately 6 months]
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Secondary ID(s)
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6222/22.03.2017
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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