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Intravenous Ascorbic Acid Supplementation in Neoadjuvant Chemotherapy for Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 1
Locations
Romania
Study Type
Interventional
Intervention
Ascorbic Acid
Placebos
Sponsored by
Academic Emergency County Hospital Sibiu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, ascorbic acid, vitamin C, vitamin supplementation, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Academic Emergency County Hospital Sibiu

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vitamin C Supplement

Placebo

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Therapeutic efficacy
Therapeutic efficacy assessed by Pathological response. Percentage of Participants Achieving Complete Response (CR) According to the Residual Cancer Burden score.
Objective Response Rate
Objective Response Rate using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Guidelines
Effect of AA supplementation on serum inflammatory cytokine
Assessment of laboratory parameters including interleukin (IL)-6 and vascular endothelial growth factor (VEGF).

Full Information

First Posted
April 29, 2017
Last Updated
June 25, 2018
Sponsor
Academic Emergency County Hospital Sibiu
Collaborators
CHU-UCL Namur (site Mont-Godinne), Belgium
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1. Study Identification

Unique Protocol Identification Number
NCT03175341
Brief Title
Intravenous Ascorbic Acid Supplementation in Neoadjuvant Chemotherapy for Breast Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Anticipated)
Primary Completion Date
October 1, 2019 (Anticipated)
Study Completion Date
October 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academic Emergency County Hospital Sibiu
Collaborators
CHU-UCL Namur (site Mont-Godinne), Belgium

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, ascorbic acid, vitamin C, vitamin supplementation, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized Parallel Assignment
Masking
Participant
Masking Description
Single Blind (Participant)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin C Supplement
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ascorbic Acid
Other Intervention Name(s)
Vitamin C, Chemotherapy
Intervention Description
1,5 g ascorbic acid dissolved in 100 ml sterile water, and 0,75 g ascorbic acid dissolved in 100 ml sterile water.
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
Normal Saline, Saline 0.9%
Intervention Description
100 ml normal saline 0.9%
Primary Outcome Measure Information:
Title
Number of Patients With Adverse Events as a Measure of Safety and Tolerability
Description
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
Time Frame
during the six months of neoadjuvant chemotherapy
Secondary Outcome Measure Information:
Title
Quality of life
Description
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
Time Frame
At baseline and each 28 days during the six months of neoadjuvant chemotherapy
Title
Therapeutic efficacy
Description
Therapeutic efficacy assessed by Pathological response. Percentage of Participants Achieving Complete Response (CR) According to the Residual Cancer Burden score.
Time Frame
Approximately 6 months
Title
Objective Response Rate
Description
Objective Response Rate using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Guidelines
Time Frame
every 8 weeks, up to 6 months
Title
Effect of AA supplementation on serum inflammatory cytokine
Description
Assessment of laboratory parameters including interleukin (IL)-6 and vascular endothelial growth factor (VEGF).
Time Frame
At baseline and every 8 weeks during the six months of neoadjuvant chemotherapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pop, MD
Phone
0040740551854
Email
dr.florinpop@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florin Grosu, MD,PhD
Organizational Affiliation
Academic Emergency County Hospital Sibiu
Official's Role
Study Director
Facility Information:
Facility Name
Academic Emergency County Hospital Sibiu
City
Sibiu
ZIP/Postal Code
550245
Country
Romania
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catalin Florin Pop, MD
Email
dr.florinpop@gmail.com
First Name & Middle Initial & Last Name & Degree
Catalin Florin Pop, MD
First Name & Middle Initial & Last Name & Degree
Claudia Maria Stanciu Pop, MD
First Name & Middle Initial & Last Name & Degree
Florin Grosu, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Intravenous Ascorbic Acid Supplementation in Neoadjuvant Chemotherapy for Breast Cancer

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