Breast CancerPhase 1/2NCT03175341
Intravenous Ascorbic Acid Supplementation in Neoadjuvant Chemotherapy for Breast Cancer
A Phase 1/2 study testing Ascorbic Acid in people with Breast Cancer, run by Academic Emergency County Hospital Sibiu at 1 site in Romania.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Ascorbic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteRomania
- Study dates
- 1 Oct 2018to 1 Oct 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Romania1 site
Academic Emergency County Hospital Sibiu
Sibiu, 550245
Catalin Florin Pop, MD, dr.florinpop@gmail.com
Catalin Florin Pop, MD
About this study
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
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
- Being tested
- Ascorbic Acid, Placebos
- Keywords
- breast cancer, ascorbic acid, vitamin C, vitamin supplementation, quality of life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic AcidDrug
Also called Vitamin C, Chemotherapy
1,5 g ascorbic acid dissolved in 100 ml sterile water, and 0,75 g ascorbic acid dissolved in 100 ml sterile water.
PlacebosDrug
Also called Normal Saline, Saline 0.9%
100 ml normal saline 0.9%
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during the six months of neoadjuvant chemotherapy
Secondary outcomes (4)
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
Measured: At baseline and each 28 days during the six months of neoadjuvant chemotherapy
Therapeutic efficacy
Therapeutic efficacy assessed by Pathological response. Percentage of Participants Achieving Complete Response (CR) According to the Residual Cancer Burden score.
Measured: Approximately 6 months
Objective Response Rate
Objective Response Rate using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Guidelines
Measured: every 8 weeks, up to 6 months
Effect of AA supplementation on serum inflammatory cytokine
Assessment of laboratory parameters including interleukin (IL)-6 and vascular endothelial growth factor (VEGF).
Measured: At baseline and every 8 weeks during the six months of neoadjuvant chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start1 Oct 2018 (estimated)
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academic Emergency County Hospital Sibiu
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire UCLouvain Namur
- Responsible party
- Principal investigator, Pop Catalin Florin, MD, Academic Emergency County Hospital Sibiu
- Investigators
- Florin Grosu, MD,PhD, Study director, Academic Emergency County Hospital Sibiu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175341
- Sponsor's protocol ID
- 6222/22.03.2017
- Status last verified
- Jun 2018
- First submitted
- 29 Apr 2017
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03175341
- Acronym / sponsor ID
- 6222/22.03.2017
- Conditions
- Breast Cancer
- Keywords
- breast cancer, ascorbic acid, vitamin C, vitamin supplementation, quality of life
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Academic Emergency County Hospital SibiuUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire UCLouvain Namur
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Vitamin C Supplement | Experimental | Drug: Ascorbic AcidAscorbic 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 |
| Placebo | Active comparator | Drug: PlacebosPlacebos (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascorbic AcidAlso: Vitamin C, Chemotherapy1,5 g ascorbic acid dissolved in 100 ml sterile water, and 0,75 g ascorbic acid dissolved in 100 ml sterile water. | Drug | Vitamin C Supplement |
| PlacebosAlso: Normal Saline, Saline 0.9%100 ml normal saline 0.9% | Drug | Placebo |
Primary outcome
Number of Patients With Adverse Events as a Measure of Safety and Tolerability
Time frame: during the six months of neoadjuvant chemotherapy
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
4 secondary outcomes
Quality of life
Time frame: At baseline and each 28 days during the six months of neoadjuvant chemotherapy
Therapeutic efficacy
Time frame: Approximately 6 months
Objective Response Rate
Time frame: every 8 weeks, up to 6 months
Effect of AA supplementation on serum inflammatory cytokine
Time frame: At baseline and every 8 weeks during the six months of neoadjuvant chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florin Grosu, MD,PhD study director
Academic Emergency County Hospital Sibiu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ascorbic Acid in people with Breast Cancer, run by Academic Emergency County Hospital Sibiu at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pop, MD (0040740551854, dr.florinpop@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Adverse Events as a Measure of Safety and Tolerability (time frame: during the six months of neoadjuvant chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2018.