Intravenous Ascorbic Acid Supplementation in Neoadjuvant Chemotherapy for Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-10-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Parallel Assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Single Blind (Participant)

Study Groups

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Vitamin C Supplement

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

Group Type EXPERIMENTAL

Ascorbic Acid

Intervention Type DRUG

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

Placebo

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.

Group Type ACTIVE_COMPARATOR

Placebos

Intervention Type DRUG

100 ml normal saline 0.9%

Interventions

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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.

Intervention Type DRUG

Placebos

100 ml normal saline 0.9%

Intervention Type DRUG

Other Intervention Names

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Vitamin C Chemotherapy Normal Saline Saline 0.9%

Eligibility 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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No