Intravenous Ascorbic Acid Supplementation in Neoadjuvant Chemotherapy for Breast Cancer

Academic Emergency County Hospital Sibiu

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Breast Cancer

Treatments: Drug: Ascorbic Acid; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT03175341

6222/22.03.2017

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

30 participants in 2 patient groups

Vitamin C Supplement

Experimental group

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

Treatment:

Drug: Ascorbic Acid

Placebo

Active Comparator group

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.

Treatment:

Drug: Placebos