Trial | NCT03175341  Report issue

Title

Intravenous Ascorbic Acid Supplementation in Neoadjuvant Chemotherapy for Breast Cancer
Phase I/II Randomized Study to Evaluate the Role of Intravenous Ascorbic Acid Supplementation to Conventional Neoadjuvant Chemotherapy in Women With Breast Cancer

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    vitamin c ...

  • Study Participants

    30
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 Started
Oct 01
2018
Anticipated
Primary Completion
Oct 01
2019
Anticipated
Study Completion
Oct 01
2019
Anticipated
Last Update
Jun 27
2018

Drug 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.

  • Other names: Vitamin C, Chemotherapy

Drug Placebos

100 ml normal saline 0.9%

  • Other names: Normal Saline, Saline 0.9%

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

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.

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)
No Results Posted