Table 3 16 ongoing clincal studies using medium-to-high dose IVC as anti-cancer therapy
From: High-dose intravenous vitamin C, a promising multi-targeting agent in the treatment of cancer
Cancer type(s) | NCT Number | Allocation/ Phase | Interventions | Type of combination therapy | VitC IV dose* | VitC dose and administration schedule | Estimated enrollment | Primary outcome(s) |
|---|---|---|---|---|---|---|---|---|
Colorectal | NCT04516681 [131] | Randomized, Phase 3 | Arm 1: Ascorbic acid + chemotherapy Arm 2: Chemotherapy alone (FOLFOXIRI+/− bevacizumab) | Chemo + Targeted | high | 1.5 g/kg/day, D1–3, every 2 weeks | 400 | Objective Response Rate |
Colorectal, Pancreatic, Lung | NCT03146962 [73] | Single group, Phase 2 | Cohort A: VitC for 2–4 consecutive weeks Cohort 2: VitC up to 6 months Cohort 3: VitC for 1–2 weeks prior to and following Y90 radioembolization of hepatic metastases | RE | high | 1.25 g/kg for 4 days/week | 50 | Pathologic response (cohort A) 3-month disease control rate (DCR) (cohort B) Maximal tolerated dose (cohort C) |
Hepatocellular, Pancreatic, Gastric, Colorectal | NCT04033107 [132] | Single group, Phase 2 | VitC + metformin | Targeted | high | 1.5 g/kg, D1–3, every 2 weeks | 30 | Progression-free survival |
Lung | NCT02420314 [133] | Single group, Phase 2 | Ascorbic acid + paclitaxel + carboplatin | Chemo | high | 75 g, two times/week | 57 | Tumor response |
Lung | NCT02905591 [134] | Single group, Phase 2 | Ascorbate + chemoRT (radiation therapy + paclitaxel + carboplatin) | Chemo-RT | high | 75 g, 3 times/week | 46 | Progression rate |
Lymphoma | NCT03602235 [135] | Single group, Phase 1 | VitC + melphalan | Chemo | high | 50 g, 75 g and 100 g (3 + 3 cohort method) | 9 | Number of treatment related adverse events |
Lymphoma | NCT03418038 [136] | Randomized, Phase 2 | Arm 1: Ascorbic acid + combination chemotherapy Arm 2: Placebo + combination chemotherapy (rituximab + ifosfamide + carboplatin + etoposide D1–3; rituximab + cisplatin + cytarabine + dexamethasone if MR or SD after 2 courses) Arm 3: Ascorbic acid + combination chemotherapy (ifosfamide + carboplatin + etoposide or cisplatin + cytarabine + dexamethasone or gemcitabine + dexamethasone + cisplatin or gemcitabine + oxaliplatin or oxaliplatin + cytarabine + dexamethasone) | Chemo + Targeted + Corticosteroid | high | High dose (n.s.) on D1, 3, 5, 8, 10, 12, 15, 17 and 19, combination chemotherapy on D1–3; treatment repeats every 21 days for up to 4 courses | 151 | Overall response rate |
Pancreatic | NCT02905578 [137] | Randomized, Phase 2 | Arm 1: Ascorbate + chemotherapy Arm 2: Chemotherapy alone (gemcitabine + nab-paclitaxel) | Chemo | high | 75 g, three times/weekly for 4 weeks | 65 | Overall survival |
Pancreatic | NCT04150042 [138] | Single group, Phase 1 | VitC + chemotherapy/stem cell treatment (melphalan + carmustine + vitamin B12B + ethanol) | Chemo + Dietary suppl. | high | Dose-escalation beginning with 3 g/m^2 and escalating to a maximum of 8 g/m^2 | 10 | Rate of mucositis, rate of engraftment of Neutrophils + adverse events, among others |
Pancreatic | NCT03410030 [139] | Single group, Phase 1/2 | Ascorbic acid + nab-paclitaxel + cisplatin + gemcitabine | Chemo | high | ≥ 20 mM plasma concentration | 36 | Phase IB: recommended phase II dose (to reach ≥20 mM) Phase II: disease control rate |
Prostate | NCT02516670 [140] | Randomized, Phase 2 | Arm 1: Ascorbate + Docetaxel Arm 2: Placebo + Docetaxel | Chemo | high | 1 g/kg, 3 times/ week | 69 | Occurrence of PSA decline of > = 50% + adverse events |
Renal Cell | NCT03334409 [141] | Randomized, Phase 2 | Arm 1: Ascorbic acid + tyrosine kinase inhibitor Arm 2: Tyrosine kinase inhibitor alone (Pazopanib) | Targeted | high | 1 g/kg 3 times/week | 91 | Treatment failure-free rate |
Sarcoma | NCT04634227 [142] | Single group, Early phase 1 | Ascorbate + gemcitabine | Chemo | high | 75 g dose on D1–2, until target serum concentration between 20 and 30 mM (otherwise maximum dose of 125 g) | 20 | Progression-free survival |
Sarcoma | NCT03508726 [143] | Single group, Phase 1/2 | Ascorbate + radiation therapy | RT | high | 75 g, three times/week | 25 | Incidence of dose limiting toxicities (DLTs) + tumor response |
Bladder | NCT04046094 [74] | Single group, Phase 1/2 | Ascorbic acid | – | medium | 25 g, 2 times/week for 4 weeks | 21 | Post treatment pathological staging |
Lung | NCT03799094 [144] | Randomized, Phase 1/2 | Arm 1: VitC + tyrosine kinase inhibitor Arm 2: Tyrosine kinase inhibitor alone (osimertinib, erlotinib or gefitinib) | Targeted | medium | 30 g once/week | 150 | Progression-free survival |