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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
  1. Shown are the 16 trials using medium-to-high dose IVC out of a total 23 studies currently recruiting (status February 2021), as retrieved from the clinicaltrials.govdatabase (see also Fig. 3). Entries are ordered primarily by high-to-medium IVC dose, and secondarily by cancer type