Weekly ascorbic acid infusion in castration-resistant prostate cancer patients: a single-arm phase II trial.
Weekly ascorbic acid infusion in castration-resistant prostate cancer patients: a single-arm phase II trial.
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DOI：
10.21037/tau.2017.04.42
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发表时间：
2017-06
影响因子：
2
通讯作者：
Poulsen HE
中科院分区：
文献类型：
--
作者：
Nielsen TK;Højgaard M;Andersen JT;Jørgensen NR;Zerahn B;Kristensen B;Henriksen T;Lykkesfeldt J;Mikines KJ;Poulsen HE
Ascorbic acid (AA) has in vivo cytotoxic properties at concentrations that can only be achieved through intravenous (IV) administration in humans. Treatment with intravenous AA is widely and increasingly used in complementary medicine despite a lack of clinical evidence for the efficacy of this treatment. This non-comparative, single-center, phase II trial included patients with chemotherapy-naïve, metastatic castration-resistant prostate cancer (mCRPC) from an outpatient clinic to evaluate the efficacy and safety of IV AA therapy. Patients received weekly infusions of AA (week 1, 5 g; week 2, 30 g; and weeks 3–12, 60 g) followed by efficacy evaluation at 12 weeks. The primary endpoint for efficacy was a 50% reduction in the prostate-specific antigen (PSA) level. The secondary endpoints included changes in health-related quality of life (HRQoL), biomarkers of bone metabolism, inflammation and bone scans. Clinicaltrials.gov identifier: NCT01080352. Twenty-three patients were enrolled in this study, and 20 completed the efficacy evaluation at 12 weeks. The mean baseline PSA level was 43 µg/L. No patient achieved a 50% PSA reduction; instead, a median increase in PSA of 17 µg/L was recorded at week 12. Among the secondary endpoints, no signs of disease remission were observed. In total, 53 adverse events (AEs) were recorded. Eleven were graded as “serious”. Three AEs were directly related to AA, and all of which were related to fluid load. Infusion with 60 g of AA did not result in disease remission. This study does not support the use of intravenous AA outside clinical trials.
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影响因子：
158.5
作者：
Kantoff, Philip W.;Higano, Celestia S.;Young, J.
通讯作者：
Young, J.
影响因子：
158.5
作者：
CREAGAN, ET;MOERTEL, CG;FRYTAK, S
通讯作者：
FRYTAK, S
影响因子：
37.8
作者：
Lee, AYY;Levine, MN
通讯作者：
Levine, MN
DOI：
10.1073/pnas.0804226105
发表时间：
2008-08-12
影响因子：
11.1
作者：
Chen, Qi;Espey, Michael Graham;Levine, Mark
通讯作者：
Levine, Mark
影响因子：
7.4
作者：
Kuiper, Caroline;Vissers, Margreet C. M.;Hicks, Kevin O.
通讯作者：
Hicks, Kevin O.