TY - JOUR
T1 - Weekly ascorbic acid infusion in castration-resistant prostate cancer patients
T2 - A single-arm phase II trial
AU - Nielsen, Torben K.
AU - Højgaard, Martin
AU - Andersen, Jon T.
AU - Jørgensen, Niklas Rye
AU - Zerahn, Bo
AU - Kristensen, Bent
AU - Henriksen, Trine
AU - Lykkesfeldt, Jens
AU - Mikines, Kári J.
AU - Poulsen, Henrik E.
PY - 2017
Y1 - 2017
N2 - Background: 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. Methods: 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. Results: 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. Conclusions: 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.
AB - Background: 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. Methods: 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. Results: 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. Conclusions: 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.
KW - Ascorbic acid (AA)
KW - Cancer
KW - Complementary medicine
KW - Prostatic neoplasms
KW - Translational medical research
U2 - 10.21037/tau.2017.04.42
DO - 10.21037/tau.2017.04.42
M3 - Journal article
C2 - 28725594
AN - SCOPUS:85021045570
SN - 2223-4683
VL - 6
SP - 517
EP - 528
JO - Translational Andrology and Urology
JF - Translational Andrology and Urology
IS - 3
ER -
