Format

Send to

Choose Destination
Eur J Pharm Sci. 2017 Nov 15;109:412-418. doi: 10.1016/j.ejps.2017.08.011. Epub 2017 Aug 25.

The safety and pharmacokinetics of high dose intravenous ascorbic acid synergy with modulated electrohyperthermia in Chinese patients with stage III-IV non-small cell lung cancer.

Author information

1
Cancer Center, Clifford Hospital, Guangzhou University of Chinese Medicine, No.3. Hongfu Road, Panyu District, Guangzhou 511495, PR China; Basic Medicine, Guangzhou University of Chinese Medicine, No.232 Waihuan Dong Road, Guangzhou Higher Education Mega Center Town, Panyu, Guangzhou 510006, PR China. Electronic address: oujunwen66@clifford-hospital.org.cn.
2
Cancer Center, Clifford Hospital, Guangzhou University of Chinese Medicine, No.3. Hongfu Road, Panyu District, Guangzhou 511495, PR China.
3
Hyperthermia Center, Clifford Hospital, Guangzhou University of Chinese Medicine, No.3 Hongfu Road, Panyu District, Guangzhou 511495, PR China.

Abstract

Ascorbic acid (AA) infusion and modulated electrohyperthermia (mEHT) are widely used by integrative cancer practitioners for many years. However, there are no safety and pharmacokinetics data in Chinese cancer patients. We carried out a clinical trial to evaluate the safety and pharmacokinetics of those methods in patients with stage III-IV non-small cell lung cancer (NSCLC). Blood ascorbic acid in the fasting state was obtained from 35 NSCLC patients; selecting from them 15 patients with stage III-IV entered the phase I study. They were randomized allocated into 3 groups, and received doses 1.0, 1.2, 1.5g/kg AA infusions. Participants in the first group received intravenous AA (IVAA) when mEHT was finished, in the second group IVAA was administered simultaneously with mEHT and in the third group IVAA was applied first, and followed with mEHT. Pharmacokinetic profiles were obtained when they received solely IVAA and when IVAA in combination with mEHT. The process was applied 3 times a week (every other day, weekend days off) for 4weeks. We found that fasting plasma AA levels were significantly correlated with stage of the disease. Peak concentration of AA was significantly higher in the simultaneous treatments than in other combinations with mEHT or in solely IVAA-managed groups. IVAA synergy with simultaneous mEHT is safe and the concomitant application significantly increases the plasma AA level for NSCLC patients.

KEYWORDS:

Ascorbic acid; Pharmacokinetics; Phase I clinical trial; Stage III-IV NSCLC; mEHT

PMID:
28847527
DOI:
10.1016/j.ejps.2017.08.011
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center