Back to Search
Start Over
Oltipraz chemoprevention trial in Qidong, People's Republic of China: study design and clinical outcomes.
- Source :
-
Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology [Cancer Epidemiol Biomarkers Prev] 1997 Apr; Vol. 6 (4), pp. 257-65. - Publication Year :
- 1997
-
Abstract
- In 1995, 234 adults from Qidong, Jiangsu Province, People's Republic of China, where hepatocellular carcinoma is the leading cause of cancer deaths and exposure to dietary aflatoxins is widespread, were enrolled and followed in a Phase II chemoprevention trial. The goals of the study were to define a dose and schedule of oltipraz for reducing levels of validated aflatoxin biomarkers and to characterize dose-limiting toxicities. Healthy eligible individuals, including those infected with hepatitis B virus, were randomized to receive either 125 mg of oltipraz daily, 500 mg of oltipraz weekly, or placebo. Blood and urine specimens were collected to monitor toxicities and evaluate biomarkers over the 8-week intervention period and subsequent 8-week follow-up period. Unique trial aspects included a synchronous follow-up schedule, daily observed administration of all medications, timely international data transference, and use of biomarkers as outcomes. One hundred thirty-two participants took their medications without interruptions, approximately 77% contributed all nine urine samples, and 78% contributed all seven blood samples. Fifty-one participants (21.8%) reported clinical adverse events. An extremity syndrome, developing soon after the start of treatment, was the only event that occurred more frequently (P = 0.002) among the active groups (18.4 and 14.1% of the daily 125 and weekly 500 mg arms, respectively) compared with placebo (2.5%). The oltipraz arms did not differ in symptom type or severity, and there were no indications of exacerbated drug intolerance among the few participants infected with hepatitis B virus. The good compliance with an intense follow-up schedule shows that chemoprevention trials with biomarker end points may be conducted in such populations.
- Subjects :
- Adult
Aflatoxins
Aged
Anticarcinogenic Agents adverse effects
Carcinoma, Hepatocellular chemically induced
China
Dose-Response Relationship, Drug
Drug Administration Schedule
Drug Monitoring
Female
Hepatitis B complications
Hepatitis B drug therapy
Humans
Liver Neoplasms chemically induced
Male
Middle Aged
Pyrazines adverse effects
Thiones
Thiophenes
Anticarcinogenic Agents administration & dosage
Carcinoma, Hepatocellular prevention & control
Liver Neoplasms prevention & control
Pyrazines administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1055-9965
- Volume :
- 6
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 9107431