Open AccessA Pilot Study for a Randomized Controlled Trial to Prevent Gastric Cancer in High‐risk Japanese Population: Study Design and Feasibility Evaluation
Author(s) -
Tsugane Shoichiro,
Tsubono Yoshitaka,
Okubo Shunji,
Hayashi Masato,
Kakizoe Tadao
Publication year - 1996
Publication title -
japanese journal of cancer research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.035
H-Index - 141
eISSN - 1349-7006
pISSN - 0910-5050
DOI - 10.1111/j.1349-7006.1996.tb00276.x
Subject(s) - medicine , atrophic gastritis , randomized controlled trial , observational study , population , cancer , epidemiology , gastritis , surgery , gastroenterology , stomach , environmental health
Observational epidemiological studies suggest that some nutrients reduce the risk of gastric cancer and that individuals with atrophic gastritis are at high risk of developing gastric cancer. One possible measure for gastric cancer prevention is therefore nutritional supplementation for the high risk group. Before recommending this strategy for the general public, however, a randomized controlled trial (RCT) is necessary. To evaluate the feasibility of an RCT, the authors conducted a pilot study using recipients of a health check‐up program in a general hospital in Japan. The subjects who were asked to participate in the trial had been diagnosed as having atrophic gastritis on the basis of serum pepsinogen I <70 ng/ml and the ratio of pepsinogen I to II <3.0. They were requested to ingest double‐blinded capsules containing different levels of vitamin C and β‐carotene every day. Out of the 219 subjects (118 males, 101 females) who were eligible for the study and had the required pepsinogen measurement, 90 (41%) met the criteria for atrophic gastritis. Among them, 55 (61%) (35 males, 20 females) gave their informed consent to participate in the RCT. Fifty‐four participants completed a 3‐month course of supplementation, and all of them agreed to a 5‐year supplementation period. The authors concluded that an RCT using double‐blinded nutritional supplements and targeting apparently healthy individuals is feasible in an intervention study for cancer prevention in Japan.