public health recommendations regarding the cancer-inhibiting potential of fresh fruits and vegetables. Studies continue to assess the relation of these foods, and their specific constituents, to the risk of a variety of cancers.

An NCI study, in an area of China whose population is at high risk for stomach cancer, noted protective effects for vegetables of the allium class, including garlic and onions. This year, a case-control study of stomach cancer in high- and low-risk areas of Italy also revealed protective effects related to the intake of garlic and other fresh vegetables, with both types of the major histologic types of stomach cancer being affected. A follow-up study is assessing the role of diet on precancerous lesions of the stomach (i.e., chronic atrophic gastritis, intestinal metaplasia, and dysplasia) in the high-risk area of China.

Esophageal cancer also occurs more often among

Chinese-Americans than Caucasian Americans. Dietary factors will be evaluated in Linxian, China, which has the world's highest rates of this cancer. In collaboration with scientists in China, a large-scale, five-year randomized intervention trial is underway to evaluate whether certain groups of vitamins and minerals can inhibit late-stage progression to cancer in a high-risk population with multiple micronutrient deficiencies.

Results of many epidemiologic and animal studies suggest that diet is an important risk factor in colon cancer. Since a randomized controlled trial with colon cancer as an endpoint could require a sample size greater than 100,000, an alternative approach is to study the recurrence rate of adenomatous colonic polyps. These polyps are suspected as precursor lesions of colon cancer and are easy to detect. Initiatives are underway to examine the effect of a low-fat, high-fiber diet on the recurrence rate of adenomatous polyps. This randomized controlled trial will require an estimated sample size of less than 2,000.

The National Cancer Advisory Board recommended that the NCI conduct a feasibility study to develop the methods for achieving dietary change among minority and less educated women, along with further consideration of intervention methods for non-minority participants. This phase is scheduled to be completed in three years. Should the study prove to be successful, NCI will initiate the Women's health Trial, with the overall long range objective of determining whether a low fat dietary pattern, designed to reduce total fat and saturated fat, and to increase the intake of fruits, vegetables, and grain products, can decrease the incidence of cancer in postmenopausal women. Primary objectives are to determine whether adoption of a low fat dietary pattern will reduce breast cancer incidence, reduce combined breast cancer and colo-rectal cancer incidence, and reduce total mortality including coronary heart disease.

The important relationship of diet and nutrition in the development of cancer has become well known through various research efforts. Laboratory studies have shown a cancer inhibitory function for various natural and synthetic nutrients in various models. These studies have been corroborated by human epidemiologic studies of nutrient intake, tissue levels, and

cancer incidence.

The objectives of these etiologic studies are to: (a) assess the role of fats, selenium, and vitamins A, E, and C in breast cancer development; and (b) evaluate the relation of intake of various nutrients to subsequent cancer, particularly breast, colon, and lung.

LIFESTYLE

Dietary changes--particularly toward lower fat and higher fiber diets--are believed to have considerable potential to reduce cancer; but the most effective means to effect these recommended changes needs research. One example of current research is the NCI/Giant Food Project designed to test how consumer information about the relationship between diet, cancer and other chronic diseases, such as informational brochures, in-store displays, shelf labeling and mass media campaigns, affects food purchasing habits. The results from this project are anticipated by the end of 1991.

The current NCI/Giant Foods project on the effectiveness of point-of-purchase dietary information is planned for expansion and dissemination to more food and diet-related channels. This project will involve work with private agencies, including food, drug and health-related firms and trade associations, to improve cancer prevention and control outcomes through product modifications and marketing practices designed to encourage consumer behavior consistent with cancer prevention.

Working with produce growers, The California Department of Health has launched a statewide community and media promotion, "5-A-Day-For Better Health", to increase consumption of fruits and vegetables. Print and electronic advertising, bag stuffers, food demonstration and recipes are among the wide range of project activities. NCI is considering expanding this to a national campaign.

NCI continues to study the health risks and benefits associated with hormonal replacement therapy (HRT). In a study of breast and endometrial cancers in Sweden, positive trends with increasing total duration of estrogen treatment were found for both cancers. The risk for breast cancer was not changed with the addition of cyclic progestins to the treatment regime. However, no significant risk for endometrial cancer occurred when estrogen was opposed by progestins. Studies will continue to evaluate the risk and benefits (e.g., prevention of osteoporosis and cardiovascular disease) of HRT, providing baseline data for policy-making in this important area of public health.

Analyses of data from the Surveillance, Epidemiology and End Results (SEER) program, which covers cancer registration for about 10 percent of the U.S. population, revealed rising trends in the incidence of adenocarcinomas of the esophagus and gastric cardia. The increases averaged 4-10 percent per year from 1976 to 1987, exceeding those of any other cancer. The cancers

disproportionately affected white males, and rarely occurred in women. By the mid-1980's, adenocarcinomas accounted for about one-third of all esophageal cancers, while cardia cancers

accounted for about one-half of all stomach cancers with specified

subsites among white males. A new initiative will investigate the rising incidence and unusual demographic patterns of these poorly understood cancers, including the role of lifestyle.

This

Among whites the incidence of malignant melanoma has increased at a rate 4.4 percent each year over the period 1973-87, giving an overall increase of 79 percent. This increase has been faster than for any other major cancer in whites. Dysplastic nevi have been identified as a precursor lesion in 90 percent of familial melanomas and serves as a marker of predisposition. finding indicates that physicians should examine all available family members for the presence of nevi and melanoma, and institute periodic medical surveillance and preventive measures to reduce sunlight exposure and sunburns. Studies will continue to be pursued to isolate the susceptibility gene, which will aid in genetic screening for predisposition to melanoma, and to clarify the array of environmental and host factors contributing to melanoma.

The

NCI is also involved in designing and identifying the most effective strategies for bringing cancer methods and information to the public and to the nation's health care professionals. research identifies and develops strategies to surmount the barriers limiting the full transfer of new scientific results to practice. Objectives are also designed to foster cancer control research across the country utilizing state and local health authorities in developing cancer control plans for their regions and making maximal use of existing data on cancer.

Staff working in public health agencies or in offices and clinics who serve public health populations need the benefit of training, tested intervention materials and office systems to properly use such materials. The ethnic and low literacy initiative involves the development of nutrition materials by Hispanic, Black, Asian, Native American, Hawaiian professionals for use in physician offices and clinics serving these populations. Initial materials are expected in 1991. A primary care nutrition guide is completed and ready for assessment.

A program entitled Prescribe for Health is designed to increase the adoption and continued use of screening tests by primary care providers. This program will work through intermediary organizations organizations with influence over the routine practice of primary care medicine such as Health Maintenance Organizations, professional societies, and medical insurance companies. The two screening activities required for initial implementation will be breast and cervical screening. additional screening practices will be added as the program develops. The target population for the products of the study will be persons who visit primary care physicians, covering over 70 percent of the United States population each year. It is anticipated that a successful demonstration during this effort will become a wider application activity.

Two

Studies by NCI and other groups have shown a relation between exposure to environmental tobacco smoke (ETS) and lung cancer, particularly among nonsmoking women married to smokers. These findings have increased public awareness of the hazards associated

with ETS, and have influenced public policy regarding the regulation of smoking in public places. Further studies are planned to evaluate the risks of ETS and other environmental pollutants in the etiology of respiratory cancer.

The Community Intervention Trial For Smoking Cessation (COMMIT) is the largest smoking intervention study in the world, involving some two million people directly, and millions more indirectly. COMMIT is testing whether a community-based intervention protocol can be effectively disseminated nationwide to meet NCI's year 2000 objective to reduce smoking prevalence. The COMMIT design involves 11 pairs of communities in North America that were matched in size, demographics, and location.

The American Stop Smoking Intervention Study for Cancer Prevention (ASSIST) represents a collaborative effort between the National Cancer Institute, the American Cancer Society, State and local health departments and other voluntary organizations to develop comprehensive tobacco control programs in up to 20 states and metropolitan areas. The ASSIST intervention model is based on proven smoking prevention and control methods developed within the National Cancer Institute's intervention trials and other smoking and behavioral research. The purpose of ASSIST is to demonstrate that the wide-spread, coordinated application of the best available strategies to prevent and control tobacco use will significantly accelerate the current downward trend in smoking and tobacco use, thereby reducing the number and rate of tobacco-related cancers in the United States.

The "Tobacco Policy Interventions in Northwest Indian Tribes" project will develop and evaluate a consultative process and materials that will assist tribal councils in creating and implementing more explicit, comprehensive and stringent tobacco use policies. The primary outcome measures will be the extent and comprehensiveness of (a) tribal tobacco use policies and (b) the implementation process including amount of tribal publicity and activity regarding smoking related issues.

A project entitled "Por La Vida Model in Cancer Prevention" will evaluate the effectiveness of the Por La Vida model used by the National Heart, Lung and Blood Institute to promote behavior change to reduce cardiovascular risk factors and adapt it to a cancer risk reduction intervention. This grant-based study will expand the model to address cancer prevention and control in an area of San Diego. The general design is to promote better health among residents of a predominantly Mexican American community. Its original focus was on the reduction of cardiovascular disease risk factors among Hispanic women. This grant will stress increased use of mammography, increased use of PAP smears, breast self-exams, and changes in dietary habits appropriate for MexicanAmerican women. Some 500 Mexican American women are to be randomly recruited and randomized to one of two groups: cancer prevention intervention or community skills intervention. The intervention involves a series of group sessions stressing either cancer prevention (including the role of fat in cancer, screening, and smoking) or community living skills, such as communication, language, and time management. One of the key outcome measures will be changes in the frequency of breast and cervical cancer

screening. The grant will address such barriers as the availability of services and language.

A three-part motivational program for Head Start mothers is under evaluation. The impact of this program on the proportion of mothers (Black American women 18-40 years old) who either quit smoking or reduced their consumption will be evaluated. Self-reporting and follow-up data will be collected. Half of the 300 participating mothers will compose an experimental group, and half will compose a control group. It is anticipated that approximately 50 women will refuse the program. consist of one Head Start program in each of 20 schools.

The program will

The workplace is an obvious channel for cancer control activities aimed both at reducing occupational exposures and modifying unhealthy lifestyle choices. Research is underway to explore the potential of the worksite to improve a broad set of cancer prevention and control behaviors. The Working Well cooperative agreement is a large, Phase III project involving four research centers, a coordinating center and 120 randomized worksites. The project is designed to determine effective worksite-based intervention methods to reduce tobacco use, achieve cancer preventive dietary modification, increase screening prevalence, and reduce occupational exposures. Smaller worksite-based projects will develop mechanisms to assist worksite wellness managers to choose appropriate cancer control materials and develop interactive computer-based nutrition self-help programs.

The Community Clinical Oncology Program (CCOP), initiated in the fall of 1983, is a major cancer control effort which links community-based physicians with clinical cooperative groups and Cancer Centers (as research bases) for participation in NCI-approved research. The objectives of the CCOP include the development of research trials for effective implementation of cancer treatment and prevention and control research in multi-institutional settings, the testing of intervention strategies such as chemoprevention in large populations, and the assessment of the impact of targeted research on community practices.

One way to develop and implement effective treatment and cancer control strategies in minority populations, and thereby reduce disparities in cancer incidence, morbidity, and survival rates between whites and minority populations, is the participation of minority populations in the conduct of clinical trials. Since the CCOP model is an effective mechanism for linking investigators and their institutions with the clinical trials network, a Minority-Based CCOP (MBCCOP) was initiated to provide minority cancer patients with access to state-of-the-art cancer treatment and control technology. Twelve programs with greater than 50 percent of new cancer patients from minority populations were funded for the next three years. Through this effort, NCI aims to meet a need of minority cancer patients and individuals at risk for cancer by establishing a system of oncology programs for participation in clinical research trials through the NCI network. An evaluation of the MBCCOP is under way using the methodology developed in the CCOP evaluation.