Long-term Cancer Risk in the Randomised Oslo Diet and Antismoking Study

Study Overview
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Brief Summary
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This study examines the effect of a five-year multifactorial lifestyle intervention in the Oslo diet and antismoking study on long-term cancer risk. In 1972-1973, 1232 men with high cardiovascular risk profile were randomised to intervention including cholesterol lowering diet, weight loss and antismoking advice, or control (1:1). This study examines the effect of the intervention on 43-year cancer incidence and mortality.

Detailed Description
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The Oslo diet and antismoking study showed that a 5-year lifestyle intervention reduced the long-term risk of coronary events and mortality. The lifestyle risk factors for cancer are partly similar to those for coronary heart disease, e.g. smoking, high body weight, unfavourable diet. The investigators therefore expect that the intervention has an effect on cancer risk in the long term. In this follow-up study, the investigators analyse the association between the intervention, and cancer incidence and mortality drawn from the Cancer Registry of Norway and the Norwegian Cause of Death Registry from the time of randomisation in 1972/3 until the end of 2015.

Official Title
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The Effect of Lifestyle Intervention on the Risk of Cancer - A Study of Participants in the Oslo Diet and Antismoking Study

Conditions
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Cancer, Gastrointestinal Cancer, Lung Cancer, Urinary Tract Cancer, Prostate Cancer

Intervention / Treatment
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* Behavioral: Diet and antismoking advice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: participated in screening of coronary risk factors, into which all men born in 1923-1932 and living in Oslo were invited in 1972-1973 being in the upper quartile of a coronary risk score based on blood pressure, serum total cholesterol concentration and cigarette smoking Exclusion Criteria: serum total cholesterol level above 9.0 mmol per Liter having a healthy diet, based on a short dietary history self-reported cardiovascular disease or diabetes previous history of cancer

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diet and antismoking advice<br>Dietary and antismoking advice, aiming to reduce participant's risk of cardiovascular diseases | Behavioral: Diet and antismoking advice<br>* Dietary advice with the aim of reducing participant's serum cholesterol levels, including reduction in the intake of saturated fat and cholesterol, and increased intake of polyunsaturated fat, fish, vegetables and fruit. Weight reduction was recommended for overweight men, as well as reduced consumption of sugar rich foods and drinks, and alcoholic beverages. Smokers were advised to stop smoking. The advice was given both individually and in group sessions during a five-year time period from 1972/3 until 1977/8.<br>|
| Control<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of the group of cancers related to smoking, diet or body mass index | Diagnosis of carcinoma in the oral cavity, oropharynx, esophagus, stomach, colorectum, liver and intrahepatic bile ducts, pancreas, larynx, trachea, bronchus and lung, urinary tract and thyroid gland, drawn from the Cancer Registry of Norway | 43 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality in the group of cancers related to smoking, diet or body mass index | Mortality in cancers in the oral cavity, oropharynx, esophagus, stomach, colorectum, liver and intrahepatic bile ducts, pancreas, larynx, trachea, bronchus and lung, urinary tract and thyroid gland, drawn from the Norwegian Cause of Death Registry | 43 years | 
| Cancer incidence | Any cancer diagnosis, drawn from the Cancer Registry of Norway | 43 years | 
| Cancer mortality | Mortality in any cancer, drawn from the Norwegian Cause of Death Registry | 43 years | 
| Incidence of gastrointestinal cancer | Diagnosis of carcinoma in gastro-intestinal tract, drawn from the Cancer Registry of Norway | 43 years | 
| Incidence of lung cancer | Diagnosis of carcinoma in lung, drawn from the Cancer Registry of Norway | 43 years | 
| Incidence of urinary tract cancer | Diagnosis of carcinoma in urinary tract, drawn from the Cancer Registry of Norway | 43 years | 
| Incidence of prostate cancer | Diagnosis of carcinoma in prostate, drawn from the Cancer Registry of Norway | 43 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer risk, randomised trial, intervention, smoking cessation, dietary intervention, weight loss