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

Completed

• Conditions: Lung Cancer; Urinary Tract Cancer; Cancer; Gastrointestinal Cancer; Prostate Cancer
• Interventions: Behavioral: Diet and antismoking advice

• Registration Number: NCT03410641
• Lead Sponsor: Oslo University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 1972-01-15
• Primary Completion: 2017-06-30
• Study Completion: 2017-09-30
• Status Verified: 2018-01
• Study First Submitted: 2018-01-08
• Study First Submitted QC: 2018-01-18
• Last Update Submitted: 2018-01-18
• Study First Posted: 2018-01-25
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1216

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diet and antismoking advice	Diet and antismoking advice	Dietary and antismoking advice, aiming to reduce participant's risk of cardiovascular diseases

Primary Outcome Measures

Name	Time	Method
Incidence of the group of cancers related to smoking, diet or body mass index	43 years	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

Secondary Outcome Measures

Name	Time	Method
Mortality in the group of cancers related to smoking, diet or body mass index	43 years	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
Incidence of lung cancer	43 years	Diagnosis of carcinoma in lung, drawn from the Cancer Registry of Norway
Incidence of prostate cancer	43 years	Diagnosis of carcinoma in prostate, drawn from the Cancer Registry of Norway
Cancer incidence	43 years	Any cancer diagnosis, drawn from the Cancer Registry of Norway
Incidence of gastrointestinal cancer	43 years	Diagnosis of carcinoma in gastro-intestinal tract, drawn from the Cancer Registry of Norway
Cancer mortality	43 years	Mortality in any cancer, drawn from the Norwegian Cause of Death Registry
Incidence of urinary tract cancer	43 years	Diagnosis of carcinoma in urinary tract, drawn from the Cancer Registry of Norway