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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03410641
• Other study ID #: 2016/1442
• Status: Completed
• Phase: N/A
• First received: January 8, 2018
• Last updated: January 18, 2018
• Start date: January 15, 1972
• Est. completion date: September 30, 2017

Study information

• Verified date: January 2018
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1216
• Est. completion date: September 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Lung Cancer
• Prostate Cancer
• Urinary Tract Cancer
• Urologic Neoplasms

Intervention

Behavioral:
• Diet and antismoking advice
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Cancer incidence	Any cancer diagnosis, drawn from the Cancer Registry of Norway	43 years
Secondary	Cancer mortality	Mortality in any cancer, drawn from the Norwegian Cause of Death Registry	43 years
Secondary	Incidence of gastrointestinal cancer	Diagnosis of carcinoma in gastro-intestinal tract, drawn from the Cancer Registry of Norway	43 years
Secondary	Incidence of lung cancer	Diagnosis of carcinoma in lung, drawn from the Cancer Registry of Norway	43 years
Secondary	Incidence of urinary tract cancer	Diagnosis of carcinoma in urinary tract, drawn from the Cancer Registry of Norway	43 years
Secondary	Incidence of prostate cancer	Diagnosis of carcinoma in prostate, drawn from the Cancer Registry of Norway	43 years