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NCT Number: NCT03410641

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

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.

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Key information

Conditions

Cancer Behavior Body Weight Body Weight Changes Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Health Behavior Lung Cancer Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Smoking Cessation Thoracic Neoplasms Urinary Tract Cancer Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Weight Loss

Age range

40 year–49 year

Sex eligibility

Male

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet and antismoking advice

Behavioral

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.

Primary outcomes

  1. Incidence of the group of cancers related to smoking, diet or body mass index

    Time frame: 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 outcomes

  1. Mortality in the group of cancers related to smoking, diet or body mass index

    Time frame: 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

  2. Cancer incidence

    Time frame: 43 years

    Any cancer diagnosis, drawn from the Cancer Registry of Norway

  3. Cancer mortality

    Time frame: 43 years

    Mortality in any cancer, drawn from the Norwegian Cause of Death Registry

  4. Incidence of gastrointestinal cancer

    Time frame: 43 years

    Diagnosis of carcinoma in gastro-intestinal tract, drawn from the Cancer Registry of Norway

  5. Incidence of lung cancer

    Time frame: 43 years

    Diagnosis of carcinoma in lung, drawn from the Cancer Registry of Norway

  6. Incidence of urinary tract cancer

    Time frame: 43 years

    Diagnosis of carcinoma in urinary tract, drawn from the Cancer Registry of Norway

  7. Incidence of prostate cancer

    Time frame: 43 years

    Diagnosis of carcinoma in prostate, drawn from the Cancer Registry of Norway

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
1972
Primary completion
2017
Study completion
2017
First posted
Jan 25, 2018
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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