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CompletedNCT03410641Updated Jan 25, 2018

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

An observational study in Cancer, Gastrointestinal Cancer and Lung Cancer, sponsored by Oslo University Hospital. Completed. Open to male participants aged 40 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-25.

Sponsored by Oslo University Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
1,216
Ages
40 Years to 49 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Cancer
  • Gastrointestinal Cancer
  • Lung Cancer
  • Urinary Tract Cancer
  • Prostate Cancer

Keywords

  • cancer risk
  • randomised trial
  • intervention
  • smoking cessation
  • dietary intervention
  • weight loss
03

Who can participate

Ages eligible
40 Years to 49 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The participants selected for this follow-up study (n=1216) are the eligible subjects of the 1232 men at high cardiovascular risk profile who participated in the Oslo Diet and Antismoking Study (included in 1972-73). Fourteen men were excluded because they did not consent to studies other than the main study, and two more because of previous history of cancer.

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

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
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
1,216 participants (actual)
Patient registry
No

Groups and cohorts

  • Diet and antismoking advice

    Dietary and antismoking advice, aiming to reduce participant's risk of cardiovascular diseases

    Behavioral: Diet and antismoking advice

  • Control

    No intervention

Interventions

  • BehavioralDiet 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.

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 43 years

Secondary outcomes

  1. 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

    Time frame: 43 years

  2. Cancer incidence

    Any cancer diagnosis, drawn from the Cancer Registry of Norway

    Time frame: 43 years

  3. Cancer mortality

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

    Time frame: 43 years

  4. Incidence of gastrointestinal cancer

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

    Time frame: 43 years

  5. Incidence of lung cancer

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

    Time frame: 43 years

  6. Incidence of urinary tract cancer

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

    Time frame: 43 years

  7. Incidence of prostate cancer

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

    Time frame: 43 years

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03410641
Lead sponsor
Oslo University Hospital
Responsible party
Paula Berstad (Principal Investigator, Oslo University Hospital) — Principal investigator
First posted
Jan 25, 2018
Start date
Jan 15, 1972
Primary completion
Jun 30, 2017
Completion
Sep 30, 2017
Last update
Jan 25, 2018

Study contacts

Paula Berstad, PhD
principal investigator · Norwegian Institute of Public Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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