CancerNCT03410641
Long-term Cancer Risk in the Randomised Oslo Diet and Antismoking Study
An observational study of Cancer and Gastrointestinal Cancer, run by Oslo University Hospital.
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… Read more about this study
- Who is it for?
- Ages 40 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer, Gastrointestinal Cancer, Lung Cancer
- What is being tested?
- Diet and antismoking advice
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,216 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 1972to 30 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 49 years
- Men only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: The Effect of Lifestyle Intervention on the Risk of Cancer - A Study of Participants in the 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.
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.
- Being tested
- Diet and antismoking advice
- Keywords
- cancer risk, randomised trial, intervention, smoking cessation, dietary intervention, weight loss
- Medical subject headings
- Neoplasms, Gastrointestinal Neoplasms, Lung Neoplasms, Urologic Neoplasms, Prostatic Neoplasms, Smoking Cessation, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet and antismoking adviceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Diet and antismoking advice | Dietary and antismoking advice, aiming to reduce participant's risk of cardiovascular diseases Receives: Behavioral: Diet and antismoking advice | |
| Control | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 43 years
Secondary outcomes (7)
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
Measured: 43 years
Cancer incidence
Any cancer diagnosis, drawn from the Cancer Registry of Norway
Measured: 43 years
Cancer mortality
Mortality in any cancer, drawn from the Norwegian Cause of Death Registry
Measured: 43 years
Incidence of gastrointestinal cancer
Diagnosis of carcinoma in gastro-intestinal tract, drawn from the Cancer Registry of Norway
Measured: 43 years
Incidence of lung cancer
Diagnosis of carcinoma in lung, drawn from the Cancer Registry of Norway
Measured: 43 years
Incidence of urinary tract cancer
Diagnosis of carcinoma in urinary tract, drawn from the Cancer Registry of Norway
Measured: 43 years
Incidence of prostate cancer
Diagnosis of carcinoma in prostate, drawn from the Cancer Registry of Norway
Measured: 43 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start15 Jan 1972
- Primary completion30 Jun 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula Berstad, Oslo University Hospital
- Investigators
- Paula Berstad, PhD, Principal investigator, Norwegian Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410641
- Sponsor's protocol ID
- 2016/1442
- Status last verified
- Jan 2018
- First submitted
- 8 Jan 2018
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lifestyle Intervention on the Risk of Cancer - A Study of Participants in the Oslo Diet and Antismoking Study
- ClinicalTrials.gov ID
- NCT03410641
- Acronym / sponsor ID
- 2016/1442
- Keywords
- cancer risk, randomised trial, intervention, smoking cessation, dietary intervention, weight loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,216 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 15 Jan 1972 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 25 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet and antismoking advice | – | Behavioral: Diet and antismoking adviceDietary and antismoking advice, aiming to reduce participant's risk of cardiovascular diseases |
| Control | – | –No intervention |
Who may qualify
- Ages
- 40 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet and antismoking adviceDietary 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. | Behavioural | Diet and antismoking advice |
Primary outcome
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
7 secondary outcomes
Mortality in the group of cancers related to smoking, diet or body mass index
Time frame: 43 years
Cancer incidence
Time frame: 43 years
Cancer mortality
Time frame: 43 years
Incidence of gastrointestinal cancer
Time frame: 43 years
Incidence of lung cancer
Time frame: 43 years
Incidence of urinary tract cancer
Time frame: 43 years
Incidence of prostate cancer
Time frame: 43 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula Berstad, PhD principal investigator
Norwegian Institute of Public Health
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Gastrointestinal Cancer, run by Oslo University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of the group of cancers related to smoking, diet or body mass index (time frame: 43 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.