Prostate CancerNCT01300104
Feasibility Study on a Nordic Lifestyle Intervention Trial Among Men With Prostate Cancer
A study testing Exercise, Whole grain rye and Recommendations in people with Prostate Cancer, run by Danish Cancer Society at 4 sites in Denmark.
Trial summary
PURPOSE: To evaluate the feasibility of a future Nordic intervention trial, including vigorous activity and a high intake of whole grain rye, among prostate cancer patients on active surveillance. Read more about this study
- Who is it for?
- Ages 55 to 70 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Exercise, Whole grain rye and Recommendations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 4 sitesDenmark
- Study dates
- Feb 2011to Feb 2015
- Phase
- Interventional
- 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 55 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proven prostate cancer within 2 years prior to enrolment
- PSA ≤ 10 ng/ml, Gleason-score ≤ 6, clinical localized prostate cancer ≤ cT2a or PSA ≤ 10 ng/ml, Gleason-score ≤ 7, clinical localized prostate cancer ≤ cT2a.
- Maximum 1/5 tumor positive biopsy rate
- On active surveillance (elected to forgo treatment)
- Level of testosterone normal in sera
Who cannot join
- Prior history of cancer, except for non-melanoma skin cancer, unless considered cured without signs of treatment failure for at least five years
- Less than 10 years of life expectancy
- Conditions or behaviors likely to affect the capability of participating fully in the intervention
- Moderate to severe co-morbidity (kidney, liver, heart or respiratory problems) or the general physical constitution
- Gluten intolerance
- Inflammatory bowel disease (e.g. Crohn, colitis)
- Physical handicaps
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Aarhus University, Institute of Sport Science
Aarhus, 8000
Counseling Center, Danish Cancer Society
Aarhus, 8000
Aarhus University Hospital Skejby
Aarhus, 8200
Danish Cancer Society
Copenhagen, 2100
About this study
Official title: Feasibility Study on a Nordic Lifestyle Intervention Trial Investigating the Effect of Vigorous Activity and Intake of Whole Grain Rye on Cancer Progression, Insulin Sensitivity and Inflammation Among Men With Early Stage Prostate Cancer.
PURPOSE:
To evaluate the feasibility of a future Nordic intervention trial, including vigorous activity and a high intake of whole grain rye, among prostate cancer patients on active surveillance.
Additionally, to investigate effects of the lifestyle intervention according to cancer progression, the metabolic profile, inflammation and quality of life among prostate cancer patients on active surveillance.
Read the detailed description
In the present feasibility study it will be established whether it is possible to enroll participants for this particular kind of intervention among this particular patient group, and if compliance with the intervention is possible to gain by the tools planned: individual counselling with a dietician and a physiologist, interviews on diet, exercise tests and diaries on diet, exercise and steps taken.
Furthermore, the investigators will investigate if we are able to detect effects of the lifestyle intervention according to cancer progression, the metabolic profile, inflammation and quality of life among the participants (24 men) within the short intervention period (6 months) for this particular feasibility study.
Biomarkers of effect and compliance are measured in blood, urine and prostate tissue samples. Metabolomics and the following biomarkers are measured in blood and urine samples: Alkyl resorcinols, enterolactone, tnf receptor 2, e-selectin. ICAM1, IL1-alpha, IL6, triglycerides, HDL/LDL, s-insulin, HbA1c, C-peptide, CRP, IGF1, GLP1, cholesterol, cathepsin and glucose.
- Conditions
- Prostate Cancer
- Being tested
- Exercise, Whole grain rye, Recommendations
- Keywords
- prostate cancer progression, active surveillance, whole grain rye, exercise, insulin sensitivity, quality of life
- Medical subject headings
- Prostatic Neoplasms, Motor Activity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Prescriptions: Vigorous exercise (average 65-70% of maximal oxygen consumption) minimum 3 times 45 minutes per week according to customized endurance training programs.
Restrictions: None.
Whole grain ryeBehavioural
Prescriptions: Minimum 170-180g of whole grain rye intake per day. Restrictions: None.
RecommendationsBehavioural
Recommendations on a health-promoting, energy restricted diet according to Danish Nutrition Recommendations and encouraged to walk at least 10,000 steps every day.
| Study group | Role | What they receive |
|---|---|---|
| Exercise and whole grain rye | Experimental | Not described Receives: Behavioral: Exercise; Behavioral: Whole grain rye; Behavioral: Recommendations |
| No prescriptions | Active comparator | Not described Receives: Behavioral: Recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of a planned Nordic life style intervention
Feasibility of an intervention trial is evaluated among Danish men with early stage prostate cancer. Enrollment of participants, possible for this particular type of trial among the particular patient group? Compliance with intervention, obtainable for intervention participants with the tools planned (counseling sessions, exercise programs, supply of rye products, sphygmographs and pedometers)? Does the design minimize drop out? Is the schedule for monitoring, counseling, testing and collection of biological samples efficient and feasible for the research team and for the participants?
Measured: Five years
Secondary outcomes (5)
Prostate cancer progression, effect of the life style intervention
PSA is measured at baseline and 3, 6 and 12 months after baseline among all participants. Prostate biopsies are made at baseline and 6 months after baseline among all participants.
Measured: One year
Insulin sensitivity and insulin secretion, effect of the life style intervention
Oral glucoce tolerance test is made among all participants at baseline, and 3, 6 and 12 months after baseline.
C peptide levels will be measured in 24h urine samples the following year after the intervention. The urine samples are collected at baseline, and 3, 6 and 12 months after baseline from all participants.
Measured: One year
Life quality, effect of the life style intervention
Life quality is evaluated by questionnaires answered by all participants at baseline, and 6 and 12 months after baseline.
Measured: One year
Metabolic profile, effect of the life style intervention
The following measurements are made at baseline, and 3, 6 and 12 months after baseline among all participants: Bioimpedance, skin fold analysis, waist and hip circumference, weight and height, and blood pressure.
Measured: One year
Inflammation, effect of the life style intervention
CRP is measured among all participants at baseline, and 3, 6 and 12 months after baseline.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Cancer Society
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, University of Aarhus, European Commission
- Responsible party
- Principal investigator, Rikke Dalgaard Hansen, Danish Cancer Society
- Investigators
- Anne Tjønneland, Dr.Med.Sci., Study director, Danish Cancer Society Research CenterRikke D Hansen, Dr., Principal investigator, Danish Cancer Society Research CenterMichael Borre, Prof., Study director, Aarhus University Hospital Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300104
- Sponsor's protocol ID
- EC Grant agreement 242244
- Other IDs
- CHANCES
- Status last verified
- Feb 2015
- First submitted
- 18 Feb 2011
- Last updated
- 19 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Eriksen AK, Hansen RD, Borre M, Larsen RG, Jensen JM, Overgaard K, Borre M, Kyro C, Landberg R, Olsen A, Tjonneland A. A lifestyle intervention among elderly men on active surveillance for non-aggressive prostate cancer: a randomised feasibility study with whole-grain rye and exercise. Trials. 2017 Jan 13;18(1):20. doi: 10.1186/s13063-016-1734-1.
PubMed 28086943
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study on a Nordic Lifestyle Intervention Trial Investigating the Effect of Vigorous Activity and Intake of Whole Grain Rye on Cancer Progression, Insulin Sensitivity and Inflammation Among Men With Early Stage Prostate Cancer.
- ClinicalTrials.gov ID
- NCT01300104
- Acronym / sponsor ID
- EC Grant agreement 242244
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer progression, active surveillance, whole grain rye, exercise, insulin sensitivity, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Danish Cancer SocietyUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, University of Aarhus, European Commission
- Study start
- Feb 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 21 Feb 2011 (estimated)
- 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.
PURPOSE:
To evaluate the feasibility of a future Nordic intervention trial, including vigorous activity and a high intake of whole grain rye, among prostate cancer patients on active surveillance.
Additionally, to investigate effects of the lifestyle intervention according to cancer progression, the metabolic profile, inflammation and quality of life among prostate cancer patients on active surveillance.
Detailed description
In the present feasibility study it will be established whether it is possible to enroll participants for this particular kind of intervention among this particular patient group, and if compliance with the intervention is possible to gain by the tools planned: individual counselling with a dietician and a physiologist, interviews on diet, exercise tests and diaries on diet, exercise and steps taken.
Furthermore, the investigators will investigate if we are able to detect effects of the lifestyle intervention according to cancer progression, the metabolic profile, inflammation and quality of life among the participants (24 men) within the short intervention period (6 months) for this particular feasibility study.
Biomarkers of effect and compliance are measured in blood, urine and prostate tissue samples. Metabolomics and the following biomarkers are measured in blood and urine samples: Alkyl resorcinols, enterolactone, tnf receptor 2, e-selectin. ICAM1, IL1-alpha, IL6, triglycerides, HDL/LDL, s-insulin, HbA1c, C-peptide, CRP, IGF1, GLP1, cholesterol, cathepsin and glucose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise and whole grain rye | Experimental | Behavioral: Exercise, Behavioral: Whole grain rye, Behavioral: Recommendations |
| No prescriptions | Active comparator | Behavioral: Recommendations |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Biopsy proven prostate cancer within 2 years prior to enrolment
- PSA ≤ 10 ng/ml, Gleason-score ≤ 6, clinical localized prostate cancer ≤ cT2a or PSA ≤ 10 ng/ml, Gleason-score ≤ 7, clinical localized prostate cancer ≤ cT2a.
- Maximum 1/5 tumor positive biopsy rate
- On active surveillance (elected to forgo treatment)
- Level of testosterone normal in sera
Key exclusion criteria (7 listed)
- Prior history of cancer, except for non-melanoma skin cancer, unless considered cured without signs of treatment failure for at least five years
- Less than 10 years of life expectancy
- Conditions or behaviors likely to affect the capability of participating fully in the intervention
- Moderate to severe co-morbidity (kidney, liver, heart or respiratory problems) or the general physical constitution
- Gluten intolerance
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 |
|---|---|---|
| ExercisePrescriptions: Vigorous exercise (average 65-70% of maximal oxygen consumption) minimum 3 times 45 minutes per week according to customized endurance training programs. Restrictions: None. | Behavioural | Exercise and whole grain rye |
| Whole grain ryePrescriptions: Minimum 170-180g of whole grain rye intake per day. Restrictions: None. | Behavioural | Exercise and whole grain rye |
| RecommendationsRecommendations on a health-promoting, energy restricted diet according to Danish Nutrition Recommendations and encouraged to walk at least 10,000 steps every day. | Behavioural | Exercise and whole grain rye, No prescriptions |
Primary outcome
Feasibility of a planned Nordic life style intervention
Time frame: Five years
Feasibility of an intervention trial is evaluated among Danish men with early stage prostate cancer. Enrollment of participants, possible for this particular type of trial among the particular patient group? Compliance with intervention, obtainable for intervention participants with the tools planned (counseling sessions, exercise programs, supply of rye products, sphygmographs and pedometers)? Does the design minimize drop out? Is the schedule for monitoring, counseling, testing and collection of biological samples efficient and feasible for the research team and for the participants?
5 secondary outcomes
Prostate cancer progression, effect of the life style intervention
Time frame: One year
Insulin sensitivity and insulin secretion, effect of the life style intervention
Time frame: One year
Life quality, effect of the life style intervention
Time frame: One year
Metabolic profile, effect of the life style intervention
Time frame: One year
Inflammation, effect of the life style intervention
Time frame: One year
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 19 Feb 2015.
- Derived from this study: PubMed 28086943Eriksen AK, Hansen RD, Borre M, Larsen RG, Jensen JM, Overgaard K, Borre M, Kyro C, Landberg R, Olsen A, Tjonneland A. A lifestyle intervention among elderly men on active surveillance for non-aggressive prostate cancer: a randomised feasibility study with whole-grain rye and exercise. Trials. 2017 Jan 13;18(1):20. doi: 10.1186/s13063-016-1734-1.
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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.
Anne Tjønneland, Dr.Med.Sci. study director
Danish Cancer Society Research Center
Rikke D Hansen, Dr. principal investigator
Danish Cancer Society Research Center
Michael Borre, Prof. study director
Aarhus University Hospital Skejby
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Whole grain rye and Recommendations in people with Prostate Cancer, run by Danish Cancer Society at 4 sites in Denmark.
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 5 inclusion and 7 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 19 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Feasibility of a planned Nordic life style intervention (time frame: Five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01300104, which also lists 1 linked publication.
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 19 Feb 2015.