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Randomized Controlled Trial
. 2017 Jan 13;18(1):20.
doi: 10.1186/s13063-016-1734-1.

A lifestyle intervention among elderly men on active surveillance for non-aggressive prostate cancer: a randomised feasibility study with whole-grain rye and exercise

Anne Kirstine Eriksen  1 , Rikke Dalgaard Hansen  2 , Michael Borre  3 , Ryan Godsk Larsen  4 , Jeppe Munthe Jensen  5 , Kristian Overgaard  5 , Mette Borre  6 , Cecilie Kyrø  2 , Rikard Landberg  7   8   9 , Anja Olsen  2 , Anne Tjønneland  2
Affiliations
Randomized Controlled Trial

A lifestyle intervention among elderly men on active surveillance for non-aggressive prostate cancer: a randomised feasibility study with whole-grain rye and exercise

Anne Kirstine Eriksen et al. Trials. .

Abstract

Background: The prognosis for men with non-aggressive prostate cancer is good, and several studies have investigated the impact of lifestyle changes including physical activity and diet on the prognosis. Despite positive results in animal studies and a few human interventions with whole-grain rye on markers of prostate cancer progression, the feasibility of trials investigating such dietary changes in combination with physical activity remains largely unstudied. The primary aim was to investigate the feasibility of an intervention with high whole-grain rye intake and vigorous physical activity for 6 months in men diagnosed with prostate cancer.

Methods: In total, 26 men (53-72 years) recently diagnosed with non-aggressive prostate cancer and on active surveillance, were enrolled in 2011-2012 and randomly assigned to an intervention or a control group. The intervention included 170 g/day of whole-grain rye and 3 × 45 minutes/week of vigorous physical activity. The duration of the intervention was 6 months and end of follow-up 12 months after baseline. Clinic visits were scheduled at baseline and 3, 6 and 12 months after baseline. Compliance with the intervention was evaluated by diaries, food frequency questionnaires, biomarkers, and heart rate monitor data. The effect of the intervention was evaluated by linear multiple regression analysis.

Results: In the intervention group, the mean daily intake of whole-grain rye measured from diaries was 146 g (SD: 19) for the first 3 months and 125 g (SD: 40) for the last 3 months of the intervention. The median level (5th and 95th percentiles) of vigorous physical activity was 91 (17, 193) min/week for the first 3 months and 66 (13, 259) min/week for the last 3 months. No recordings of physical activity were done for the control group. Aerobic fitness (VO2 peak) increased in the intervention group compared to the control group after the intervention. No effects were found on other cardio-metabolic outcomes or prostate cancer progression.

Conclusions: The lifestyle intervention appeared feasible for 6 months among Danish men and the results are encouraging for conducting full-scale studies, where the impact of whole-grain rye and vigorous physical activity on prostate cancer progression and metabolic parameters can be evaluated.

Trial registration: ClinicalTrials.gov, NCT01300104 . Registered on 18 February 2011.

Keywords: Feasibility; Intervention; Physical activity; Prostate cancer; Whole-grain rye.

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Figures

Fig. 1
Fig. 1
Flowchart of participants and drop-out in the NILS feasibility study
Fig. 2
Fig. 2
Physical activity in the intervention group, by heart rate monitors and diaries, for 26 weeks – the NILS feasibility study
Fig. 3
Fig. 3
PSA levels at baseline and 3, 6 and 12 months after baseline in the intervention (a) and the control (b) group in the NILS feasibility study
See this image and copyright information in PMC

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