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Randomized trial with fruits and vegetables in prevention of cancer
Keyvan Tadjalli-Mehr1, Nikolaus Becker, Mati Rahu
1German Cancer Research Centre, Division of Clinical Epidemiology, Heidelberg, Germany.
Abstract:
Along with tobacco use, diet has the greatest impact on the development of human cancer. Within the broad category 'diet', the consumption of fruits and vegetables apparently plays a dominant role. Considerable efforts have been made to prove the preventive effect of different kinds of fruits and vegetables but randomized chemoprevention trials have failed to prove this presumed effectiveness of their single ingredients. The conclusive demonstration of a cancer-protective effect of a high consumption of fruits and vegetables is considered to be impractical. However, current historical changes in Europe offer a unique opportunity to conduct such a randomized trial in specific European countries. This study describes the nutritional situation and the conditions of the health system in the Baltic countries as appropriate geographic areas and demonstrates some basic design issues of the trial for three variants of outcome assumptions. A realistic assumption would be that a trial needs about 30000 participants, an intervention period of 10 years and a subsequent follow-up time of 20 years. Annual costs could range between dollars 5 and dollars 10 million. A high intake of fruits and vegetables should be proven scientifically as a valid tool for cancer prevention. For a comparably short period the Baltic countries offer a time-window for a randomized trial. It is unlikely that the costs of such a trial would considerably exceed the costs of the available chemoprevention trials.
Insights
High fruit and vegetable intake may prevent cancer, but proving this is difficult. A large, long-term randomized trial in the Baltic countries could provide conclusive evidence for cancer prevention strategies.
Area of Science:
- Oncology
- Nutritional Science
- Public Health
Background:
- Diet, particularly fruit and vegetable consumption, is a major factor in cancer development.
- Previous randomized chemoprevention trials have not confirmed the cancer-preventive effects of single fruit and vegetable ingredients.
- Demonstrating the cancer-protective effect of high fruit and vegetable intake through traditional methods is considered impractical.
Purpose of the Study:
- To assess the feasibility of conducting a large-scale randomized trial on the cancer-preventive effects of high fruit and vegetable consumption.
- To describe the nutritional landscape and healthcare system in the Baltic countries as suitable locations for such a trial.
- To outline key design considerations for a randomized trial, including participant numbers, intervention duration, and follow-up periods.
Main Methods:
- The study proposes a randomized trial design, considering the unique historical context and opportunities in Baltic countries.
- It analyzes the nutritional situation and health system conditions in the Baltic region.
- Basic design issues are addressed, including participant numbers (approx. 30,000), intervention duration (10 years), and follow-up (20 years).
Main Results:
- The Baltic countries present a unique, time-limited opportunity for conducting a large-scale randomized cancer prevention trial.
- Estimated annual costs for such a trial range from $5 to $10 million.
- The projected costs are comparable to existing chemoprevention trials.
Conclusions:
- A high intake of fruits and vegetables needs scientific validation as a cancer prevention tool.
- The Baltic region offers a feasible setting for a large, long-term randomized trial to investigate the cancer-protective effects of fruit and vegetable consumption.
- Such a trial is crucial for establishing evidence-based dietary recommendations for cancer prevention.
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