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Beyond The Abstract Dietary Modification In Patients With Prostate Cancer On Active Surveillance: A Randomized, Multi Centre Feasibility Study
To our knowledge, this is the first clinical trial to report the
application of a major, validated, diet-based intervention as a single
form of therapy in active surveillance patients. These data indicate
that telephone-based counseling emphasizing a plant-based diet
significantly increases vegetable intake and plasma concentrations of
potentially anti-carcinogenic carotenoids among men with prostate cancer
on active surveillance.
Prostate cancer patients in large numbers are experimenting with
complementary and alternative medicine, including diet [19]. Assessing
the clinical efficacy of dietary change is an important public health
issue and requires the accumulation of data from rationally-designed
trials focused on feasible diet-based interventions. Unlike the present
study, the intensive lifestyle modifications and face-to-face counseling
employed in the prior study of diet and active surveillance patients
[15] requires substantial resource commitments that may be difficult to
implement and sustain on a larger scale.
Diet change represents an innovative approach to refining treatment
paradigms for lower risk prostate cancer. Active surveillance patients
are a particularly compelling study population in this regard for
several reasons. First, approximately 100,000 men are diagnosed with
lower-risk prostate cancer every year in the U.S.; thus, treatment
benefits for this population would have important ramifications for
public health. Second, because up to 30% of men on active surveillance
may progress [7], reducing this proportion represents a realistic
therapeutic goal. Third, these patients are not receiving active therapy
(i.e., radiation, surgery, or androgen deprivation) that would otherwise
obscure or confound beneficial effects of dietary change on prostate
cancer progression. Finally, these patients would likely be receptive to
relatively simple nutritional interventions with proven benefits to
cardiovascular and overall health.
Indeed, because prostate cancer diagnosis is a source of
considerable anxiety and diminished quality of life for many patients
diagnosed with lower-risk disease [20], it is possible that dietary
change would not only exert therapeutic biological effects, but would
also encourage men with lower risk prostate cancer and no signs of
progression to remain in an active surveillance program. Many patients
with no objective PSA or pathologic criteria for progression will
nonetheless opt for treatment [7]. Treatment preferences in this
situation are generally believed to arise from patient discomfort over
not receiving curative therapy for a cancer diagnosis.
For these patients, a diet change program presents an opportunity
to alter their perceptions of lower risk prostate cancer by providing an
intervention or therapy on which to focus, thereby easing their
discomfiture and possibly dissuading otherwise lower risk men from
pursuing unnecessarily aggressive, morbidity-generating treatments. Such
an approach would promulgate a novel therapeutic paradigm for lower risk
prostate cancer akin to diet alterations for non-insulin dependent
diabetes: medical management, without curative intent, of a chronic
disease state.
Our innovative telephone-based counseling program focuses on
beneficial dietary components associated with decreased prostate cancer
incidence and progression. The counseling protocol is step-wise and
phased; it employs strategies adopted from social cognitive theory [21,
22] using the techniques of motivational interviewing [23]. It is
practicable, demands few resource commitments for the patient, and is
low-cost for relatively large study populations. A similar program has
proved efficacious in breast cancer patients: the Women's Healthy Eating
and Living (WHEL) Study produced significant diet changes and plasma
carotenoid increases over 12 months that have been maintained for 4
years in over 1,500 women previously diagnosed. The significance of the plasma carotenoid increases in the intervention group is underscored by a comparison of these results to those of another major dietary intervention: the Polyp Prevention Trial [25]. Although MEAL study participants began with total carotenoid concentrations 30% higher than those of Polyp Prevention
Trial participants, the proportional increase in intervention group
carotenoid concentrations in MEAL was almost twice that achieved in the
first year of the Polyp Prevention Trial.
Several caveats of these results are worth addressing. First, although
dietary self-reporting methods may be susceptible to systematic
measurement error [26], plasma carotenoid concentrations are an
effective biomarker for dietary intake of carotenoids and serve as an
objective indicator of a vegetable-intense diet [27]. Moreover,
carotenoids have been associated with reduced risk of incident prostate
cancer [28, 29] and diminished oxidative damage in prostate tissue [30].
Second, while these results do not prove that the changes in diet intake
and plasma carotenoid concentrations observed over a 6-month period will
be maintained over a longer period of time, the WHEL Study findings
suggest that diet changes observed in the first 6 months of this
intervention will be maintained for at least 4 years [24].
Third, although these results do not prove that changes in diet and
plasma carotenoid concentrations will necessarily alter the natural
history of prostate cancer, it is reasonable to hypothesize that these
diet changes increased total vegetable, cruciferous vegetable, and
tomato intakes will decrease disease progression in active surveillance
patients, given the extensive observational and pre-clinical data
supporting this concept. Moreover, it is important to note that the
rationale for trials of diet intervention and prostate cancer is driven
not only by the supposition that diet plays a significant role in
prostate cancer carcinogenesis, but also by the widespread desire of
patients to know whether dietary change has any value in disease
control.
Finally, although PSA concentrations did not change appreciably
during the duration of the study, this trial was neither powered nor
designed to examine PSA changes as a primary endpoint, which would
require determination of PSA kinetics (doubling time or velocity) over a
longer time period [7]. Our main purpose in this feasibility study was
to test the hypothesis that a telephone-based counseling intervention
would produce diet and plasma carotenoid changes in prostate cancer
patients not to assess whether these changes would alter the natural
history or clinical progression of prostate cancer in an active
surveillance population.
In summary, these data support the feasibility of implementing
clinical trials of telephone-based dietary interventions in men with
prostate cancer on active surveillance. Future, larger studies should
utilize PSA changes as a primary endpoint to test the hypothesis that
telephone-based diet changes will decrease disease progression and need
for conventional treatment in these patients.
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J. Kellogg Parsons, MD, MHS
Assistant Professor of Surgery/Urology
Staff Investigator Moores Cancer Center
University of California San Diego
Link to full abstract
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Dincolo de abstract dietetice Modificari la pacienþii cu cancer de prostatã pe active de supraveghere: Un studiu randomizat, multi Centrul de studiu de fezabilitate - Beyond The Abstract Dietary Modification In Patients With Prostate Cancer On Active Surveillance: A Randomized, Multi Centre Feasibility Study - articole medicale engleza - startsanatate