The effects of exercise on body composition of prostate cancer patients receiving androgen deprivation therapy: An update systematic review and meta-analysis.

Androgen deprivation therapy is a common treatment for prostate cancer. However, this therapy is associated with various adverse effects, such as increased body fat and decreased bone mineral density. Exercise may be useful for ameliorating these adverse effects, although it is not completely effective. This review aimed to clarify how exercise interventions influenced body composition and bone mineral density and to explore the most effective exercise program among prostate cancer patients who received androgen deprivation therapy. We searched the PubMed, EMBASE, Web of Science, EBSCO, and Cochrane Library databases for reports of randomised controlled trials that were published until October 2021. All studies involved prostate cancer patients who received androgen deprivation therapy and completed aerobic exercise, resistance exercise, and/or impact exercise training. Outcomes were defined as lean body mass, body fat mass, body fat rate, regional and whole-body bone mineral density. Thirteen reports regarding 12 randomised clinical trials (715 participants) were included. Relative to the control group, exercise intervention provided a higher lean body mass (mean difference: 0.88, 95% confidence interval: 0.40 to 1.36, P<0.01), a lower body fat mass (mean difference: -0.60, 95% confidence interval: -1.10 to -0.10, P<0.05), and a lower body fat rate (mean difference: -0.93, 95% confidence interval: -1.39 to -0.47, P<0.01). Subgroup analyses revealed greater efficacy for exercise duration of ≥6 months (vs. <6 months) and exercise immediately after the therapy (vs. delayed exercise). No significant differences were observed in the bone mineral density outcomes. Exercise can help ameliorate the adverse effects of androgen deprivation therapy in body composition, with combination exercises including resistance exercise, 8-12 repetition maximum of resistance exercise intensity, prolonged exercise duration, and performing exercise immediately after therapy providing better amelioration. And the combination of resistance and impact exercise appears to be the best mode for improving the bone mineral density.

Different endurance exercises modulate NK cell cytotoxic and inhibiting receptors.

PURPOSE: Induction of IDO depends on the activation of AhR forming the AhR/IDO axis. Activated AhR can transcribe various target genes including cytotoxic and inhibiting receptors of NK cells. We investigated whether AhR and IDO levels as well as activating (NKG2D) and inhibiting (KIR2DL1) NK cell receptors are influenced by acute exercise and different chronic endurance exercise programs. METHODS: 21 adult breast and prostate cancer patients of the TOP study (NCT02883699) were randomized to intervention programs of 12 weeks of (1) endurance standard training or (2) endurance polarized training after a cardiopulmonary exercise test (CPET). Serum was collected pre-CPET, immediately post-CPET, 1 h post-CPET and after 12 weeks post-intervention. Flow cytometry analysis was performed on autologous serum incubated NK-92 cells for: AhR, IDO, KIR2DL1 and NKG2D. Differences were investigated using analysis-of-variance for acute and analysis-of-covariance for chronic effects. RESULTS: Acute exercise: IDO levels changed over time with a significant increase from post-CPET to 1 h post-CPET (p = 0.03). KIR2DL1 levels significantly decreased over time (p < 0.01). NKG2D levels remained constant (p = 0.31). Chronic exercise: for both IDO and NKG2D a significant group × time interaction, a significant time effect and a significant difference after 12 weeks of intervention were observed (IDO: all p < 0.01, NKG2D: all p > 0.05). CONCLUSION: Both acute and chronic endurance training may regulate NK cell function via the AhR/IDO axis. This is clinically relevant, as exercise emerges to be a key player in immune regulation.

Church Attendance and Mobility Limitation Among Black and White Men With Prostate Cancer.

Prostate cancer is a significant impediment that can reduce physical functional status. Mobility is fundamental for quality of life and church attendance to be associated with improved physical functioning. Few studies have examined how religious participation have implications for mobility limitation among men in general and among prostate cancer survivors in particular. The purpose of this study was to assess the association between church attendance and mobility limitation among Black and White prostate cancer patients and survivors. Data for this investigation were drawn from the Diagnosis and Decisions in Prostate Cancer Treatment Outcomes Study that consisted of 804 Black and White men with complete information on the primary outcome and predictor variables. Mobility limitation was the primary outcome variable, and church attendance was the main independent variable. The analytic sample was almost equally divided between Black (N = 382) and White men (N = 422). The proportion of Black men reporting mobility limitation (30.09%) more than doubled the corresponding percentage for White men (14.7%). Black men had a higher proportion of individuals who reported weekly church attendance (49.2% vs. 45.0%). Fully adjusted modified Poisson regression models produced results indicating that respondents attending church weekly had a lower mobility limitation prevalence (PR = 0.56, 95% CI [0.39, 0.81]) than those never attending church. Results from this study contribute to the body of evidence asserting the health benefits of church attendance. These findings suggest that health providers should consider how religion and spirituality can present opportunities for improved outcomes in prostate cancer patients and survivors.

Exercise modulation of tumour perfusion and hypoxia to improve radiotherapy response in prostate cancer.

BACKGROUND: An increasing number of studies indicate that exercise plays an important role in the overall care of prostate cancer (PCa) patients before, during and after treatment. Historically, research has focused on exercise as a modulator of physical function, psychosocial well-being as well as a countermeasure to cancer- and treatment-related adverse effects. However, recent studies reveal that exercise may also directly influence tumour physiology that could beneficially affect the response to radiotherapy. METHODS: In this narrative review, we provide an overview of tumour vascular characteristics that limit the effect of radiation and establish a rationale for exercise as adjunct therapy during PCa radiotherapy. Further, we summarise the existing literature on exercise as a modulator of tumour perfusion and hypoxia and outline potential future research directions. RESULTS: Preclinical research has shown that exercise can reduce intratumoral hypoxia-a major limiting factor in radiotherapy-by improving tumour perfusion and vascularisation. In addition, preliminary evidence suggests that exercise training can improve radiotherapy treatment outcomes by increasing natural killer cell infiltration in a murine PCa model. CONCLUSIONS: Exercise is a potentially promising adjunct therapy for men with PCa undergoing radiotherapy that may increase its effectiveness. However, exercise-induced tumour radiosensitisation remains to be confirmed in preclinical and clinical trials, as does the optimal exercise prescription to elicit such effects.

Resistance Exercise Dosage in Men with Prostate Cancer: Systematic Review, Meta-analysis, and Meta-regression.

PURPOSE: Resistance exercise improves an array of treatment-related adverse effects in men with prostate cancer; however, the minimal dosage required is unknown. We systematically reviewed the resistance training effects in prostate cancer patients to determine the minimal dosage regarding the exercise components (type, duration, volume, and intensity) on body composition, physical function, muscle strength, cardiorespiratory fitness, body mass index, and prostate-specific antigen. METHODS: Using PRISMA guidelines, MEDLINE, CINAHL, EMBASE, SPORTDiscus, and Web of Science databases were searched. Eligible randomized controlled trials examined prostate cancer patients undertaking resistance-based exercise programs during or after treatment. Meta-analysis was undertaken when more than three studies were included. Associations between mean differences and exercise components were tested by univariate and multivariate meta-regression analysis. RESULTS: Twenty-three articles describing 21 trials and involving 1748 prostate cancer patients were included. Exercise improved fat mass (-1% in body fat and -0.6 kg in fat mass), lean mass (~0.5 kg in lean and appendicular lean mass), functional capacity (i.e., chair rise, 400-m test, 6-m fast walk, and stair climb tests), and fitness outcomes (i.e., V̇O2peak and muscle strength) (P = 0.040-<0.001) with no change in body mass index or prostate-specific antigen (P = 0.440-0.735). Meta-regression indicated no association between exercise type, resistance training duration, weekly volume and intensity, and primary outcomes (P = 0.075-0.965). There was a significant association between exercise intensity and chest press muscle strength (favoring moderate intensity, P = 0.012), but not in other secondary outcomes. CONCLUSION: In untrained older men with prostate cancer initiating an exercise program, lower volume at moderate to high intensity is as effective as higher volume resistance training for enhancing body composition, functional capacity, and muscle strength in the short term. A low exercise dosage may help reduce barriers to exercise and enhance adherence.

The effect of exercise training on cardiometabolic health in men with prostate cancer receiving androgen deprivation therapy: a systematic review and meta-analysis.

BACKGROUND: Growing evidence suggests that men exposed to androgen deprivation therapy (ADT) have an increased risk of cardiovascular disease. While exercise has shown to attenuate some adverse effects of ADT, the effects on cardiometabolic health have not been systematically evaluated. OBJECTIVE: To evaluate the effect of exercise on cardiometabolic health in men with prostate cancer (PCa) receiving ADT. METHODS: A systematic literature search of MEDLINE, EMBASE, CINHAL, SCOPUS, WEB OF SCIENCE and SPORTSDICUS from database inception to April 2020 was performed. A quantitative synthesis using Cohens d effect size and a meta-analysis using random-effects models were conducted. RESULTS: Overall, fourteen randomised controlled trials (RCTs) and four non-randomised studies were included. Eleven RCTs (n = 939 patients) were included in the meta-analysis. Exercise training improved the 400-m-walk test (MD -10.11 s, 95% CI [-14.34, -5.88]; p < 0·00001), diastolic blood pressure (-2.22 mmHg, [-3.82, -0.61]; p = 0.007), fasting blood glucose (-0.38 mmol/L, [-0.65, -0.11]; p = 0.006), C-reactive protein (-1.16 mg/L, [-2.11, -0.20]; p = 0.02), whole-body lean mass (0.70 kg, [0.39, 1.01]; p < 0.0001), appendicular lean mass (0.59 kg, [0.43, 0.76]; p < 0.00001), whole-body fat mass (-0.67 kg, [-1.08, -0.27]; p = 0.001), whole-body fat percentage (-0.79%, [-1.16, -0.42]; p < 0.0001), and trunk fat mass (-0.49 kg, [-0.87, -0.12]; p = 0.01), compared to usual care. No significant effects on systolic blood pressure or blood lipid metabolism were detected. CONCLUSIONS: In a small subset of evaluated studies, exercise may favourably improve some but not all markers of cardiometabolic health. Future exercise intervention trials with cardiometabolic outcomes as primary endpoints are needed to confirm these initial findings.

Effects of high-intensity interval training compared with resistance training in prostate cancer patients undergoing radiotherapy: a randomized controlled trial.

BACKGROUND: Exercise training has shown beneficial effects in the management of radiotherapy-related side effects in prostate cancer (PCa) patients undergoing radiation therapy (RT). However, the optimal modality of the exercise programs have not been yet determined. The aim of this randomized controlled trial was to investigate the effects of high-intensity interval training (HIIT) and resistance training (RES) compared to usual care (UC) on cancer-treatment-related fatigue (CTRF) (primary outcome), quality of life, depression, daytime sleepiness, insomnia, sleep quality, functional exercise capacity and executive function in PCa patients during RT. METHODS: PCa patients undergoing RT with or without ADT were randomized in HIIT, RES or UC. Both exercise programs included three sessions per week during 5-8 weeks. HIIT consisted of 8-15 × 60 s intervals (≥85% maximal heart rate). RES was performed with 1-3 sets of 8-12 repetitions for each large muscle groups. The primary outcome was changed in CTRF measured with the Functional Assessment of Chronic Illness Therapy-Fatigue. RESULTS: Seventy-two subjects (69.1 ± 8.2 years) completed the study. No exercise-related adverse events occurred. HIIT (p = 0.012) and RES (p = 0.039) training attenuated increases in CTRF compared to UC. Functional exercise capacity, evaluated by the 6-min walk test, increased after HIIT (p = 0 = 0.43) and RES (p = 0.041) compared to UC (+0.1%). No other secondary variables were different between groups. CONCLUSIONS: Both intervention groups displayed beneficial effects on CTRF and functional exercise capacity in PCa patients undergoing RT. In addition, HIIT and RES are both safe with an excellent attendance rate to the exercise sessions.

Prostate Cancer-based Interventions' Efficacy on Knowledge and Adherence Intention to Healthy Lifestyle among Men.

BACKGROUND: Previous Literature has supported educational program efficacy, but no studies have been found to examine Prostate Cancer-based interventions' Efficacy on knowledge and adherence intention to a healthy lifestyle among Men in Jordan. PURPOSE: The purpose of the current study was to assess Prostate Cancer-based interventions' efficacy on knowledge and adherence intention to a healthy lifestyle among Men in Jordan. METHODS: A quasi-experimental research with one group pretest-posttest design was used and the study was conducted in Masjids (praying place), Amman, Jordan. The population consists of Jordanian Men aged 40 years and above. The sample size was 76 men, who fulfilled the inclusion criteria. The tool used for data collection was a structured questionnaire. RESULTS: Paired sample t-test showed that the change in the mean knowledge scores (9.5), p < .001 was statistically significant 1 month after the application of the program. In addition, the change in the mean adherence to healthy lifestyle scores (4.7), p < .05 was statistically significant 1 month after the application of the structured teaching program. CONCLUSION: Jordanian men had gained knowledge and Adherence Intention to Healthy Lifestyle regarding prostate cancer after the implementation of a structured teaching program. IMPLICATIONS FOR PRACTICE: Educational program aimed at motivating men to increase their knowledge of prostate cancer and having adherence intention to a healthy lifestyle.
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Race differences in mobility status among prostate cancer survivors: The role of socioeconomic status.

The objective of this paper was to determine whether there were any race differences in mobility limitation among PCa survivors, and understand the impact of socioeconomic status (SES) on this relationship. Data consisted of 661 PCa survivors (296 Black and 365 White) from the Diagnosis and Decisions in Prostate Cancer Treatment Outcomes (DAD) Study. Mobility limitation was defined as PCa survivors who reported difficulty walking a quarter mile or up 1 flight of stairs. Race was based on the PCa survivors self-identification of either White or Black. SES consisted of education level (i.e., less than high school, high school/GED, some college/associate, bachelors, masters/PhD) and annual household income (i.e., less than $50,000; $50,000-$100,000; greater than $100,000). Adjusting for age, marital status, health insurance, Gleason Score, treatment received, and time to treatment, Black PCa survivors had a higher prevalence of mobility limitation (PR=1.58, 95% CI: 1.17-2.15) relative to White PCa survivors. When adding education and income to the adjusted model, Black PCa survivors had a similar prevalence of mobility limitation (PR=1.12, 95% CI: 0.80-1.56) as White PCa survivors. The unequal distribution of SES resources between Black and White PCa survivors accounted for the observed race differences in mobility limitation. This work emphasizes the importance of SES in understanding race differences in mobility among PCa survivors.

Exercise intensity prescription in cancer survivors: ventilatory and lactate thresholds are useful submaximal alternatives to VO2peak.

PURPOSE: Most studies with cancer survivors use percentages of peak oxygen uptake (VO2peak) for intensity prescription. Lactate or ventilatory thresholds might be useful submaximal alternatives, but this has never been investigated. Therefore, we aimed at comparing three training sessions prescribed using %VO2peak (reference), lactate thresholds, and ventilatory thresholds in terms of meeting the vigorous-intensity zone, physiological, and psychological responses. METHODS: Twenty breast (58 ± 10 years) and 20 prostate cancer survivors (68 ± 6 years), 3.6 ± 2.4 months after primary therapy, completed a maximal cardiopulmonary exercise test and three vigorous training sessions in randomized order: 38 min of cycling at 70% VO2peak (M-VO2peak), 97% of individual anaerobic lactate threshold (M-IAT), and 67% between ventilatory thresholds 1 and 2 (M-VT). Heart rate (HR), blood lactate concentration (bLa), perceived exertion, and enjoyment were assessed. RESULTS: Cancer survivors exercised at 75 ± 23, 85 ± 18, and 79 ± 19 W during M-VO2peak, M-IAT, and M-VT (p > .05). Sessions could not be completed in 3, 8, and 6 cases. Session completers showed HR of 82 ± 7, 83 ± 9, and 84 ± 8 %HRpeak and bLa of 3.7 ± 1.9, 3.9 ± 0.9, and 3.9 ± 1.5 mmol·l-1, which was not different between sessions (p > .05). However, variance in bLa was lower in M-IAT compared to M-VO2peak (p = .001) and to M-VT (p = .022). CONCLUSION: All intensity prescription methods on average met the targeted intensity zone. Metabolic response was most homogeneous when using lactate thresholds. IMPLICATIONS FOR CANCER SURVIVORS: Submaximal thresholds are at least as useful as VO2peak for intensity prescription in cancer survivors. Overall, slightly lower percentages should be chosen to improve durability of the training sessions.

Rural cancer survivors' health information needs post-treatment.

OBJECTIVE: This study describes the most common cancer-related health information needs among rural cancer survivors and characteristics associated with reporting more information needs. METHODS: Rural breast, prostate, and colorectal cancer survivors, two to five years post-diagnosis, identified from an institutional cancer registry, completed a mailed/telephone-administered survey. Respondents were asked about 23 health information needs in eight domains (tests and treatment, side effects and symptoms, health promotion, fertility, interpersonal, occupational, emotional, and insurance). Poisson regression models were used to assess relationships between number of health information needs and demographic and cancer characteristics. RESULTS: Participants (n = 170) reported an average of four health information needs, with the most common domains being: side effects and symptoms (58 %), health promotion (54 %), and tests and treatment (41 %). Participants who were younger (compared to 5-year increase, rate ratio [RR] = 1.11, 95 % CI = 1.02-1.21), ethnic minority (RR = 1.89, 95 % CI = 1.17-3.06), less educated (RR = 1.49, 95 % CI = 1.00-2.23), and financially stressed (RR = 1.87, 95 % CI = 1.25-2.81) had a greater number of information needs. CONCLUSIONS: Younger, ethnic minority, less educated, and financially strained rural survivors have the greatest need for informational support. PRACTICE IMPLICATIONS: The provision of health information for rural cancer survivors should consider type of cancer, treatments received, and sociocultural differences to tailor information provided.

Effects of exercise interventions on social and cognitive functioning of men with prostate cancer: a meta-analysis.

PURPOSE: Exercise is beneficial for prostate cancer patients' physical functioning; however, effects on social and cognitive functioning are inconsistent. This meta-analysis of exercise interventions for prostate cancer patients had two aims: the primary aim was to evaluate the effects of exercise interventions on social functioning; the secondary aim was to consider additional outcomes of cognitive functioning as well as adverse events. METHODS: Electronic databases (Embase, MEDLINE, PubMed, PsycINFO, and the Chinese database Airti Library) were searched for relevant papers (1987-2019), which included hand searching. After careful inspection, 10 relevant randomized controlled trials were analyzed using Comprehensive Meta-Analysis software; pooled means determined social and cognitive functioning. RESULTS: Meta-analysis of summary scores (fixed-effects model) showed an overall beneficial effect of exercise on social functioning (Hedges' g = 0.35, 95% CI [0.193, 0.515], p < 0.001) and cognitive functioning (Hedges' g = 0.35, 95% CI [0.123, 0.575], p < 0.01) in men with prostate cancer when compared to controls. Intervention durations of 12-16 and 24-48 weeks that provided supervised aerobic exercise combined with resistance exercise sessions had a small to medium effect on social functioning compared to controls. One exercise group experienced one serious, but non-fatal, adverse event due to a higher exercise intensity (50-75% VO2max). DISCUSSION AND RECOMMENDATIONS: To the best of our knowledge, this is the first meta-analysis to examine the effects of exercise interventions on cognitive functioning among prostate cancer patients. We suggest further research be conducted to confirm these findings.

Behaviour change techniques in physical activity interventions for men with prostate cancer: A systematic review.

Physical activity interventions can improve prostate cancer survivors' health. Determining the behaviour change techniques used in physical activity interventions can help elucidate the mechanisms by which an intervention successfully changes behaviour. The purpose of this systematic review was to identify and evaluate behaviour change techniques in physical activity interventions for prostate cancer survivors. A total of 7 databases were searched and 15 studies were retained. The studies included a mean 6.87 behaviour change techniques (range = 3-10), and similar behaviour change techniques were implemented in all studies. Consideration of how behaviour change techniques are implemented may help identify how behaviour change techniques enhance physical activity interventions for prostate cancer survivors.

Identifying Expectations of Delayed Return to Work in Patients with Prostate Cancer at the Beginning of a Cancer Rehabilitation Program.

Purpose To investigate factors associated with expectations of delayed return to work (RTW) in patients with prostate cancer recently admitted to a cancer rehabilitation program. Methods In this multicenter study, data about expected time until RTW and potential correlates (personal, medical, psychosocial and work-related factors) were obtained from 822 employed cancer rehabilitation participants at the beginning of the program. Participants expecting early RTW (≤ 3 months) and delayed RTW (> 3 months) were compared. Hierarchical multivariate logistic regression was applied to study which factors are associated with expecting delayed RTW. Results In total, 171 cancer rehabilitation participants (21%) expected delayed RTW. Group comparison showed education, type of occupation, income, number of comorbid conditions, tumor stage according to the staging system of the Union for International Cancer Control (UICC), anxiety and depression, quality-of-life functioning scales, urinary and treatment-related symptoms, duration of sick leave, subjective work ability, perceived ability to return to the former job, intention to apply for a disability pension, effort-reward-imbalance and occupational stress to be associated in bivariate analysis with participants' expectations. Multivariate analysis revealed UICC tumor stage III (compared to stages I/II, OR 2.36), lower subjective work ability (OR 0.82), perceived inability to return to the former job (OR 1.88) and intention to apply for a disability pension (OR 1.94) to increase the likelihood of expecting delayed RTW. Conclusions Negative or non-beneficial RTW expectations, which are related to self-perception and behavioral intention, seem to be key factors for expecting delayed RTW. Interventions to early identify and adjust such expectations might empower cancer rehabilitation participants to develop appropriate expectations for work recovery.

Assessing the effect of patient navigator assistance for psychosocial support services on health-related quality of life in a randomized clinical trial in Latino breast, prostate, and colorectal cancer survivors.

BACKGROUND: After a diagnosis of prostate, breast, or colorectal cancer, Latinos experience higher mortality rates and lower health-related quality of life (HRQOL) in comparison with other ethnic/racial groups. Patient navigation (PN) and lay community health workers or promotores are effective in increasing cancer screening and early-stage diagnosis among Latinos. However, little is known about the effect of PN on HRQOL among Latino cancer survivors. METHODS: Latinos previously diagnosed with breast, prostate, or colorectal cancer (n = 288) were randomized to 1 of 2 conditions: 1) the Patient Navigator LIVESTRONG Cancer Navigation Services (PN-LCNS) survivor care program or 2) PN only. HRQOL was measured with the Functional Assessment of Cancer Therapy-General, and cancer-specific HRQOL was measured with the Functional Assessment of Cancer Therapy-Breast, the Functional Assessment of Cancer Therapy-Prostate, and the Functional Assessment of Cancer Therapy-Colorectal for breast, prostate, and colorectal cancer survivors, respectively, at the baseline and at 3 follow-up time points. Generalized estimating equation analyses were conducted to estimate the effect of condition on HRQOL with adjustments for covariates and baseline HRQOL. RESULTS: PN-LCNS demonstrated a significant improvement in HRQOL in comparison with PN only for colorectal cancer survivors but not for breast and prostate cancer survivors. CONCLUSIONS: Enhanced PN improves HRQOL among Latino colorectal cancer survivors. Future research should identify the best strategies for engaging Latino survivors in PN programs. PN programs should also be adapted to address HRQOL concerns among Latina breast cancer survivors.

Exploring health behaviors, quality of life, and support needs in African-American prostate cancer survivors: a pilot study to support future interventions.

PURPOSE: Prostate cancer incidence and mortality rates are highest among African-American men. Comorbidity burden and quality of life (QOL) challenges are also high. Many factors drive these differences; health behaviors are important modifiable contributors. Studies document positive results for lifestyle interventions targeting NHW prostate cancer survivors, but inclusion of African-Americans is limited. We conducted an exploratory mixed-methods study with AAPCS to inform the development of a culturally relevant lifestyle intervention. METHODS: Twenty-two AAPCS completed questionnaires and a discussion group on dietary and physical activity patterns, QOL, and unmet needs related to lifestyle changes. RESULTS: Seventy-five percent of the participants were overweight or obese, 82% had physical activity patterns considered insufficiently active and only 10% did resistance training at least twice weekly in accordance with current survivorship guidelines. Diets were high in saturated fat and sugar, low in fiber, fruit, and vegetable intake. PROMIS-29 scores indicated that AAPCS had worse physical functioning, pain interference, and sexual functioning, but less social isolation compared to the general population. Compared to other prostate cancer survivors, participants reported poorer status on all domains. Qualitative data highlighted barriers to healthy lifestyles including access, knowledge, and skills, as well as motivators including health benefits and building strength to feel more "manly." Participants shared high interest in programs to exercise, learn about affordable healthy eating, and bring survivors together to discuss survivorship issues. CONCLUSIONS: Lifestyle interventions targeting AAPCS are warranted. To increase impact of these efforts, consideration of environmental, cultural, and survivor contexts will be key.

Phase II randomised control feasibility trial of a nutrition and physical activity intervention after radical prostatectomy for prostate cancer.

OBJECTIVE: Dietary factors and physical activity may alter prostate cancer progression. We explored the feasibility of lifestyle interventions following radical prostatectomy for localised prostate cancer. DESIGN: Patients were recruited into a presurgical observational cohort; following radical prostatectomy, they were offered randomisation into a 2×3 factorial randomised controlled trial (RCT). SETTING: A single National Health Service trust in the South West of England, UK. PARTICIPANTS: Those with localised prostate cancer and listed for radical prostatectomy were invited to participate. RANDOMISATION: Random allocation was performed by the Bristol Randomised Trial Collaboration via an online system. INTERVENTIONS: Men were randomised into both a modified nutrition group (either increased vegetable and fruit, and reduced dairy milk; or lycopene supplementation; or control) and a physical activity group (brisk walking or control) for 6 months. BLINDING: Only the trial statistician was blind to allocations. PRIMARY OUTCOME MEASURES: Primary outcomes were measures of feasibility: randomisation rates and intervention adherence at 6 months. Collected at trial baseline, three and six months, with daily adherence reported throughout. Our intended adherence rate was 75% or above, the threshold for acceptable adherence was 90%. RESULTS: 108 men entered the presurgical cohort, and 81 were randomised into the postsurgical RCT (randomisation rate: 93.1%) and 75 completed the trial. Of 25 men in the nutrition intervention, 10 (40.0%; 95% CI 23.4% to 59.3%) adhered to the fruit and vegetable recommendations and 18 (72.0%; 95% CI 52.4% to 85.7%) to reduced dairy intake. Adherence to lycopene (n=28), was 78.6% (95% CI 60.5% to 89.8%), while 21/39 adhered to the walking intervention (53.8%; 95% CI 38.6% to 68.4%). Most men were followed up at 6 months (75/81; 92.6%). Three 'possibly related' adverse events were indigestion, abdominal bloating and knee pain. CONCLUSIONS: Interventions were deemed feasible, with high randomisation rates and generally good adherence. A definitive RCT is proposed. TRIAL REGISTRATION NUMBER: ISRCTN 99048944.