Prostate cancer-Exercise and Metformin Trial (Pre-EMpT): study protocol for a feasibility factorial randomized controlled trial in men with localised or locally advanced prostate cancer.

BACKGROUND: Evidence from observational studies have shown that moderate intensity physical activity can reduce risk of progression and cancer-specific mortality in participants with prostate cancer. Epidemiological studies have also shown participants taking metformin to have a reduced risk of prostate cancer. However, data from randomised controlled trials supporting the use of these interventions are limited. The Prostate cancer-Exercise and Metformin Trial examines that feasibility of randomising participants diagnosed with localised or locally advanced prostate cancer to interventions that modify physical activity and blood glucose levels. The primary outcomes are randomisation rates and adherence to the interventions over 6 months. The secondary outcomes include intervention tolerability and retention rates, measures of insulin-like growth factor I, prostate-specific antigen, physical activity, symptom-reporting, and quality of life. METHODS: Participants are randomised in a 2 × 2 factorial design to both a physical activity (brisk walking or control) and a pharmacological (metformin or control) intervention. Participants perform the interventions for 6 months with final measures collected at 12 months follow-up. DISCUSSION: Our trial will determine whether participants diagnosed with localised or locally advanced prostate cancer, who are scheduled for radical treatments or being monitored for signs of cancer progression, can be randomised to a 6 months physical activity and metformin intervention. The findings from our trial will inform a larger trial powered to examine the clinical benefits of these interventions. TRIAL REGISTRATION: Prostate Cancer Exercise and Metformin Trial (Pre-EMpT) is registered on the ISRCTN registry, reference number ISRCTN13543667 . Date of registration 2nd August 2018-retrospectively registered. First participant was recruited on 11th September 2018.

Attitudes and adherence to changes in nutrition and physical activity following surgery for prostate cancer: a qualitative study.

OBJECTIVES: Interventions designed to improve men's diet and physical activity (PA) have been recommended as methods of cancer prevention. However, little is known about specific factors that support men's adherence to these health behaviour changes, which could inform theory-led diet and PA interventions. We aimed to explore these factors in men following prostatectomy for prostate cancer (PCa). DESIGN, SETTING AND PARTICIPANTS: A qualitative study using semistructured interviews with men, who made changes to their diet and/or PA as part of a factorial randomised controlled trial conducted at a single hospital in South West England. Participants were 17 men aged 66 years, diagnosed with localised PCa and underwent prostatectomy. Interview transcripts underwent thematic analysis. RESULTS: Men were ambivalent about the relationship of nutrition and PA with PCa risk. They believed their diet and level of PA were reasonable before being randomised to their interventions. Men identified several barriers and facilitators to performing these new behaviours. Barriers included tolerance to dietary changes, PA limitations and external obstacles. Facilitators included partner involvement in diet, habit formation and brisk walking as an individual activity. Men discussed positive effects associated with brisk walking, such as feeling healthier, but not with nutrition interventions. CONCLUSIONS: The facilitators to behaviour change suggest that adherence to trial interventions can be supported using well-established behaviour change models. Future studies may benefit from theory-based interventions to support adherence to diet and PA behaviour changes in men diagnosed with PCa.

Dietary management for people with an ileostomy: a scoping review.

OBJECTIVE: The objective of this review was to identify and map the evidence for oral dietary management of ileostomies. INTRODUCTION: Dietary advice is commonly provided for ileostomy management but can be inconsistent, conflicting, and inadequate. There is a lack of high-quality research investigating dietary management of ileostomies. This scoping review highlights gaps in the literature that need addressing to inform practice, and identifies dietary strategies and outcomes to be investigated in future studies. INCLUSION CRITERIA: Evidence relating to the use of oral dietary strategies to manage complications and nutritional consequences associated with having an ileostomy was included. Evidence included all types of original research (ie, quantitative and qualitative methodologies, expert opinion articles, and consensus guidelines). METHODS: This review followed JBI methodology for scoping reviews. A pre-determined search of 13 databases, including MEDLINE, Embase, and Web of Science, was conducted in August 2019. The search was not limited by date, but during screening, expert opinion evidence was limited to 2008 onward. Data extraction was carried out by two reviewers for each study/article using a database tool designed specifically for this review. Results are presented using a combination of tabular summaries and narrative reports. RESULTS: Thirty-one research studies were included: 11 experimental (including four crossover randomized controlled trials), three pre-post design, 13 observational (12 cross-sectional, one longitudinal), and four qualitative. Forty-four expert opinion articles/guidelines were also included. In experimental studies, nine nutrient modifications and 34 individual foods/drinks were investigated. In pre-post studies, 10 nutrient modifications, 80 foods/drinks, and 11 eating-related behaviors were investigated. In observational studies, eight nutrient modifications, 94 foods/drinks, and five eating-related behaviors were reported. In qualitative studies, two nutrient modifications, 17 foods/drinks, and one eating-related behavior were reported. In expert opinion articles/guidelines, recommendations relating to 51 nutrient modifications, 339 foods/drinks, and 23 eating-related behaviors were reported. Although large numbers of individual foods and drinks were suggested to be associated with outcomes relating to ileostomy management, findings from observational studies showed these were generally reported by <50% of people with an ileostomy. The most common nutrients reported in association with outcomes related to ileostomy management were fiber, fat, and alcohol. Across most outcomes and studies/expert opinion, low fiber and low fat were suggested to be beneficial, while alcohol was detrimental. Other nutrient associations frequently reported in expert opinion (but with minimal attention in research studies) included negative consequences of caffeinated drinks and positive effects of white starchy carbohydrates on stoma output. Output volume and consistency were the most commonly reported outcomes relating to ileostomy management across all study types. Flatulence and odor were also common outcomes in observational studies. CONCLUSIONS: This review found an abundance of literature, particularly expert opinion, reporting on dietary management for people with an ileostomy. However, this literature was highly heterogeneous in terms of dietary strategies and outcomes reported. It is likely that most dietary advice provided in practice is based on expert opinion with some supported by limited research. High-quality research investigating the effect of the dietary strategies identified in this review on commonly associated outcomes relating to ileostomy management is needed to improve evidence-based advice.

Prostate cancer survivors' preferences on the delivery of diet and lifestyle advice: a pilot best-worst discrete choice experiment.

BACKGROUND: Lifestyle factors, including diet and physical activity, are associated with prostate cancer progression and mortality. However, it is unclear how men would like lifestyle information to be delivered following primary treatment. This study aimed to identify men's preferences for receiving lifestyle information. METHODS: We conducted a cross-sectional pilot best-worst discrete choice experiment which was nested within a feasibility randomised controlled trial. Our aim was to explore men's preferences of receiving diet and physical activity advice following surgery for localised prostate cancer. Thirty-eight men with a mean age of 65 years completed best-worst scenarios based on four attributes: (1) how information is provided; (2) where information is provided; (3) who provides information; and (4) the indirect cost of receiving information. Data was analysed using conditional logistic regression. Men's willingness to pay (WTP) for aspects of the service was calculated using an out-of-pocket cost attribute. RESULTS: The combined best-worst analysis suggested that men preferred information through one-to-one discussion ß = 1.07, CI = 0.88 to 1.26) and not by email (ß = - 1.02, CI = - 1.23 to - 0.80). They preferred information provided by specialist nurses followed by dietitians (ß = 0.76, CI = 0.63 to 0.90 and - 0.16, CI = - 0.27 to - 0.05 respectively) then general nurses (ß = - 0.60, CI = - 0.73 to - 0.48). Three groups were identified based on their preferences. The largest group preferred information through individual face-to-face or group discussions (ß = 1.35, CI = 1.05 to 1.63 and 0.70, CI = 0.38 to 1.03 respectively). The second group wanted information via one-to-one discussions or telephone calls (ß = 1.89, CI = 1.41 to 2.37 and 1.03, CI = 0.58 to 1.48 respectively), and did not want information at community centres (ß = - 0.50, CI = - 0.88 to - 0.13). The final group preferred individual face-to-face discussions (ß = 0.45, CI = 0.03 to 0.88) but had a lower WTP value (£17). CONCLUSIONS: Men mostly valued personalised methods of receiving diet and physical activity information over impersonal methods. The out-of-pocket value of receiving lifestyle information was important to some men. These findings could help inform future interventions using tailored dietary and physical activity advice given to men by clinicians following treatment for prostate cancer, such as mode of delivery, context, and person delivering the intervention. Future studies should consider using discrete choice experiments to examine information delivery to cancer survivor populations.

A feasibility randomised controlled trial of short-term fasting prior to CAPOX chemotherapy for stage 2/3 colorectal cancer: SWiFT protocol.

BACKGROUND: Capecitabine and oxaliplatin (CAPOX) chemotherapy is a standard treatment for stage 2/3 colorectal cancer. Treatment is associated with dose-limiting toxicities such as neutropenia, vomiting, diarrhoea, and stomatitis. Short-term fasting prior to chemotherapy may help protect normal cells from the toxic effects of chemotherapy by allowing them to conserve energy for maintenance and repair. However, there is a lack of evidence to support the efficacy of short-term fasting in protecting against chemotherapy-related toxicities in humans, and it is not known whether people due to undergo chemotherapy will be willing and able to follow a short-term fast. Preliminary data confirming this is feasible are required before adequately powered trials can be designed and conducted. METHODS: The short-term, water only, fasting trial (SWiFT) is a two-armed feasibility randomised controlled trial, aiming to recruit 30 people scheduled to begin routine treatment with CAPOX chemotherapy for stage 2/3 colorectal cancer. Participants will be randomly allocated, in a 1:1 ratio, to either a 36-h fast or standard dietary advice prior to chemotherapy administration for the first 3 cycles of chemotherapy. The primary outcome measures will assess the feasibility of the trial and include: adherence to intervention, recruitment, retention, and data completion rates as well as the acceptability of the intervention which will be qualitatively assessed. The secondary outcome measures aim to provide further information on possible outcomes of interest for a definitive trial and include side effects of chemotherapy, quality of life, markers of cellular metabolism and inflammation, appetite, and sarcopenia. DISCUSSION: It is not known whether it is possible to recruit to a trial of short-term fasting in this population, or whether participants would be able to adhere to the intervention. Therefore, we aim to test the feasibility of a pre-chemotherapy, 36-h, water-only fast in people receiving CAPOX chemotherapy for stage 2/3 colorectal cancer. TRIAL REGISTRATION: This trial has been registered with the ISRCTN Registry. Trial registration no: ISRCTN17994717. Date of registration: 23 October 2018. URL: http://www.isrctn.com/ISRCTN17994717.

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.

Dietary restriction during the treatment of cancer: results of a systematic scoping review.

BACKGROUND: Diets that restrict energy or macronutrient intake (e.g. fasting/ketogenic diets (KDs)) may selectively protect non-tumour cells during cancer treatment. Previous reviews have focused on a subset of dietary restrictions (DR) or have not performed systematic searches. We conducted a systematic scoping review of DR at the time of cancer treatment. METHODS: MEDLINE, Embase, CINAHL, AMED and Web of Science databases were searched for studies of adults undergoing DR alongside treatment for cancer. Search results were screened against inclusion/exclusion criteria. Data from included studies were extracted by two independent reviewers. Results were summarised narratively. RESULTS: Twenty-three independent studies (34 articles), with small sample sizes, met the inclusion criteria. Four categories were identified: KDs (10 studies), fasting (4 studies), protein restriction (5 studies) and combined interventions (4 studies). Diets were tolerated well, however adherence was variable, particularly for KDs. Biomarker analysis in KDs and fasting resulted in the expected increase in ketones or reduction in insulin-like growth factors, respectively, however they did not reduce glucose. CONCLUSIONS: Future research with adequately powered studies is required to test the effects of each DR intervention on treatment toxicities and outcomes. Further research into improving adherence to DR may improve the feasibility of larger trials.

Systematic review evaluating randomized controlled trials of smoking and alcohol cessation interventions in people with head and neck cancer and oral dysplasia.

BACKGROUND: Smoking and alcohol increase the risk of head and neck cancer and affect treatment outcomes. Interventions modifying these behaviors may improve posttreatment outcomes and survival. We systematically reviewed evidence of the effectiveness of smoking/alcohol interventions in head and neck cancer and oral dysplasia. METHODS: The AMED, CINAHL, Embase, MEDLINE, and Web of Science databases were searched for randomized controlled trials (RCTs) of smoking/alcohol interventions in people with head and neck cancer. A qualitative synthesis of the studies was conducted. RESULTS: Three RCTs were identified: 2 smoking interventions and 1 smoking and alcohol intervention. One intervention, which was comprised of a smoking intervention based on Cognitive Behavioral Therapy and pharmacologic management compared to usual care, reduced smoking prevalence. CONCLUSION: Further research is required into the underlying mechanisms that lead to cessation and interventions that include both pharmacological and behavioral therapy. Future RCTs should include suitable control conditions and sufficient power to assess clinical outcomes.

Tobacco and alcohol cessation or reduction interventions in people with oral dysplasia and head and neck cancer: systematic review protocol.

BACKGROUND: Head and neck cancers include malignancies of the mouth, larynx and oropharynx. Tobacco use and alcohol consumption are associated with increased risks of developing and dying from head and neck cancer. The aim of this review is to examine the effectiveness of smoking and alcohol cessation interventions on disease-related outcomes, quality of life and behavioural change in adults with head and neck cancer and oral dysplasia. METHODS: The Cochrane library, CINAHL, Embase, MEDLINE, PsycINFO and Web of Science databases will be searched for randomised controlled trials investigating the effects of smoking or alcohol interventions on patients with either head and neck cancer or oral dysplasia. The primary outcomes are disease-free survival and, for participants with oral dysplasia, malignant transformation to cancer. Secondary outcomes are disease recurrence and progression, quality of life and behavioural change. The quality of included studies will be assessed using the 'Cochrane Collaborations tool for assessing risk of bias'. A qualitative synthesis of the results will be reported, and a meta-analysis of the outcome data conducted, where appropriate. DISCUSSION: This systematic review will identify the extent of the current research on smoking and alcohol cessation interventions in patients with head and neck cancer and oral epithelial dysplasia. The findings have the potential to inform which interventions have been successful and how future behavioural change interventions should be conducted within these populations. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016038237.

The feasibility of the Prostate cancer: Evidence of Exercise and Nutrition Trial (PrEvENT) dietary and physical activity modifications: a qualitative study.

BACKGROUND: There is increasing evidence that low levels of physical activity and diets low in fruit and vegetables and high in meat and dairy products are risk factors for prostate cancer disease progression. The Prostate cancer: Evidence of Exercise and Nutrition Trial (PrEvENT) aimed to assess a diet and physical activity intervention in men undergoing radical prostatectomy for localized prostate cancer. The trial included a qualitative component to explore the experiences of men participating in the trial in order to understand the acceptability of the intervention and data collection methods. We report the qualitative findings of the trial and consider how these can be used to inform future research. METHODS: PrEvENT involved randomizing men to either a dietary and/or physical activity intervention. Semi-structured interviews were conducted with a purposive sample of 17 men on completion of the 6 month trial. Interviews took place in clinic or as telephone interviews, if requested by the participant, and were audio recorded, transcribed, and analyzed using the thematic-based framework approach. Analysis was conducted throughout the data collection process to allow emergent themes to be further explored in subsequent interviews. RESULTS: Three overarching themes were identified: acceptability of the intervention, acceptability of the data collection methods and trial logistics. Participants were predominantly positive about both the dietary and physical activity interventions and most men found the methods of data collection appropriate. Recommendations for future trials include consideration of alternative physical activity options, such as cycling or gym sessions, increased information on portion sizes, the potential importance of including wives or partners in the dietary change process and the possibility of using the pedometer or other wearable technology as part of the physical activity intervention. CONCLUSIONS: We provide insight into the opinions and experiences of the acceptability of the PrEvENT diet and physical activity intervention from the participants themselves. The interventions delivered were acceptable to this sample of participants, as were the data collection methods utilized. We also highlight some considerations for further behavioural change interventions in prostate cancer and other similar populations. TRIAL REGISTRATION: ISRCTN, ISRCTN99048944 . Registered on 17 November 2014.