Randomized Trial to Assess the Impact of Venlafaxine and Soy Protein on Hot Flashes and Quality of Life in Men With Prostate Cancer

Vitolins, Mara Z.; Griffin, Leah; Tomlinson, W. Vic; Vuky, Jacqueline; Adams, Paul; Moose, Dawn; Frizzell, Bart; Lesser, Glenn J.; Naughton, M.J.; Radford, James E.; Shaw, Edward G.

doi:10.1200/jco.2012.48.1432

Cited by 38 publications

(38 citation statements)

References 19 publications

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“…Two dietary RCTs of 99 participants investigated the efficacy of 12 weeks of soy supplementation on QoL, androgen deprivation symptoms or metabolic risk factors in men with PCa (Sharma et al 2009, Napora et al 2011, Vitolins et al 2013. One study had four treatment groups randomising venlafaxine and venlafaxine placebo as well as soy and soy placebo (Vitolins et al 2013).…”

Section: Interventionsmentioning

confidence: 99%

See 1 more Smart Citation

Exercise improves quality of life in androgen deprivation therapy-treated prostate cancer: systematic review of randomised controlled trials

Teleni¹,

Chan²,

Chan³

et al. 2015

Endocrine-Related Cancer

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Men receiving androgen deprivation therapy (ADT) for prostate cancer (PCa) are likely to develop metabolic conditions such as diabetes, cardiovascular disease, abdominal obesity and osteoporosis. Other treatment-related side effects adversely influence quality of life (QoL) including vasomotor distress, depression, anxiety, mood swings, poor sleep quality and compromised sexual function. The objective of this study was to systematically review the nature and effects of dietary and exercise interventions on QoL, androgen deprivation symptoms and metabolic risk factors in men with PCa undergoing ADT. An electronic search of CINAHL, CENTRAL, Medline, PsychINFO and reference lists was performed to identify peerreviewed articles published between January 2004 and December 2014 in English. Eligible study designs included randomised controlled trials (RCTs) with pre-and post-intervention data. Data extraction and assessment of methodological quality with the Cochrane approach was conducted by two independent reviewers. Seven exercise studies were identified. Exercise significantly improved QoL, but showed no effect on metabolic risk factors (weight, waist circumference, lean or fat mass, blood pressure and lipid profile). Two dietary studies were identified, both of which tested soy supplements. Soy supplementation did not improve any outcomes. No dietary counselling studies were identified. No studies evaluated androgen-deficiency symptoms (libido, erectile function, sleep quality, mood swings, depression, anxiety and bone mineral density). Evidence from RCTs indicates that exercise

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Section: Interventionsmentioning

confidence: 99%

“…One study had four treatment groups randomising venlafaxine and venlafaxine placebo as well as soy and soy placebo (Vitolins et al 2013). For this review, we only included the treatment groups where venlafaxine placebos were used so as to compare the effects of soy supplementation.…”

Section: Interventionsmentioning

confidence: 99%

Exercise improves quality of life in androgen deprivation therapy-treated prostate cancer: systematic review of randomised controlled trials

Teleni¹,

Chan²,

Chan³

et al. 2015

Endocrine-Related Cancer

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“…These data should be regarded as preliminary only, given the small sample (n=36). Some support for soy supplementation in the diet of men on ADT has been reported by Vitolins and colleagues [53] in a trial evaluating soy protein supplementation (20 g with 160 mg isoflavones, n = 30), versus Venlafaxine (75mg once daily, n =30), versus combined soy and Venlafaxine (n =30) or milk powder placebo (n =30). The authors reported a significant and clinically relevant difference in FACT-P after 12 weeks in men taking soy protein (mean = 113 points, SE = 6 points) versus men who did not take soy protein (mean = 104 points, SE = 6 points).…”

Section: Dietmentioning

confidence: 99%

Survivorship and Improving Quality of Life in Men with Prostate Cancer

et al. 2015

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“…sachet of powder [soy isoflavones or placebo] and single tablet [venlafaxine or placebo]) had a compliance rate of 92% [366] . While this trial aimed to ameliorate ADT-induced hot flushes, the high compliance observed supports our findings that a powder sachet and single tablet appears to be a feasible approach for administering a multi-nutrient supplement in these men.…”

Section: Attrition and Adherencementioning

confidence: 99%

Muscle, fat and performance during androgen deprivation for prostate cancer

Owen¹

2018

Preprint

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Introduction: Prostate cancer (PCa) is one of the most frequently diagnosed male cancers worldwide. One treatment, androgen deprivation therapy (ADT), is often accompanied with a myriad of adverse effects, including those that negatively impact muscle, fat and performance outcomes. Therefore, ADT-treated men may be living longer, but are at risk of both age- and treatment-related complications. The overall aim of this thesis was to quantify outcomes of muscle, fat and performance in men treated with ADT when compared to PCa (men diagnosed with PCa, not treated with ADT) and healthy controls (men not diagnosed with PCa), and assess the feasibility of implementing a multi-component exercise program combined with protein, calcium and vitamin D supplementation (Ex+ProCaD) compared to usual care in ADT-treated men. Methods: This thesis presents two studies that form part of a larger 52-week randomised controlled trial (RCT), which examined the efficacy of Ex+ProCaD compared to usual care in men treated with ADT for PCa. The first study presented was a nested cross-sectional study performed parallel to the baseline assessment of the RCT and examined differences in muscle, fat and performance outcomes between men treated with ADT when compared to PCa and healthy controls. The second study presented examined the feasibility of implementing the first 26 weeks of the RCT. Results: The cross-sectional study showed that height, weight, body mass index and diet were similar between the three groups, but ADT-treated men were four years older and tended to be less physically active (23-30%; P=0.054). After adjusting for age and physical activity, total body fat mass was 3.3-5.0 kg (P < 0.05) greater in men treated with ADT compared to PCa controls, but there was no difference in total body and regional lean mass. When adiposity was considered, ADT-treated men had 10-12% (P < 0.05) lower appendicular lean mass adjusted for body mass index and 5.6-6.4% (P < 0.05) lower forearm percent muscle cross-sectional area compared to controls. Absolute muscle strength was similar between groups, but when expressed relative to body weight, men treated with ADT had 13-21% (P < 0.05) lower muscle strength compared to controls. Whilst only two ADT-treated men had sarcopenia, these men had a higher proportion (P < 0.001) of pre-sarcopenia when appendicular lean mass was adjusted for body mass index (42%) compared to PCa (15%) and healthy (7%) controls. Men treated with ADT had 15-36% (P < 0.05) greater storage of fat within subcutaneous depots when compared to controls, whereas visceral and intermuscular fat was similar. The majority of subcutaneous fat depots (excluding android region) were shown to be positively associated with ADT duration (P < 0.05). Forearm muscle density was shown to negatively correlate with ADT duration (P < 0.05). The RCT had a high participant retention rate (96%). Adherence was high for the supplement (mean, 92-93%) and modest for the exercise program (mean, 60%). A relatively high proportion (81%) of men in the intervention group reported an adverse event, although only 16% were confirmed to be related to the intervention and the vast majority (97%) were determined to be mild or moderate in terms of severity. Across the ten separate recruitment pathways considered, clinician referral (43%) and PCa support groups (29%) yielded the greatest proportion of enrolled participants. A total of 149 potential participants were screened, which resulted in 42 participants at the time of write up for this thesis. Among the first 28 participants to complete the 26-week intervention, 21-50% were unable to complete at least one measure of muscle strength due to pre-existing comorbidities. Data from the initial 28 participants tended to show that when compared to usual care, Ex+ProCaD led to net improvements in lean mass (0.2-1.4 kg), fat mass (-0.1 to -0.9 kg), muscle strength (8.0-19%), functional muscle power (8.6%) and functional capacity (12-14%). Conclusions: The following key themes emerged from this thesis and may be used to guide clinical practice guidelines and future research: 1) Men treated with ADT for PCa had greater amounts of fat when compared to non-ADT counterparts, 2) Current definitions of sarcopenia and sarcopenic obesity were limited in men treated with ADT for PCa, 3) The greater amounts of fat observed in men treated with ADT for PCa tended to be stored in subcutaneous depots and supersede age-related plateaus/losses, 4) The recruitment of men treated with ADT for PCa into a lifestyle intervention was challenging, and 5) Men treated with ADT for PCa tended to respond positively to a multi-modal exercise training combined with multi-nutrient supplementation.

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Randomized Trial to Assess the Impact of Venlafaxine and Soy Protein on Hot Flashes and Quality of Life in Men With Prostate Cancer

Cited by 38 publications

References 19 publications

Exercise improves quality of life in androgen deprivation therapy-treated prostate cancer: systematic review of randomised controlled trials

Exercise improves quality of life in androgen deprivation therapy-treated prostate cancer: systematic review of randomised controlled trials

Survivorship and Improving Quality of Life in Men with Prostate Cancer

Muscle, fat and performance during androgen deprivation for prostate cancer

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