A phase III randomized, double-blind, placebo-controlled trial of gabapentin in the management of hot flashes in men (N00CB)

ObjectiveTo explore ongoing symptoms, unmet needs, psychological wellbeing, self-efficacy and overall health status in survivors of prostate cancer. Patients and MethodsAn invitation to participate in a postal questionnaire survey was sent to 546 men, diagnosed with prostate cancer 9-24 months previously at two UK cancer centres. The study group comprised men who had been subject to a range of treatments: surgery, radiotherapy, hormone therapy and active surveillance. The questionnaire included measures of prostate-related quality of life (Expanded Prostate cancer Index Composite 26-item version, EPIC-26); unmet needs (Supportive Care Needs Survey 34-item version, SCNS-SF34); anxiety and depression (Hospital Anxiety and Depression Scale, HADS), self-efficacy (modified Self-efficacy Scale), health status (EuroQol 5D, EQ-5D) and satisfaction with care (questions developed for this study). A single reminder was sent to non-responders after 3 weeks. Data were analysed by age, co-morbidities, and treatment group. ResultsIn all, 316 men completed questionnaires (64.1% response rate). Overall satisfaction with follow-up care was high, but was lower for psychosocial than physical aspects of care. Urinary, bowel, and sexual functioning was reported as a moderate/big problem in the last month for 15.2% (n = 48), 5.1% (n = 16), and 36.5% (n = 105) men, respectively. The most commonly reported moderate/high unmet needs related to changes in sexual feelings/ relationships, managing fear of recurrence/uncertainty, and concerns about the worries of significant others. It was found that 17% of men (51/307) reported potentially moderate-to-severe levels of anxiety and 10.2% (32/308) reported moderate-to-severe levels of depression. The presence of problematic side-effects was associated with higher psychological morbidity, poorer selfefficacy, greater unmet needs, and poorer overall health status. ConclusionWhile some men report relatively few problems after prostate cancer treatment, this study highlights important physical and psycho-social issues for a significant minority of survivors of prostate cancer. Strategies for identifying those men with ongoing problems, alongside new interventions and models of care, tailored to individual needs, are needed to improve quality of life.

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“…Overall sexual function, n/N (%)* 115/289 (40) 54 (47) 12 (39) 28 (38) 9 (27) 11 (30) Vitality/hormonal function* Hot flushes,…”

Section: <0001mentioning

confidence: 99%

Symptoms, unmet needs, psychological well‐being and health status in survivors of prostate cancer: implications for redesigning follow‐up

et al. 2015

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“…Usually a simple explanation will do much to alleviate anxiety and is all that is required along with simple lifestyle modifications such as the avoidance of trigger factors, maintenance of a healthy body weight, regular exercise and the use of appropriate clothing, particularly at night. However, sometimes other strategies need to be employed, such as the use of non-hormonal therapies including selective serotonin reuptake inhibitors (Quella et al 1999), clonidine (Loprinzi et al 1994), or gabapentin (Loprinzi et al 2009) or hormonal therapies such as cyproterone acetate, medroxyprogesterone acetate or diethylstilbesterol (Irani et al 2010). Acupuncture and relaxation techniques , Ashamalla et al 2011) may also be considered.…”

Section: Hot Flushesmentioning

confidence: 99%

Androgen deprivation therapy complications

Allan¹,

Collins²,

Frydenberg³

et al. 2014

Endocrine-Related Cancer

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Androgen deprivation therapy (ADT) is increasingly used to treat advanced prostate cancer and is also utilised as adjuvant or neo-adjuvant treatment for high-risk disease. The resulting suppression of endogenous testosterone production has deleterious effects on quality of life, including hot flushes, reduced mood and cognition and diminished sexual function. Cross-sectional and longitudinal studies show that ADT has adverse bone and cardiometabolic effects. The rate of bone loss is accelerated, increasing the risk of osteoporosis and subsequent fracture. Fat mass is increased and lean mass reduced, and adverse effects on lipid levels and insulin resistance are observed, the latter increasing the risk of developing type 2 diabetes. ADT also appears to increase the risk of incident cardiovascular events, although whether it increases cardiovascular mortality is not certain from the observational evidence published to date. Until high-quality evidence is available to guide management, it is reasonable to consider men undergoing ADT to be at a higher risk of psychosexual dysfunction, osteoporotic fracture, diabetes and cardiovascular disease, especially when treated for extended periods of time and therefore subjected to profound and prolonged hypoandrogenism. Health professionals caring for men undergoing treatment for prostate cancer should be aware of the potential risks of ADT and ensure appropriate monitoring and clinical management.

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“…Acupuncture might be a suitable alternative. The evidence base for these recommendations consists of eleven publications of low quality [99][100][101][102][103][104][105][106][107][108][109] .…”

Section: Vasomotor Symptomsmentioning

confidence: 99%

Interventions to Address Sexual Problems in People with Cancer

et al. 2017

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A phase III randomized, double-blind, placebo-controlled trial of gabapentin in the management of hot flashes in men (N00CB)

Abstract: These results support that gabapentin decreases hot flashes, to a moderate degree, in men with androgen ablation-related vasomotor dysfunction.

Cited by 66 publications

References 20 publications

Symptoms, unmet needs, psychological well‐being and health status in survivors of prostate cancer: implications for redesigning follow‐up

Symptoms, unmet needs, psychological well‐being and health status in survivors of prostate cancer: implications for redesigning follow‐up

Androgen deprivation therapy complications

Interventions to Address Sexual Problems in People with Cancer

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