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Feasibility of Home vs. Hospital Based Resistance Training for Advanced Cancer Patients: a Phase II Trial

2016-10-13 01:38:25 | BioPortfolio

Summary

Cancer causes 8.2 million deaths each year [1], with an estimated worldwide cost of $895 billion [2]. Pharmacological treatments provide improvements in expected survival and symptoms, but at cost of a high rate of toxicities and increased time spent by patients away from their homes and families during treatment. This is particularly important for patients with advanced disease as the timeframe at stake relates to their last months of life.

Sarcopenia (i.e. loss of muscle mass together with decreased functional capacity) has been widely reported as an important prognostic factor in advanced cancer, with impact on survival, toxicities, response to treatment and other patient-centered outcomes (such as functional capacity, quality of life and fatigue) [3].

Sarcopenia is a term first used in 1988 by Rosenberg, meaning an age-related loss in skeletal muscle mass and function. It was derived from the greek: sarx = flesh and penia = loss[6]. In 2010, a European Consensus defined sarcopenia as a triad of muscle mass loss, decreased functional performance and muscle strength [7]. It has been reported as a hallmark of cancer, with impact on prognosis, response to treatments, side effects of chemotherapy and recovery after surgery [8-12]. The prevalence of sarcopenia in advanced cancer seems to vary according to gender, stage, primary tumor location and treatments, being present in about 28 to 67% of patients [13-16].

Exercise, in particular resistance training, is one of the most powerful ways of increasing muscle mass17 and evidence from elderly patients suggests that it is among the most promising interventions for sarcopenia [7, 17-20]. There is evidence that resistance training can be effective[4] but evidence is still scarce for patients with advanced disease. Historically there have been some concerns regarding safety and efficacy for oncologic patients, and though evidence suggests that resistance training is one of the most preferred forms of exercise by patients [21], the effectiveness of resistance training alone on sarcopenia in patients with advanced cancer remains unknown. Another question is whether home (which seems to be the patients' preferred location for exercise [5] [21]) produces better results than hospital (the traditional location).

Description

Study hypothesis: Home is the preferred setting for resistance training programs in adults newly diagnosed with advanced cancer, compared to hospital or standard care alone.

AIM: to test the feasibility and clinical impact of home vs. hospital based resistance training programs in adults newly diagnosed with advanced cancer, compared to standard care.

Objective 1: to describe the feasibility (defined as acceptability, compliance, recruitment and retention) of the two intervention models and control; Secondary outcome measures: Objective 2: to test their tolerability (patients' perception) and safety (number of adverse events due to the exercise); Objective 3: to explore the effect of the interventions on clinical outcomes (muscle mass, treatment related toxicities, strength, functional capacity, quality of life, fatigue); Objective 4: to evaluate the associated health resources use (unplanned medical appointments, acute and emergency visits and hospital admissions) in the intervention and control arms.

Study design: we designed a three arm, randomised, open label, phase II trial, in advanced cancer patients, comparing 1) standard treatment concomitant with a resistance training program at home; 2) standard treatment concomitant with a resistance training program at the hospital; 3) standard treatment alone.

Overall trial start date: 01/05/2016 Overall trial end date: 31/03/2017 Condition: Advanced cancer Interventions: Resistance training at home, resistance training at the hospital

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Conditions

Advanced Cancer

Intervention

Resistance training

Location

King's College of London
London
United Kingdom
SE5 9PJ

Status

Recruiting

Source

King's College London

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-10-13T01:38:25-0400

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Medical and Biotech [MESH] Definitions

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