Ignite Creation Date:
2024-05-06 @ 9:13 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02930876
Status:
COMPLETED
Last Update Posted:
2017-03-07
First Post:
2016-09-02
Brief Title:
Feasibility of Home vs Hospital Based Resistance Training for Advanced Cancer Patients
Sponsor:
Kings College London
Organization:
Kings College London
Study Overview
Official Title:
Feasibility of Home vs Hospital Based Resistance Training for Advanced Cancer Patients a Phase II Trial
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cancer causes 82 million deaths each year with an estimated worldwide cost of 895 billion 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 ie 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
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 In 2010 a European Consensus defined sarcopenia as a triad of muscle mass loss decreased functional performance and muscle strength It has been reported as a hallmark of cancer with impact on prognosis response to treatments side effects of chemotherapy and recovery after surgery 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
Exercise in particular resistance training is one of the most powerful ways of increasing muscle mass and evidence from elderly patients suggests that it is among the most promising interventions for sarcopenia There is evidence that resistance training can be effective 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 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 produces better results than hospital the traditional location
Sarcopenia ie 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
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 In 2010 a European Consensus defined sarcopenia as a triad of muscle mass loss decreased functional performance and muscle strength It has been reported as a hallmark of cancer with impact on prognosis response to treatments side effects of chemotherapy and recovery after surgery 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
Exercise in particular resistance training is one of the most powerful ways of increasing muscle mass and evidence from elderly patients suggests that it is among the most promising interventions for sarcopenia There is evidence that resistance training can be effective 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 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 produces better results than hospital the traditional location
Detailed 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 the investigators 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 01052016 Overall trial end date 31032017 Condition Advanced cancer Interventions Resistance training at home resistance training at the hospital
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 the investigators 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 01052016 Overall trial end date 31032017 Condition Advanced cancer Interventions Resistance training at home resistance training at the hospital
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None