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Feasibility of Home vs. Hospital Based Resistance Training for Advanced Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02930876
Recruitment Status : Completed
First Posted : October 12, 2016
Last Update Posted : March 7, 2017
Sponsor:
Collaborators:
Calouste Gulbenkian Foundation
Centro Hospitalar Lisboa Central
Information provided by (Responsible Party):
King's College London

Tracking Information
First Submitted Date  ICMJE September 2, 2016
First Posted Date  ICMJE October 12, 2016
Last Update Posted Date March 7, 2017
Study Start Date  ICMJE July 2016
Actual Primary Completion Date February 8, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2016)
  • Number of training sessions completed [ Time Frame: 3 months after baseline (at the end of the training program) ]
    Feasibility of the two intervention models assessed by the number of sessions completed
  • Number of exercises done within each session [ Time Frame: 3 months after baseline (at the end of the training program) ]
    Feasibility of the two intervention models assessed by the number of exercises completed in each session
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2016)
  • Tolerability [ Time Frame: 3 months after baseline (at the end of the training program) ]
    Tolerability defined as the patients' perception of whether the program is tolerable on a Likert scale at 3 months after enrollment
  • Safety of the exercise program [ Time Frame: 3 months after baseline (at the end of the training program) ]
    Evaluated as the number of adverse events due to the exercise program
  • Change in muscle mass after the 3 months of exercise [ Time Frame: Reported at baseline and 3 months after enrolment; ]
    to explore the effect of the interventions on muscle mass measured by DXA
  • Frequency of treatment related toxicities [ Time Frame: Reported at baseline and 3 months after enrolment; ]
    to explore the effect of the interventions on treatment related toxicities reported according to Common Toxicity Criteria for Adverse Events
  • Change in strength after the 3 months of exercise [ Time Frame: Reported at baseline and 3 months after enrolment; ]
    to explore the effect of the interventions on strength assessed through sit to stand transitions
  • Change in functional capacity after the 3 months of exercise vs controls [ Time Frame: Reported at baseline and 3 months after enrolment; ]
    to explore the effect of the interventions on functional capacity assessed though 6 minute walking test
  • Change in quality of life after the 3 months of exercise vs controls [ Time Frame: Reported at baseline and 3 months after enrolment; ]
    to explore the effect of the interventions on quality of life assessed using EORTC QoL C30
  • Change in fatigue after the 3 months of fatigue vs controls [ Time Frame: Reported at baseline and 3 months after enrolment; ]
    to explore the effect of the interventions on fatigue assessed using Brief Fatigue Inventory
  • Health resources use [ Time Frame: 3 months after baseline (at the end of the training program) ]
    number of unplanned medical appointments, acute and emergency visits and hospital admissions
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility of Home vs. Hospital Based Resistance Training for Advanced Cancer Patients
Official Title  ICMJE Feasibility of Home vs. Hospital Based Resistance Training for Advanced Cancer Patients: a Phase II Trial
Brief Summary

Cancer causes 8.2 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 (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).

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Advanced Cancer
Intervention  ICMJE Behavioral: Resistance training
Set of muscle strengthening exercises of all major muscle groups, guided by physiotherapists.
Study Arms  ICMJE
  • Experimental: Resistance training at home
    Participants will undergo training sessions at their own homes. The exercise program will be individualized and guided by trained physiotherapists, for 3 months completion, aiming at 2-3 sessions a week (27 to 40 sessions in total), each lasting 45-60 minutes.
    Intervention: Behavioral: Resistance training
  • Experimental: Resistance training at the hospital
    Participants will undergo training sessions at the hospital. The exercise program will be individualized and guided by trained physiotherapists, for 3 months completion, aiming at 2-3 sessions a week (27 to 40 sessions in total), each lasting 45-60 minutes.
    Intervention: Behavioral: Resistance training
  • No Intervention: Controls
    Participants will be given an information leaflet with the exercise recommendations of the Portuguese national ministry of health.
Publications * Ribeiro C, Santos R, Correia P, Maddocks M, Gomes B. Resistance training in advanced cancer: a phase II safety and feasibility trial-home versus hospital. BMJ Support Palliat Care. 2020 Aug 13. pii: bmjspcare-2020-002230. doi: 10.1136/bmjspcare-2020-002230. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2016)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 8, 2017
Actual Primary Completion Date February 8, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- histological diagnosis of cancer, incurable (stage IIIB/IV according to AJCC 2010).

Exclusion Criteria:

  • chemotherapy within 90 days prior to study enrollment
  • not having a baseline (pre-treatment) Computed Tomography of the Thorax Abdomen and Pelvis (CTTAP) and whole body dual x-ray absorptometry (DXA) (this is important because having an assessment of baseline muscle mass will allow us to control for baseline sarcopenia and calculate changes from baseline to post-intervention)
  • bone metastasis in risk of fracture
  • inability to comply with the intervention for any known reasons (including physical or mental impairment that limits the capacity to undertake the exercise program)
  • considered to be at cardiovascular risk (defined by a pre-exercise cardiologic evaluation with electrocardiogram (ECG) and echocardiogram when indicated (echocardiogram if >50 years old, NYHA class I, angor, cardiovascular risk factors and abnormal ECG)).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02930876
Other Study ID Numbers  ICMJE HR-15/16-2960
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Presentation in conferences and publication in peer reviewed journals
Current Responsible Party King's College London
Original Responsible Party Same as current
Current Study Sponsor  ICMJE King's College London
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Calouste Gulbenkian Foundation
  • Centro Hospitalar Lisboa Central
Investigators  ICMJE Not Provided
PRS Account King's College London
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP