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Rehabilitative Strategies Following Oesophageal Cancer (ReStOre)

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: NCT03314311
Recruitment Status : Completed
First Posted : October 19, 2017
Last Update Posted : October 19, 2017
Sponsor:
Collaborator:
University College Dublin
Information provided by (Responsible Party):
Prof Juliette Hussey, University of Dublin, Trinity College

Brief Summary:
The ReStOre trial is a multi-disciplinary intervention of exercise, diet and education for patients who have completed treatment for oesophageal cancer. The intervention aims to improve quality of life and functional performance following oesophageal cancer and assist patients to return to normal activity during the early survivorship phase. The 12-week intervention will involve structured exercise training, individual dietary advice and multi-disciplinary education sessions addressing a range of survivorship needs.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Behavioral: Rehabilitation programme Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rehabilitative Strategies Following Oesophageal Cancer
Study Start Date : October 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Rehabilitation Programme
12 week multi-disciplinary intervention prescribing exercise, individual dietary counselling and education sessions.
Behavioral: Rehabilitation programme
The RESTORE trial is a 12 week multi-disciplinary intervention involving exercise, nutrition advice and education sessions

No Intervention: Control
Usual care control arm



Primary Outcome Measures :
  1. Change in Aerobic Fitness [ Time Frame: Change from baseline in aerobic fitness at 12 weeks (end of intervention) ]
    Aerobic fitness (ml/kg/min) will be measured by maximal cardiopulmonary exercise test


Secondary Outcome Measures :
  1. Change in physical activity levels [ Time Frame: Change from baseline in physical activity at 12 weeks (end of intervention) ]
    Physical activity (minutes per week) will be measured by accelerometry

  2. Change in hand grip strength [ Time Frame: Change from baseline in hand grip strength at 12 weeks (end of intervention) ]
    Hand grip strength (kg) will be measured by as an estimate of overall body strength

  3. Change in body Composition [ Time Frame: Change from baseline in body composition at 12 weeks (end of intervention) ]
    Segmental body composition will be measured by bioelectrical impedence analysis. Sarcopenia will be assessment by PET-CT

  4. Change in Dietary Intake [ Time Frame: Change from baseline in dietary intake at 12 weeks (end of intervention) ]
    Food frequency questionnaire

  5. Change in inflammatory status [ Time Frame: Change from baseline in inflammatory status at 12 weeks (end of intervention) ]
    Blood samples will be analysed for inflammatory cytokines (TNF-alpha and interleukin (IL)-6 as measured by multi-plex assays

  6. Change in energy metabolism [ Time Frame: Change from baseline in energy metabolism at 12 weeks (end of intervention) ]
    Blood samples will be analysed for measures of energy metabolism (citrate secretion and lactate secretion)

  7. Change in quality of Life [ Time Frame: Change from baseline in quality of life at 12 weeks (end of intervention) ]
    EORTC questionnaire will be used to measure QOL



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have completed treatment for oesophageal cancer to include oesophagectomy. Patients may have also been treated with neo-adjuvant or adjuvant chemotherapy or chemoradiotherapy.
  • Curative treatment intent.
  • Age >18 years
  • Able to understand English

Exclusion Criteria:

  • Evidence of active or recurrent disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03314311


Locations
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Ireland
St James's Hospital
Dublin, Ireland, 8
Sponsors and Collaborators
University of Dublin, Trinity College
University College Dublin
Investigators
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Principal Investigator: Juliette Hussey, PhD University of Dublin, Trinity College
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof Juliette Hussey, Professor, University of Dublin, Trinity College
ClinicalTrials.gov Identifier: NCT03314311    
Other Study ID Numbers: HRA-POR-2014-535
First Posted: October 19, 2017    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017
Keywords provided by Prof Juliette Hussey, University of Dublin, Trinity College:
Rehabilitation
Exercise
Nutrition Therapy
Patient Education as Topic