NCT03314311

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 19, 2017

Completed
Last Updated

October 19, 2017

Status Verified

October 1, 2017

Enrollment Period

2.7 years

First QC Date

May 18, 2015

Last Update Submit

October 18, 2017

Conditions

Esophageal Cancer

Keywords

RehabilitationExerciseNutrition TherapyPatient Education as Topic

Outcome Measures

Primary Outcomes (1)

  • Change in Aerobic Fitness

    Aerobic fitness (ml/kg/min) will be measured by maximal cardiopulmonary exercise test

    Change from baseline in aerobic fitness at 12 weeks (end of intervention)

Secondary Outcomes (7)

  • Change in physical activity levels

    Change from baseline in physical activity at 12 weeks (end of intervention)

  • Change in hand grip strength

    Change from baseline in hand grip strength at 12 weeks (end of intervention)

  • Change in body Composition

    Change from baseline in body composition at 12 weeks (end of intervention)

  • Change in Dietary Intake

    Change from baseline in dietary intake at 12 weeks (end of intervention)

  • Change in inflammatory status

    Change from baseline in inflammatory status at 12 weeks (end of intervention)

  • +2 more secondary outcomes

Study Arms (2)

Rehabilitation Programme

EXPERIMENTAL

12 week multi-disciplinary intervention prescribing exercise, individual dietary counselling and education sessions.

Behavioral: Rehabilitation programme

Control

NO INTERVENTION

Usual care control arm

Interventions

Rehabilitation programmeBEHAVIORAL

The RESTORE trial is a 12 week multi-disciplinary intervention involving exercise, nutrition advice and education sessions

Rehabilitation Programme

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Evidence of active or recurrent disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St James's Hospital

Dublin, 8, Ireland

Location

Related Publications (2)

  • Kennedy SA, Annett SL, Dunne MR, Boland F, O'Neill LM, Guinan EM, Doyle SL, Foley EK, Elliott JA, Murphy CF, Bennett AE, Carey M, Hillary D, Robson T, Reynolds JV, Hussey J, O'Sullivan J. Effect of the Rehabilitation Program, ReStOre, on Serum Biomarkers in a Randomized Control Trial of Esophagogastric Cancer Survivors. Front Oncol. 2021 Sep 15;11:669078. doi: 10.3389/fonc.2021.669078. eCollection 2021.

    PMID: 34604026DERIVED

  • O'Neill LM, Guinan E, Doyle SL, Bennett AE, Murphy C, Elliott JA, O'Sullivan J, Reynolds JV, Hussey J. The RESTORE Randomized Controlled Trial: Impact of a Multidisciplinary Rehabilitative Program on Cardiorespiratory Fitness in Esophagogastric cancer Survivorship. Ann Surg. 2018 Nov;268(5):747-755. doi: 10.1097/SLA.0000000000002895.

    PMID: 30004915DERIVED

MeSH Terms

Conditions

Esophageal NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesBehavior

Study Officials

  • Juliette Hussey, PhD

    University of Dublin, Trinity College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 18, 2015

First Posted

October 19, 2017

Study Start

October 1, 2014

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

October 19, 2017

Record last verified: 2017-10

Locations

IE(1)