- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03314311
Rehabilitative Strategies Following Oesophageal Cancer (ReStOre)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The principal study proposed in this work will be composed of two phases. Phase I will consist of a longitudinal analysis, tracking the progression of cachexia and associated dysmetabolic state throughout treatment for oesophageal cancer (OC) and examining the impact of this decline on measures of physical functioning. A total of 88 newly-diagnosed OC patients will be recruited for Phase I. In Phase II, participants from Phase I will be re-assessed and if deemed suitable, will be enrolled onto a multidisciplinary team rehabilitation programme aimed at improving functional status. This rehabilitation programme will take the form of a randomised controlled trial (RCT) and will be based on the well-established cardiac rehabilitation programme model. It is anticipated that approximately 50% of participants enrolled onto Phase I will be suitable for progression to Phase II.
Outcomes The primary outcome across both Phase I and Phase II is functional capacity. Secondary outcomes including inflammatory status, energy metabolism and nutritional status will be measured as appropriate during the study. All outcomes are discussed in detail elsewhere.
Phase I: Longitudinal Study Examining the impact of progressive cachexia, dysmetabolism and cancer treatment on functional capacity in OC patients
Phase I will be designed as a longitudinal analysis, commencing at the time of diagnosis, tracking the progression of cachexia and associated dysmetabolic state, incorporating inflammatory profiles, energy metabolism (oxidative phosphorylation and glycolysis) and gut hormones, throughout treatment for OC and examining the impact of this decline on measures of physical functioning. Assessments will be completed at diagnosis (T0), cycle 2 chemotherapy (T1), cycle 3 chemotherapy (T2), pre-oesophagectomy (T3), post-oesophagectomy (T4), 4-weeks post-surgery (T5) and six months post-surgery (T6). All assessments will be completed during the same day as routine out-patient appointments thereby reducing the burden on participants. Furthermore, blood samples will be taken during routine clinical sampling and CT scans will be completed as part of routine medical care.
Phase II: Randomised Controlled Trial Can rehabilitation following curative treatment for OC optimise health-related functional outcomes?
Phase II will examine the effect of a 12-week rehabilitation programme, incorporating a walking intervention, individualised nutritional advice and education session, on functional status following curative treatment for OC. Following completion of Phase I and medical clearance to progress to Phase II, participants will be randomised 1:1 to either the intervention group or a control group. The control group will not receive the intervention however following completion of final assessments, participants will be offered an individual exercise and dietary session with the research physiotherapist and dietitian. During the intervention period, participants in the control group will continue to receive routine medical care.
The primary outcome for the multidisciplinary rehabilitation programme will be a change in functional capacity as measured by aerobic capacity. Secondary measures of functional capacity will include a stair climbing test, hand grip and physical activity. Body composition will also be measured by bio impedance analysis. The secondary outcomes that will be assessed are nutritional status, dietary quality and healthy related quality of life (QOL). Inflammatory profiles, measures of energy metabolism and gut hormones are unlikely to be influenced by the proposed rehabilitative intervention and therefore will not be measured. Assessments will be completed at, programme completion and three months post programme completion. Assessments take place at the Welcome Trust-HRB Clinical Research Facility St. James's Hospital. The rehabilitation programme will consist of three main components; 1. Exercise session, 2. Dietary sessions and 3. Education sessions. The intervention outlined below is devised based best evidence, pilot data and clinical expertise. The design final design will be informed form the results of the feasibility study and from needs identified in Phase I.
Exercise Sessions The exercise component of the rehabilitation programme will take the form of a 12 week supervised and home-based walking intervention. A walking intervention was chosen as walking is the most common form of exercise completed by adults nationally and worldwide, it is safe and feasible for deconditioned cohorts and represents a functionally meaningful activity. The feasibility of implementing a similar programme in cancer survivors has been previous established.
Group walking sessions will be supervised twice weekly during the first four weeks of the programme to re-introduce exercise to participant's lives in a safe and structured manner. As the programme progresses the frequency of supervised sessions will decrease to increase participants independence with the protocol. In the absence of guidance on appropriate exercise prescription in cancer cohorts, exercise intensity will be prescribed in accordance with the American College of Sports Medicine (ACSM) guidelines for exercise in deconditioned populations (28). Initially, activity will be prescribed at a light intensity and will progress during the programme to a moderate aerobic intensity. The proposed starting intensity is based on pilot data from the investigators institute suggesting that aerobic fitness levels are either 'poor' or 'very poor' in the early post-treatment phase. Participants will wear Polar Heart Rate monitors during all sessions to ensure compliance with the exercise prescribed. The goal at programme completion will be participation in 30 minutes of moderate intensity activity five days per week, as per the ACSM physical activity guidelines.
Nutrition Sessions Nutrition sessions will be delivered during week 1, week 2 and then fortnightly on a one to one basis. Weight and circumferential measures will be recorded at each session and dietary intake will be assessed as described previously.
The education delivered in the nutrition sessions will be individualised to participants needs. There is limited knowledge of the specific nutritional needs of oesophageal cancer survivors. Based on experience at this centre, the investigators anticipate that a heterogeneous mix of dietary issues requiring intervention will present in this cohort. These include persistent weight loss, anorexia, gastrointestinal disturbance and altered bowel habit. In addition, participants may require specific dietary advice to reduce the risk of other diseases e.g. cardio-protective dietary advice. Furthermore, the increase in physical activity by participants throughout the intervention will require dietary monitoring and advice to avoid inappropriate negative energy balance.
The feasibility study will assist in identifying specific nutritional issues facing oesophageal cancer survivors and help inform content and delivery of the nutrition education sessions. The target for participants is optimal dietary intake in line with the WCRF guidelines for cancer survivors. Supporting literature detailing prescriptive dietary advice will be developed and provided to participants.
Education Sessions Education sessions will be delivered weekly during weeks 1-4 and fortnightly thereafter by a range of members of the multidisciplinary team. As per the cardiac rehabilitation model, education sessions will talk place after the exercise session and cool-down, to monitor participant recovery following exercise. Education topics covered by the physiotherapist will include advice regarding physical activity guidelines, discouraging sedentary behaviour and overcoming barriers to physical activity. The dietitian will discuss dietary management of gastrointestinal symptoms and will also educate participants on healthy eating for cancer survivors as per World Cancer Research Fund, including practical advice and strategies to achieve dietary goals. Participants will be encouraged to highlight topics that may be of particular concern to them for discussion. As per the cardiac rehabilitation model, such topics may be covered by members of the multi-disciplinary team including the surgeon, gastrointestinal nurse, occupational therapist or social worker. Education sessions will take place at the Welcome Trust-HRB Clinical Research Facility St. James's Hospital.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Dublin, Ireland, 8
- St James's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rehabilitation Programme
12 week multi-disciplinary intervention prescribing exercise, individual dietary counselling and education sessions.
|
The RESTORE trial is a 12 week multi-disciplinary intervention involving exercise, nutrition advice and education sessions
|
No Intervention: Control
Usual care control arm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change from baseline in aerobic fitness at 12 weeks (end of intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change from baseline in physical activity at 12 weeks (end of intervention)
|
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
|
Change from baseline in hand grip strength at 12 weeks (end of intervention)
|
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
|
Change from baseline in body composition at 12 weeks (end of intervention)
|
Change in Dietary Intake
Time Frame: Change from baseline in dietary intake at 12 weeks (end of intervention)
|
Food frequency questionnaire
|
Change from baseline in dietary intake at 12 weeks (end of intervention)
|
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
|
Change from baseline in inflammatory status at 12 weeks (end of intervention)
|
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)
|
Change from baseline in energy metabolism at 12 weeks (end of intervention)
|
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
|
Change from baseline in quality of life at 12 weeks (end of intervention)
|
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HRA-POR-2014-535
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Esophageal Cancer
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityWithdrawnStage IIB Esophageal Cancer AJCC v7 | Stage III Esophageal Cancer AJCC v7 | Stage IIIA Esophageal Cancer AJCC v7 | Stage IIIB Esophageal Cancer AJCC v7 | Stage IIIC Esophageal Cancer AJCC v7
-
National Cancer Institute (NCI)NRG OncologyCompletedEsophageal Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | Stage IIA Esophageal Cancer AJCC v7 | Stage IIB Esophageal Cancer AJCC v7 | Stage IIIA Esophageal Cancer AJCC v7 | Stage IIIB Esophageal Cancer AJCC v7 | Stage IB Esophageal Cancer AJCC v7United States
-
AIO-Studien-gGmbHBristol-Myers SquibbCompletedEsophageal Cancer | Gastrooesophageal Cancer | Oesophageal Cancer | GastroEsophageal Cancer | Esophageal Cancers NOS | Oesophageal Cancer Metastatic | Esophageal Cancer Metastatic | Oesophageal Cancer NosGermany
-
Cancer Institute and Hospital, Chinese Academy...Tianjin Medical University Cancer Institute and Hospital; Sichuan Cancer Hospital...UnknownEsophageal Neoplasm | Esophageal Cancer TNM Staging Primary Tumor (T) T3 | Esophageal Cancer TNM Staging Primary Tumor (T) T2 | Esophageal Cancer TNM Staging Regional Lymph Nodes (N) N0 | Esophageal Cancer TNM Staging Distal Metastasis (M) M0China
-
University of Wisconsin, MadisonActive, not recruitingResectable Esophageal Cancer | GastroEsophageal CancerUnited States
-
Tianjin Medical University Cancer Institute and...Sun Yat-sen University; Cancer Institute and Hospital, Chinese Academy of Medical... and other collaboratorsNot yet recruitingStage III Esophageal Cancer | Stage II Esophageal Cancer
-
Tianjin Medical University Cancer Institute and...UnknownStage III Esophageal Cancer | Stage II Esophageal CancerChina
-
Academisch Medisch Centrum - Universiteit van Amsterdam...UMC UtrechtCompletedEsophageal Cancer, Stage II | Esophageal Cancer Stage IIINetherlands
-
Tianjin Medical University Cancer Institute and...The First Affiliated Hospital with Nanjing Medical University; The First Affiliated... and other collaboratorsUnknownEsophageal Cancer Stage III | Esophageal Cancer Stage IIBChina
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedGastroesophageal Junction Adenocarcinoma | Stage IIA Esophageal Cancer AJCC v7 | Stage IIB Esophageal Cancer AJCC v7 | Stage IIIA Esophageal Cancer AJCC v7 | Stage IIIB Esophageal Cancer AJCC v7 | Stage IIIC Esophageal Cancer AJCC v7 | Malignant Neoplasm of the Cervical Esophagus | Malignant Neoplasm...United States
Clinical Trials on Rehabilitation programme
-
Universidad San JorgeHospital Royo Villanova; Hospital Real Nuestra Señora de GraciaCompletedFatigue | Coronavirus | Musculoskeletal ComplicationSpain
-
Bnai Zion Medical CenterUnknown
-
Leiden University Medical CenterDutch Cancer SocietyUnknownCervical Cancer | Gynecologic Cancer | Endometrial Cancer | Vaginal CancerNetherlands
-
Royal Brompton & Harefield NHS Foundation TrustUnknownLung Diseases | Bronchiectasis | Emphysema | Cystic Fibrosis | Alveolitis, FibrosingUnited Kingdom
-
KU LeuvenVrije Universiteit Brussel; AZ HerentalsRecruitingStroke | Chronic Disease | Spinal Cord InjuriesBelgium
-
Glostrup University Hospital, CopenhagenUnknownChronic Obstructive Pulmonary DiseaseDenmark
-
University Hospital of FerraraRecruiting
-
Manchester Metropolitan UniversityBrecon Beacons National Park AuthorityCompleted
-
Istanbul Physical Medicine Rehabilitation Training...CompletedAnxiety Disorders | Post-stroke DepressionTurkey
-
Philipps University Marburg Medical CenterDept. of Child and Adolescent Psychiatry, Philipps University Marburg; Rexrodt...CompletedBreast CancerGermany