An interventional study of Rehabilitation programme in Esophageal Cancer, sponsored by University of Dublin, Trinity College. Completed at 1 site in Ireland. Per ClinicalTrials.gov, last updated 2017-10-19.
Sponsored by University of Dublin, Trinity College · Not applicable, Interventional, and Treatment
Among 26 studies in Esophageal Neoplasms with a site in Ireland — 4 open to participants now, 6 under way, 2 of them phase 3. Esophageal Neoplasms · Ireland.
Among the 26 studies in Esophageal Neoplasms with a site in Ireland, this one is the 12th largest by enrollment of the 17 interventional ones that give a count, is one of 3 that started in 2014, is one of 10 with no phase, and was the 9th registered.
1,873 studies on the registry are indexed under Esophageal Neoplasms; 501 are open to participants now.
Browse Esophageal Neoplasms studies →4 of the 26 studies in Esophageal Neoplasms with a site in Ireland are open now. Recruiting first, the newest first:
University Hospital, Antwerp · Sites in Ireland, Belgium, Denmark and 3 more countries
St. James's Hospital, Ireland · Sites in Ireland
Universitaire Ziekenhuizen KU Leuven · Sites in Ireland, United States, Belgium and 3 more countries
University of Dublin, Trinity College · Sites in Ireland, Germany, Italy and 2 more countries
A study can be open while its sites in Ireland have not opened yet or have stopped. Only those recruiting at a site in Ireland →
Of the 387 Esophageal Neoplasms studies recruiting now, 245 (63%) set no upper age limit and 75 (19%) stop at 75 or younger; 19 take children under 18; 36 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
26 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 2 · Phase 3 3 · Phase 4 1
First in 2005; this study’s year is marked. 3 started in 2014.
This study's enrollment of 44 is below the median of 58 across 1,347 interventional studies indexed under Esophageal Neoplasms.
Median enrollment 64 across the 17 interventional studies, 384 across the 9 observational. Of the 16 that completed or were terminated, 0 (0%) have results posted.
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2 of 26 have an industry lead sponsor. The 10 most frequent:
University of Dublin, Trinity College is the lead sponsor of 73 studies on the registry; 13 are open to participants now.
University of Dublin, Trinity College has 5 studies filed under Esophageal Neoplasms — fewer than ten, so there is no comparison to draw.
1 of the studies in Esophageal Neoplasms with a site in Ireland that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06115629Phase 3University of Dublin, Trinity CollegeSurveillance After Resection of Oesophageal aNd Gastric Cancer (SARONG-II) Trial | 2026-11 |
Among the 26 studies in Esophageal Neoplasms with a site in Ireland, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
12 week multi-disciplinary intervention prescribing exercise, individual dietary counselling and education sessions.
Behavioral: Rehabilitation programme
Usual care control arm
The RESTORE trial is a 12 week multi-disciplinary intervention involving exercise, nutrition advice and education sessions
Change in Aerobic Fitness
Aerobic fitness (ml/kg/min) will be measured by maximal cardiopulmonary exercise test
Time frame: Change from baseline in aerobic fitness at 12 weeks (end of intervention)
Change in physical activity levels
Physical activity (minutes per week) will be measured by accelerometry
Time frame: Change from baseline in physical activity at 12 weeks (end of intervention)
Change in hand grip strength
Hand grip strength (kg) will be measured by as an estimate of overall body strength
Time frame: Change from baseline in hand grip strength at 12 weeks (end of intervention)
Change in body Composition
Segmental body composition will be measured by bioelectrical impedence analysis. Sarcopenia will be assessment by PET-CT
Time frame: Change from baseline in body composition at 12 weeks (end of intervention)
Change in Dietary Intake
Food frequency questionnaire
Time frame: Change from baseline in dietary intake at 12 weeks (end of intervention)
Change in inflammatory status
Blood samples will be analysed for inflammatory cytokines (TNF-alpha and interleukin (IL)-6 as measured by multi-plex assays
Time frame: Change from baseline in inflammatory status at 12 weeks (end of intervention)
Change in energy metabolism
Blood samples will be analysed for measures of energy metabolism (citrate secretion and lactate secretion)
Time frame: Change from baseline in energy metabolism at 12 weeks (end of intervention)
Change in quality of Life
EORTC questionnaire will be used to measure QOL
Time frame: Change from baseline in quality of life at 12 weeks (end of intervention)
The record gives a start of Oct 2014, a primary completion of Jun 2017 and a completion of Jun 2017. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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University of Dublin, Trinity College