Clinical trial · Interventional
Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer
Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer (RESTORE II) - A Randomised Controlled Trial
NCT03958019CI-TRIAL-00057782RESTORE IIunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The RESTORE II randomized controlled trial will examine the efficacy of a 12 week multidisciplinary rehabilitation program consisting of supervised and home-based exercise,1:1 dietetic counselling, and group education sessions for survivors of upper gastrointestinal cancer, namely cancers of the oesophagus, stomach, pancreas, and liver.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Oesophageal Cancer | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RESTORE II Program | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Group
- description
- 12 week multidisciplinary program consisting of; i) supervised and home-based aerobic and resistance training, ii) 1:1 dietary counselling, and iii) group education sessions.
- interventionNames
- Other: RESTORE II Program
- type
- NO_INTERVENTION
- label
- Control
- description
- Usual care control group
Primary outcomes (1)
- measure
- Change in Cardiorespiratory Fitness from Baseline
- timeFrame
- Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
- description
- Cardiorespiratory fitness will be determined by Cardiopulmonary Exercise Test (CPET)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients \>3-months post oesophagectomy, total gastrectomy, pancreaticoduodenectomy or major liver resection +/- neo-adjuvant/adjuvant chemo/chemoradiotherapy with curative intent * Completion of adjuvant oncological therapy * Successful completion of baseline cardiopulmonary exercise test * Medical clearance to participate. Exclusion Criteria: * Ongoing serious post-operative morbidity * Evidence of active or recurrent disease * Co-morbidities that would preclude safe exercise participation;
References
Publications (4)
- DERIVEDO'Neill L, Knapp P, Doyle SL, Begic S, Smyth E, Kearney N, Grehan S, Parker A, Browne P, Segurado R, Connolly D, O'Sullivan J, Reynolds JV, Guinan E, Hussey J. Can a Public and Patient Involvement (PPI) Informed Participant Information Leaflet (PIL) Improve Trial Recruitment, Retention, and Quality of Decision Making? Results of a Randomised Controlled Double-Blind Study Within a Trial (SWAT). Health Expect. 2025 Jun;28(3):e70321. doi: 10.1111/hex.70321. PMID 40485109
- DERIVEDO'Neill L, Murphy F, Reidy D, Poisson C, Hussey J, Guinan E. Development and Initial Implementation of a Clinical Monitoring Strategy in a Non-regulated Trial: a research note from the ReStOre II Trial. HRB Open Res. 2024 Oct 18;6:46. doi: 10.12688/hrbopenres.13763.3. eCollection 2023. PMID 39280895
- DERIVEDO'Neill L, Knapp P, Doyle SL, Guinan E, Parker A, Segurado R, Connolly D, O'Sullivan J, Reynolds JV, Hussey J. Patient and family co-developed participant information to improve recruitment rates, retention, and patient understanding in the Rehabilitation Strategies Following Oesophago-gastric and Hepatopancreaticobiliary Cancer (ReStOre II) trial: Protocol for a study within a trial (SWAT). HRB Open Res. 2020 Nov 10;2:27. doi: 10.12688/hrbopenres.12950.2. eCollection 2019. PMID 33392438
- DERIVEDO'Neill L, Guinan E, Doyle S, Connolly D, O'Sullivan J, Bennett A, Sheill G, Segurado R, Knapp P, Fairman C, Normand C, Geoghegan J, Conlon K, Reynolds JV, Hussey J. Rehabilitation strategies following oesophagogastric and Hepatopancreaticobiliary cancer (ReStOre II): a protocol for a randomized controlled trial. BMC Cancer. 2020 May 13;20(1):415. doi: 10.1186/s12885-020-06889-z. PMID 32404096