NCT03958019: RESTORE II

Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer

Status unknown NA Last updated 13 April 2022

What this trial tests

NA trial testing RESTORE II Program in Oesophageal Cancer in 120 participants. Status unknown.

Timeline

25 January 2022

Primary endpoint
1 June 2024

1 December 2024

Quick facts

Lead sponsor	University of Dublin, Trinity College
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	120
Start date	25 January 2022
Primary completion	1 June 2024
Estimated completion	1 December 2024
Sites	1 location across Ireland

Drugs / interventions tested

• RESTORE II Program

Conditions studied

• Oesophageal Cancer — all drugs for Oesophageal Cancer →
• Gastric Cancer — all drugs for Gastric Cancer →
• Liver Cancer — all drugs for Liver Cancer →
• Pancreatic Cancer — all drugs for Pancreatic Cancer →

Sponsor

University of Dublin, Trinity College

Who can join

18 and older, any sex, with Oesophageal Cancer or Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Rehabilitation strategies following oesophagogastric and Hepatopancreaticobiliary cancer (ReStOre II): a protocol for a randomized controlled trial.
   O'Neill L, Guinan E, Doyle S, Connolly D, et al · · 2020 · cited 20× · PMID 32404096 · DOI 10.1186/s12885-020-06889-z
2. The Human Microbiomes in Pancreatic Cancer: Towards Evidence-Based Manipulation Strategies?
   Brandi G, Turroni S, McAllister F, Frega G. · · 2021 · cited 15× · PMID 34576078 · DOI 10.3390/ijms22189914
3. 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 (SWA
   O'Neill L, Knapp P, Doyle SL, Guinan E, et al · · 2019 · cited 6× · PMID 33392438 · DOI 10.12688/hrbopenres.12950.2
4. ReStOre@Home: Feasibility study of a virtually delivered 12-week multidisciplinary rehabilitation programme for survivors of upper gastrointestinal (UGI) cancer - study protocol.
   O'Neill L, Guinan E, Brennan L, Brennan L, et al · · 2020 · cited 5× · PMID 34046552 · DOI 10.12688/hrbopenres.13185.2
5. Development and Initial Implementation of a Clinical Monitoring Strategy in a Non-regulated Trial: a research note from the ReStOre II Trial.
   O'Neill L, Murphy F, Reidy D, Poisson C, et al · · 2023 · cited 3× · PMID 39280895 · DOI 10.12688/hrbopenres.13763.3
6. Unlocking the Potential of Bioactive Compounds in Pancreatic Cancer Therapy: A Promising Frontier.
   Brugiapaglia S, Spagnolo F, Curcio C. · · 2025 · cited 1× · PMID 40427617 · DOI 10.3390/biom15050725
7. 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).
   O'Neill L, Knapp P, Doyle SL, Begic S, et al · · 2025 · PMID 40485109 · DOI 10.1111/hex.70321
8. Development and Initial Implementation of a Clinical Monitoring Strategy in a Non-regulated Trial: a research note from the ReStOre II Trial
   O'Neill L, Murphy F, Reidy D, Poisson C, et al · · 2024 · DOI 10.12688/hrbopenres.13763.3