Oesophageal CancerRESTORE IINCT03958019
Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer
A study testing RESTORE II Program in people with Oesophageal Cancer and Gastric Cancer, run by University of Dublin, Trinity College at 1 site in Ireland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oesophageal Cancer, Gastric Cancer, Liver Cancer
- What is being tested?
- RESTORE II Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIreland
- Study dates
- 25 Jan 2022to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Ongoing serious post-operative morbidity
- Evidence of active or recurrent disease
- Co-morbidities that would preclude safe exercise participation;
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Trinity College
Dublin, Leinster, D08 W9RT
Linda O'Neill, PhD, +35318964809, oneilll8@tcd.ie
About this study
Official title: Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer (RESTORE II) - A Randomised Controlled Trial
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.
Read the detailed description
Curative treatment for upper gastrointestinal (UGI) cancers is associated with numerous side-effects including sarcopenia and nutritional compromise, increasing morbidity, compromising functional capacity and decreasing health-related quality of life (HR-QOL) in survivorship. As survival improves in UGI cancer, there is increasing focus on optimizing survivorship, however research examining rehabilitation programs in this newly-emergent complex clinical cohort is lacking.
The investigators recently designed, implemented, and evaluated the Rehabilitation Strategies following Oesophagogastric Cancer (RESTORE) program, a novel multidisciplinary rehabilitation program tailored for oesophagogastric cancer survivorship. The feasibility and preliminary efficacy of the RESTORE program was established and there is now recognized need to further examine program efficacy in a definitive trial.
Using a convergent parallel mixed-methods design, RESTORE II, implemented as a 2-armed randomized controlled trial, will examine if multidisciplinary rehabilitation can improve functional capacity and HRQOL in UGI cancer survivors. RESTORE II will prescribe a 12-week program of supervised aerobic and resistance training, self-directed unsupervised exercise, individualized dietetic counselling and multidisciplinary education for patients who are >3 months following oesophagectomy, gastrectomy, pancreaticoduodenectomy, or major liver resection. A sample of 60 participants per arm will be recruited to establish a mean increase in functional capacity (cardio-respiratory fitness) of 3.5 ml/kg/min with 90% power, 5% significance and 20% drop-out.
Quantitative assessments including cardiopulmonary fitness and functional exercise capacity will be completed at baseline, post-intervention and 3-months post-intervention (Objective 1). HR-QOL will be quantitatively assessed pre and post-intervention, at 3-months post-intervention and 1 year post-enrollment (Objective 2). Impact on physical, mental and social well-being will be qualitatively examined during focus groups immediately post-intervention and 3-months post-intervention (Objective 3). The implementation costs of RESTORE II will be analysed in consideration of clinician salaries, overheads and equipment costs (Objective 4). Bio-samples will be collected pre and post-intervention and 3-months post-intervention, establishing the first National UGI Cancer Survivorship Biobank (Objective 5). A patient centered approach to enhancing trial recruitment in this complex cohort will also be evaluated (Objective 6).
Following this evaluation, the RESTORE II program will provide a unique model of multidisciplinary rehabilitation in nutritionally complex UGI cancer survivors.
- Conditions
- Oesophageal Cancer, Gastric Cancer, Liver Cancer, Pancreatic Cancer
- Being tested
- RESTORE II Program
- Keywords
- Rehabilitation, Exercise, Diet, Education, Survivor-ship
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms, Liver Neoplasms, Pancreatic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESTORE II ProgramOther
Detailed in arm description
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Other: RESTORE II Program |
| Control | No intervention | Usual care control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cardiorespiratory Fitness from Baseline
Cardiorespiratory fitness will be determined by Cardiopulmonary Exercise Test (CPET)
Measured: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Secondary outcomes (19)
Physical Performance
Physical Performance will be measured with the Short Physical Performance Battery (SPPB)
Measured: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Lower Limb Muscle Strength
Lower limb muscle strength (llbs)will be measured by a leg press 1-RM
Measured: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Hand Grip Strength
Hand grip strength (kg) will be measured with hand held dynamometry
Measured: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Physical Activity
Physical Activity levels will be measured by accelerometry (ACTIGRAPH GT3X+)
Measured: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Body Mass Index
Body mass index will be measured as the ratio of weight (kg) to height in metres squared.
Measured: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Waist Circumference
Waist circumference (cm) will be measured at the mid-point between the iliac crest and the 12th rib following gentle expiration.
Measured: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Mid Arm Circumference
Mid Arm circumference (cm) will be measured at the mid-point between the olecranon process of the ulna and the acromion process of the scapula.
Measured: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Fat Mass
Fat mass(kg) will be measured with the Seca mBCA 515.
Measured: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Fat Free Mass
Fat free mass (kg) will be measured with the Seca mBCA 515.
Measured: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Skeletal Muscle Mass
Skeletal muscle mass(kg) will be measured with the Seca mBCA 515.
Measured: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Dietary Quality
Dietary quality will be scored using the WCRF/AICR index which determines adherence to healthy eating guidelines for cancer survivors.
Measured: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Health Related Quality of Life
Quality of Life will be determined by the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30).
Scores are reported on a linear scale from 0-100. A high score in a functional scale indicates greater function. A high score in a symptom scale indicates greater symptom burden.
Measured: Baseline (T0), Immediately after the program intervention (T1), Three month Follow-up (T2), One-year post intervention (T3)
Health Related Quality of Life (Specific to Oesophago-gastric cancer)
For Oesophago-gastric Cancer Patients Quality of Life will be further assessed with the European Organisation for Research and Treatment of Cancer Oesophago-gastric Cancer Subscale the QLQ-OG25.
Scores are reported on a linear scale from 0-100. A high score in a functional scale indicates greater function. A high score in a symptom scale indicates greater symptom burden.
Measured: Baseline (T0), Immediately after the program intervention (T1), Three month Follow-up (T2), One-year post intervention (T3)
Health Related Quality of Life (Specific to Hepatocellular carcinoma)
For Liver Cancer Patients Quality of Life will be further assessed with the European Organisation for Research and Treatment of Cancer Core Hepatocellular carcinoma subscale (QLQ-HCC18) Scores are reported on a linear scale from 0-100. A high score in a functional scale indicates greater function. A high score in a symptom scale indicates greater symptom burden.
Measured: Baseline (T0), Immediately after the program intervention (T1), Three month Follow-up (T2), One-year post intervention (T3)
Health Related Quality of Life (Specific to Pancreatic carcinoma)
For Pancreatic Cancer Patients Quality of Life will be further assessed with the European Organisation for Research and Treatment of Cancer Pancreatic cancer Subscale (QLQ-PAN26).
Scores are reported on a linear scale from 0-100. A high score on a functional scale indicates greater function. A high score on a symptom scale indicates greater symptom burden.
Measured: Baseline (T0), Immediately after the program intervention (T1), Three month Follow-up (T2), One-year post intervention (T3)
Fatigue
Fatigue will be assessed using the Multidimensional Fatigue Inventory (MFI-20) questionnaire. It is scored from 0-20. A cut off score of >or =13 indicates severe fatigue.
Measured: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Qualitative Approach
Focus groups and interviews will be carried out with participants from the intervention arm to gain their perspectives of the impact of the program on physical and mental well-being.
Measured: Immediately after the program intervention and Three-months post intervention
Cost Analysis
The costs of the program will be set against the effects on HRQOL
Measured: Up to 1 year post program completion
Bio-sample Collection
Serum and Plasma samples will be collected at each time-point to establish a survivorship Biobank for UGI cancer.
Measured: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start25 Jan 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Oesophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Convergent parallel mixed methods design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Collaborators
- Health Research Board, Ireland, St. James's Hospital, Ireland, St Vincent's University Hospital, Ireland, Tallaght University Hospital
- Responsible party
- Principal investigator, Prof Juliette Hussey, University of Dublin, Trinity College
- Investigators
- Juliette Hussey, PhD, Principal investigator, Professor in Physiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958019
- Sponsor's protocol ID
- HRB-DIFA RESTORE II Trial
- Acronym
- RESTORE II
- Status last verified
- Apr 2022
- First submitted
- 2 Apr 2019
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
O'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.
PubMed 40485109O'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.
PubMed 39280895O'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.
PubMed 33392438O'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.
PubMed 32404096
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer (RESTORE II) - A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03958019
- Acronym / sponsor ID
- RESTORE II / HRB-DIFA RESTORE II Trial
- Conditions
- Oesophageal Cancer, Gastric Cancer, Liver Cancer, Pancreatic Cancer
- Keywords
- Rehabilitation, Exercise, Diet, Education, Survivor-ship
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Collaborators
- Health Research Board, Ireland, St. James's Hospital, Ireland, St Vincent's University Hospital, Ireland, Tallaght University Hospital
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Curative treatment for upper gastrointestinal (UGI) cancers is associated with numerous side-effects including sarcopenia and nutritional compromise, increasing morbidity, compromising functional capacity and decreasing health-related quality of life (HR-QOL) in survivorship. As survival improves in UGI cancer, there is increasing focus on optimizing survivorship, however research examining rehabilitation programs in this newly-emergent complex clinical cohort is lacking.
The investigators recently designed, implemented, and evaluated the Rehabilitation Strategies following Oesophagogastric Cancer (RESTORE) program, a novel multidisciplinary rehabilitation program tailored for oesophagogastric cancer survivorship. The feasibility and preliminary efficacy of the RESTORE program was established and there is now recognized need to further examine program efficacy in a definitive trial.
Using a convergent parallel mixed-methods design, RESTORE II, implemented as a 2-armed randomized controlled trial, will examine if multidisciplinary rehabilitation can improve functional capacity and HRQOL in UGI cancer survivors. RESTORE II will prescribe a 12-week program of supervised aerobic and resistance training, self-directed unsupervised exercise, individualized dietetic counselling and multidisciplinary education for patients who are >3 months following oesophagectomy, gastrectomy, pancreaticoduodenectomy, or major liver resection. A sample of 60 participants per arm will be recruited to establish a mean increase in functional capacity (cardio-respiratory fitness) of 3.5 ml/kg/min with 90% power, 5% significance and 20% drop-out.
Quantitative assessments including cardiopulmonary fitness and functional exercise capacity will be completed at baseline, post-intervention and 3-months post-intervention (Objective 1). HR-QOL will be quantitatively assessed pre and post-intervention, at 3-months post-intervention and 1 year post-enrollment (Objective 2). Impact on physical, mental and social well-being will be qualitatively examined during focus groups immediately post-intervention and 3-months post-intervention (Objective 3). The implementation costs of RESTORE II will be analysed in consideration of clinician salaries, overheads and equipment costs (Objective 4). Bio-samples will be collected pre and post-intervention and 3-months post-intervention, establishing the first National UGI Cancer Survivorship Biobank (Objective 5). A patient centered approach to enhancing trial recruitment in this complex cohort will also be evaluated (Objective 6).
Following this evaluation, the RESTORE II program will provide a unique model of multidisciplinary rehabilitation in nutritionally complex UGI cancer survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Convergent parallel mixed methods design
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: RESTORE II Program12 week multidisciplinary program consisting of; i) supervised and home-based aerobic and resistance training, ii) 1:1 dietary counselling, and iii) group education sessions. |
| Control | No intervention | –Usual care control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Ongoing serious post-operative morbidity
- Evidence of active or recurrent disease
- Co-morbidities that would preclude safe exercise participation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RESTORE II ProgramDetailed in arm description | Other | Intervention Group |
Primary outcome
Change in Cardiorespiratory Fitness from Baseline
Time frame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Cardiorespiratory fitness will be determined by Cardiopulmonary Exercise Test (CPET)
19 secondary outcomes
Physical Performance
Time frame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Lower Limb Muscle Strength
Time frame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Hand Grip Strength
Time frame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Physical Activity
Time frame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Body Mass Index
Time frame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Waist Circumference
Time frame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Mid Arm Circumference
Time frame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Fat Mass
Time frame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Fat Free Mass
Time frame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Skeletal Muscle Mass
Time frame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Dietary Quality
Time frame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Health Related Quality of Life
Time frame: Baseline (T0), Immediately after the program intervention (T1), Three month Follow-up (T2), One-year post intervention (T3)
Health Related Quality of Life (Specific to Oesophago-gastric cancer)
Time frame: Baseline (T0), Immediately after the program intervention (T1), Three month Follow-up (T2), One-year post intervention (T3)
Health Related Quality of Life (Specific to Hepatocellular carcinoma)
Time frame: Baseline (T0), Immediately after the program intervention (T1), Three month Follow-up (T2), One-year post intervention (T3)
Health Related Quality of Life (Specific to Pancreatic carcinoma)
Time frame: Baseline (T0), Immediately after the program intervention (T1), Three month Follow-up (T2), One-year post intervention (T3)
Fatigue
Time frame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Qualitative Approach
Time frame: Immediately after the program intervention and Three-months post intervention
Cost Analysis
Time frame: Up to 1 year post program completion
Bio-sample Collection
Time frame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Derived from this study: PubMed 40485109O'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.
- Derived from this study: PubMed 39280895O'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.
- Derived from this study: PubMed 33392438O'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.
- Derived from this study: PubMed 32404096O'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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliette Hussey, PhD principal investigator
Professor in Physiotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RESTORE II Program in people with Oesophageal Cancer and Gastric Cancer, run by University of Dublin, Trinity College at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linda O'Neill, PhD (+35318964809, oneilll8@tcd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cardiorespiratory Fitness from Baseline (time frame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03958019, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.