Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer

Pancreatic Cancer Clinical Trial

— RESTORE II  

Official title:

Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer (RESTORE II) - A Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03958019
• Other study ID #: HRB-DIFA RESTORE II Trial
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: April 2022
• Source: University of Dublin, Trinity College
• Contact: Linda O'Neill, PhD
• Phone: +35318964809
• Email: oneilll8[@]tcd.ie
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, pancreas, and liver.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Gastric Cancer
• Liver Cancer
• Oesophageal Cancer
• Pancreatic Cancer

Intervention

Other:
• RESTORE II Program
Detailed in arm description

Locations

Country	Name	City	State
Ireland	Trinity College	Dublin	Leinster

Sponsors (5)

Lead Sponsor	Collaborator
University of Dublin, Trinity College	Health Research Board, Ireland, St Vincent's University Hospital, Ireland, St. James's Hospital, Ireland, Tallaght University Hospital

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cardiorespiratory Fitness from Baseline	Cardiorespiratory fitness will be determined by Cardiopulmonary Exercise Test (CPET)	Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Secondary	Physical Performance	Physical Performance will be measured with the Short Physical Performance Battery (SPPB)	Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Secondary	Lower Limb Muscle Strength	Lower limb muscle strength (llbs)will be measured by a leg press 1-RM	Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Secondary	Hand Grip Strength	Hand grip strength (kg) will be measured with hand held dynamometry	Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Secondary	Physical Activity	Physical Activity levels will be measured by accelerometry (ACTIGRAPH GT3X+)	Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Secondary	Body Mass Index	Body mass index will be measured as the ratio of weight (kg) to height in metres squared.	Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Secondary	Waist Circumference	Waist circumference (cm) will be measured at the mid-point between the iliac crest and the 12th rib following gentle expiration.	Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Secondary	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.	Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Secondary	Fat Mass	Fat mass(kg) will be measured with the Seca mBCA 515.	Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Secondary	Fat Free Mass	Fat free mass (kg) will be measured with the Seca mBCA 515.	Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Secondary	Skeletal Muscle Mass	Skeletal muscle mass(kg) will be measured with the Seca mBCA 515.	Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Secondary	Dietary Quality	Dietary quality will be scored using the WCRF/AICR index which determines adherence to healthy eating guidelines for cancer survivors.	Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Secondary	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.	Baseline (T0), Immediately after the program intervention (T1), Three month Follow-up (T2), One-year post intervention (T3)
Secondary	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.	Baseline (T0), Immediately after the program intervention (T1), Three month Follow-up (T2), One-year post intervention (T3)
Secondary	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.	Baseline (T0), Immediately after the program intervention (T1), Three month Follow-up (T2), One-year post intervention (T3)
Secondary	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.	Baseline (T0), Immediately after the program intervention (T1), Three month Follow-up (T2), One-year post intervention (T3)
Secondary	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.	Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Secondary	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.	Immediately after the program intervention and Three-months post intervention
Secondary	Cost Analysis	The costs of the program will be set against the effects on HRQOL	Up to 1 year post program completion
Secondary	Bio-sample Collection	Serum and Plasma samples will be collected at each time-point to establish a survivorship Biobank for UGI cancer.	Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)