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Exercise InterventionPERIOP-OGNCT03807518

Pre- and Post-Operative Exercise Program in Upper Gastrointestinal Cancers

A study testing Standard Exercise Program in people with Exercise Intervention, run by Royal College of Surgeons, Ireland at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Esophageal and gastric cancers are a considerable health burden. In the past 10 years the 5-year survival for both cancers has doubled. This is due to a number of factors including advances in neo adjuvant and adjuvant chemotherapy and radiotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Exercise Intervention
What is being tested?
Standard Exercise Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteIreland
Study dates
1 Mar 2019to 1 Mar 2021
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

  • Be 18 years of age or above;
  • Have confirmed Multi Disciplinary Team (MDT) evidence of adenocarcinoma or squamous cell cancer of the oesophagus, oesophago- gastric junction or stomach requiring neoadjuvant therapy and planned curative resection.
  • Be referred by a multidisciplinary team meeting for neo adjuvant chemotherapy or neo adjuvant chemoradiotherapy prior to planned oesophagectomy or gastrectomy.
  • Have measurement confirming (endoscopic or otherwise) that the tumour starts more than 5cm below cricopharyngeus;
  • Be fit for pre-operative anaesthesia and surgery
  • Be able to provide written informed consent.

Who cannot join

  • Inability to participate in the exercise program (unable to perform 6 Minute Walk Test, unable to attend for assessment of parameters at any time point).
  • Patients with high grade dysplasia (squamous cell or adenocarcinoma);
  • Patients who have or develop metastatic disease at time of enrolment or during their neoadjuvant therapy;
  • Patients being referred for primary surgery without requirement for neoadjuvant treatment;
  • Patients with squamous cell cancer of the oesophagus who the MDT recommends or who individually elect to undergo definitive chemoradiotherapy;
  • Evidence of previous/concomitant malignancy that would interfere with this treatment protocol;
  • Pregnancy;
  • Patients participating in other trials that would interfere with the implementation of this protocol at a particular site.

Trial locations and contacts

1 site in 1 country.

Ireland1 site
  • Beaumont Hospital

    Dublin

Other trials in Ireland

About this study

Official title: The Effect of a Pre- and Post- Operative Exercise Programme Versus Standard Care on Physical Fitness in People With Upper Gastrointestinal Cancers- Study Protocol for a Randomised Control Trial: The PERIOP-OG Trial.

Esophageal and gastric cancers are a considerable health burden. In the past 10 years the 5-year survival for both cancers has doubled. This is due to a number of factors including advances in neo adjuvant and adjuvant chemotherapy and radiotherapy. However, physical fitness significantly declines as a result of neo adjuvant an adjuvant therapy. From studies in other cancers it is known that peri operative training improves physical fitness, yet there is little research into its effects in those with upper gastrointestinal cancers. The aim of this study is to assess the effect of a pre-and post operative training program on patients with upper gastrointestinal cancers on their physical fitness and consequently their optimism, quality of life and post operative morbidity.

Read the detailed description

The comparator in this study will be standard oncological care. There patients will receive the exact same care as the intervention group patients but will receive no exercise training program.

The primary goal of this multi-centre randomised controlled trial are to investigate the effects of peri-operative exercise training programmes on physical fitness, measured with a 6 minute walk test, in patients undergoing a major curative upper-GI resection for either oesophageal or gastric cancer.

The secondary aims will look at the effect of peri-operative exercise training on patients quality of life, optimism and well being, post operative morbidity, nutritional status and blood markers of inflammation.

Being tested
Standard Exercise Program
Keywords
Oesophageal Cancer, Gastric Cancer, Physical Fitness
Medical subject headings
Esophageal Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard Exercise ProgramBehavioural

    Standard Exercise Program- Participants will be invited to take part in a structured home, supervised, or both, exercise program while undergoing neo adjuvant therapy and for a six week period when deemed fit post surgery.

Study groups in NCT03807518
Study groupRoleWhat they receive
Structured Exercise InterventionExperimentalThe exercise training program was designed to improve physical fitness while the patients are receiving neoadjuvant treatment prior to surgery and for a 6 week period after surgery once patients are deemed fit to return to training.
Receives: Behavioral: Standard Exercise Program
Standard Oncological CareNo interventionThis group will receive standard oncological care and will receive no formal education of exercise intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Physical Fitness

    The primary goal of this multi-centre randomised controlled trial is to investigate the effects of peri-operative exercise training programmes on physical fitness, defined as the distance covered in metres and centimetres during a 6 minute walk test, in patients undergoing a major curative upper-GI resection for either oesophageal or gastric cancer. To complete the Six Minute Walk Test, no warm up is permitted and participants rest in a seated position for 10 minutes prior to the test beginning. Participants walk up and down a 20m course marked by cones for 6 minutes under instruction to cover as much ground as possible. The number of laps completed is recorded. A standard set of instructions as well as encouragement is used. After 6 minutes, the participant stops and the distance covered in the final partial lap as measured and total distance covered is calculated. Change from baseline to post treatment difference between groups.

    Measured: Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery

Secondary outcomes (19)
  1. Change in Strength - The Sit to Stand Test

    Strength will be measured using two tests. the Sit to Stand Test . Participants will sit on a chair (height 43-45 cm) with arms crossed on their, and legs flat on the floor, parallel to each other, and approximately shoulder width apart. Participants will stand up and sit down 10 times as quickly as possible. Participants must not bounce off the chair when moving from a seated position to standing position. They must fully extend their legs on each stand. The time taken to perform 10 repetitions will be timed using a stopwatch. Participants will perform two trials and the best trial will be recorded as their score. Change from baseline to post treatment difference between groups.

    Measured: Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery

  2. Change in Strength - The Handgrip Test

    Strength will be measured using a hand dynamometer. The test will be conducted in a standing position with the upper arm tight against the participant's trunk and the forearm at a right angle to the upper arm. If this is not possible the participant may sit in an upright chair or use their free hand to rest the dynamometer on a table to support the arm. The gripping handle will be set to a comfortable width to ensure the patient can rest the middle piece of the fourfingers on the handle. The participant will be instructed to squeeze the handle with maximum force for a few seconds. The value on the scale will be recorded. The participant will complete two trials on each hand. The highest score will be accepted.Change from baseline to post treatment difference between groups.

    Measured: Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery

  3. Change in Body Composition

    Determined by body mass index (BMI). BMI will be calculated as weight in kilograms divided by height in meters squared. Height will be measured using a wall stadiometer to the nearest .1cm. Weight will be measured using an electronic scales to the nearest .1kg.Change from baseline to post treatment difference between groups.

    Measured: Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery

  4. Change in Physical Activity - Accelerometer

    This will be measured using two assessments: 3-day ActivPAL3 triaxial accelerometer. Participants will be instructed to wear the device on the midpoint of the anterior aspect of the right thigh and attach using a film adhesive frame dressing. They will continue to wear this for three days continuously. They cannot wear the ActivPAL3 triaxial accelerometer during water activity periods. Change from baseline to post treatment difference between groups.

    Measured: Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery

  5. Change in Quality of Life measured using the EQ-5D Health Questionnaire

    EQ-5D (Euro qual health questionnaire consists of 5 themes graded 1-5 and an overall score. The questionnaire is then converted to an index value using the Crosswalk value sets developed for the EQ-5D Health Questionnaire.

    There is a descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.

    The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine.

    Measured: Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery

  6. Change in Optimism

    Optimism as an outcome is measured using the Life Orientation Test-Revised (LOT-R: Scheier, Carver, \& Bridges, 1994) and consists of ten items assessing generalised expectancies for positive versus negative outcomes. This will be administered at baseline and pre-surgery only. The scale uses 10 questions on a 1-10. There are 4 filler questions. High scores indicate optimism.

    Measured: Baseline, Change from baseline to one week before surgery

  7. Change in Well Being-The Functional Assessment of Cancer Therapy (FACT-E) questionnaire.

    Functional Assessment of Cancer Therapy-Esophageal (FACT-E) questionnaire. This is an HRQOL instrument validated in patients with esophageal cancer. It is composed of a general component (FACT-G) and an esophageal cancer subscale (ECS). Patients will score a series of questions (0 = not at all; 4 = very much) in five sections (physical well-being; social/family well-being; emotional well-being; functional well-being; additional concerns) for the past 7 days. Higher scores will suggest better quality of life.

    Measured: Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery

  8. Well Being - Semi-structured Interviews.

    Semi-structured interviews will explore patients' perceptions of the surgical pathway. This will be analysed from interview transcripts through qualitative analysis using thematic content analysis.

    Measured: One week before surgery

  9. Change in Well Being - Self-efficacy (General Self Efficacy Scale)

    Self reported measure of Self-efficacy (General Self Efficacy Scale). 10 item questionnaire.Scored 1-4. 1 being "not at all true", 4 being "Exactly True". The total score is calculated by finding the sum of the all items. For the GSE, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.

    Measured: Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery

  10. Change in Well Being - Mastery (Pearlin Mastery Scale).

    Mastery (Pearlin Mastery Scale). This consists of seven items designed to assess one aspect of psychological coping resources (Mastery). Example items include, "Sometimes I feel that I am being pushed here and there in life" (reverse-scored) and "What happens to me in the future mostly depends on me." Response options range from 1, strongly disagree, to 7, strongly agree. Score range from 7-28. Higher scores indicate greater mastery.

    Measured: Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery

  11. Fear of Surgery Questionnaire

    The fear of surgery questionnaire is a valid and reliable eight-item index of surgical fear consisting of two subscales: fear of the short-term consequences of surgery and fear of the long-term consequences. Scoring range 0-100 with 0 being not afraid at all and 100 indicating very afraid.

    Measured: One week before surgery

  12. Post Operative Morbidity - Post Operative Morbidity Score (POMS)

    Post-operative Morbidity Outcomes: Assessed using the Post-operative Morbidity Score (POMS) at day 15. The POMS is an 18-item tool that addresses morbidity relevant to the post-surgical patient. The subcategories are Pulmonary, Infectious, Renal, Gastrointestinal, Cardiovascular, Neurological, Hematological, Wound and Pain. It is implemented as the morbidity either being present or absent.

    Measured: Day 15 post surgery

  13. Post Operative Morbidity - Post Operative Morbidity Score (POMS)

    Post-operative Morbidity Outcomes: Assessed using the Post-operative Morbidity Score (POMS) at day 15. The POMS is an 18-item tool that addresses morbidity relevant to the post-surgical patient. The subcategories are Pulmonary, Infectious, Renal, Gastrointestinal, Cardiovascular, Neurological, Hematological, Wound and Pain. It is implemented as the morbidity either being present or absent.

    Measured: Day 30 post surgery

  14. Post Operative Morbidity -Clavien-Dindo Classification of Surgical Outcomes

    The Clavien-Dindo classification of surgical complications, this consists of 5 grades that rank a post operative complication. grade one being any deviation form the usual post operative course and grade 5 being death.

    Measured: Day 15 post surgery

  15. Post Operative Morbidity -Clavien-Dindo Classification of Surgical Outcomes

    The Clavien-Dindo classification of surgical complications, this consists of 5 grades that rank a post operative complication. grade one being any deviation form the usual post operative course and grade 5 being death.

    Measured: Day 30 post surgery

  16. Change in Nutritional Status -Assessed using Glasgow Prognostic Score

    The Glasgow Prognostic Score Provides cancer prognosis based on serum biomarkers CRP and Albumin. It is calculated as follows: a score of 0 for normal C reactive protein and albumin levels, score 1 for either an abnormal C reactive protein or abnormal albumin level and score 2 for both abnormal C reactive protein and abnormal albumin levels.

    Measured: Baseline, one week after completion of neo adjuvant treatment, one week before surgery,15 days after surgery, 30 days after surgery, six weeks after surgery, twelve weeks after surgery

  17. Change in Nutritional Status -Assessed using Foodbook 24

    Foodbook24 is a Web-based, dietary tool consisting of a 24- hour dietary recall and food frequency questionnaire alongside supplementary questionnaires.

    Measured: Baseline, one week after completion of neo adjuvant treatment, one week before surgery, 15 days after surgery, 30 days after surgery, weeks after surgery, twelve weeks after surgery

  18. Change in concentration of blood markers of Inflammation- C-Reactive Protein

    C-Reactive Protein will be assessed at each time point. A level greater that 15mmol/L

    Measured: Baseline, one week after completion of neo adjuvant treatment, one week before surgery, 15 days after surgery, 30 days after surgery, six weeks after surgery, twelve weeks after surgery

  19. Change in concentration of blood markers of Inflammation- White Cell Differential

    White Cell Differential will be assessed at each time point. Normal range 3.5-10.5 x 109/L

    Measured: Baseline, one week after completion of neo adjuvant treatment, one week before surgery, 15 days after surgery, 30 days after surgery, six weeks after surgery, twelve weeks after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2019
  2. Study start1 Mar 2019
  3. Primary completion19 Dec 2020
  4. Study completion1 Mar 2021

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel group randomised 1:1 controlled multi centre trial
Masking
Single blind
Who is masked
Investigator
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03807518
Sponsor's protocol ID
RCSI 18/58
Acronym
PERIOP-OG
Status last verified
May 2020
First submitted
17 Dec 2018
Last updated
9 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Loughney L, Bolger J, Tully R, Sorensen J, Bambrick M, Carroll PA, Arumugasamy M, Murphy TJ, McCaffrey N, Robb WB; PERIOP-OG Working Group. The effect of a pre-operative and post-operative exercise programme versus standard care on physical fitness of patients with oesophageal and gastric cancer undergoing neoadjuvant treatment prior to surgery (the PERIOP-OG trial): a randomized controlled trial. Int J Surg. 2024 Oct 1;110(10):6632-6646. doi: 10.1097/JS9.0000000000001663.

    PubMed 38935085
  • Tully R, Loughney L, Bolger J, Sorensen J, McAnena O, Collins CG, Carroll PA, Arumugasamy M, Murphy TJ, Robb WB; PERIOP OG Working Group. The effect of a pre- and post-operative exercise programme versus standard care on physical fitness of patients with oesophageal and gastric cancer undergoing neoadjuvant treatment prior to surgery (The PERIOP-OG Trial): Study protocol for a randomised controlled trial. Trials. 2020 Jul 13;21(1):638. doi: 10.1186/s13063-020-04311-4.

    PubMed 32660526

Questions about this trial

What is this clinical trial studying?

A study testing Standard Exercise Program in people with Exercise Intervention, run by Royal College of Surgeons, Ireland 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 9 Mar 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Physical Fitness (time frame: Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery). 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 NCT03807518, which also lists 2 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 9 Mar 2021.

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