Peritoneal MalignancyPANONCT05305820
Perioperative Exercise and Nutritional Optimisation Prehabilitation Before Surgery for Patients With Peritoneal Malignancy
A study testing Exercise and Nutrition in people with Peritoneal Malignancy and Ovarian Cancer, run by Dublin City University at 3 sites in Ireland.
Trial summary
People who are diagnosed with cancer of the colon/rectum/appendix/ovaries that spreads into the lining of the tummy and some ovarian cancers or people with pseudomyxoma peritonei can often undergo intensive treatment including major surgery where chemotherapy is given whilst the person is having surgery - also known… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Malignancy, Ovarian Cancer, Rectum Cancer
- What is being tested?
- Exercise and Nutrition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesIreland
- Study dates
- 1 Sep 2022to 1 Aug 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
- age ≥18 years,
- multidisciplinary team referral for CRS-HIPEC for colorectal/appendix/ovarian peritoneal disease or pseudomyxoma peritonei (+/- completed neoadjuvant cancer treatment)
- WHO performance status ≤2.
Who cannot join
- inability to provide informed consent,
- impaired cognitive function with a reduced ability to either understand advice /instructions from or communicate with the research team,
- declined surgery,
- surgery in less than 2 weeks
- pregnancy or breastfeeding,
- inability to participate in the exercise training (unable to perform the 6 Minute Walk Test)
- absolute contraindications to exercise testing, veganism.
Trial locations and contacts
3 sites in 1 country.
Ireland3 sites
Dublin City University
Dublin
Mater Misericordiae university hospital
Dublin
Royal College of Surgeons , Ireland
Dublin
About this study
Official title: The PANO Trial: Perioperative Exercise and Nutrition Optimisation Prehabilitation in Cancer Patients With Peritoneal Malignancy
People who are diagnosed with cancer of the colon/rectum/appendix/ovaries that spreads into the lining of the tummy and some ovarian cancers or people with pseudomyxoma peritonei can often undergo intensive treatment including major surgery where chemotherapy is given whilst the person is having surgery - also known by doctors as surgery and hyperthermic intraperitoneal chemotherapy (HIPEC). Fitness for this surgery can improve if people undertake a prehabilitation programme at the time they get their diagnosis. To date, little research has focused on how exercise and nutrition support before surgery can help these patients during recovery. The aim of this study is to explore the use of exercise and nutritional support pre-treatment to enhance physical and psychological outcomes for patients.
Read the detailed description
The comparator in this study will be standard oncological care. Control patients will receive the same care as standard without the addition of a formal exercise and nutrition support programme. The pre-treatment (prehabilitation) programme will commence following diagnosis and continue up to the point of surgery and recommence for six weeks following surgery when deemed clinically fit to participate. Assessments will occur at baseline, pre-surgery, post-surgery, and 6 weeks later and a follow up... Mixed methods will be employed with patients taking part in self-report assessments, physical assessments, and qualitative interviews. The primary aim of the study is to assess the feasibility of the intervention and cardiorespiratory fitness pre-surgery. The secondary aims include assessing the effect of the intervention on physical health, psychological wellbeing, health-related quality of life, self-efficacy, nutrition, and serology markers. Exploratory aims also include post-operative morbidity, health economics analysis and qualitative interview of patient experience.
- Being tested
- Exercise, Nutrition
- Keywords
- Peritoneal Malignancy
- Medical subject headings
- Ovarian Neoplasms, Rectal Neoplasms, Appendiceal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called Tailored Exercise Prehabilitation Program
Standard Exercise Program- Participants will be invited to take part in a structured home, supervised, or both, exercise program while undergoing treatment and for a six-week period when deemed fit post-surgery.
NutritionBehavioural
Also called Nutritional Optimisation
Participants will be screened for their nutritional health and tailored advice and education will be provided on an individualised basis. An online dietary recall tool will be used to track patients' dietary habits. This will occur from diagnosis until point of surgery and recommence for 6 weeks post-surgery once deemed physically fit.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Exercise: The exercise training program was designed to improve physical fitness prior to surgery and for a 6-week period after surgery once deemed fit.
Nutrition: The nutritional arm consists of nutritional intervention tailored to the outcome of the nutritional screening.Participants will be asked to take part in a dietary food recall system called Foodbook24, and based on their dietary needs will be supported in nutritional optimisation. Receives: Behavioral: Exercise; Behavioral: Nutrition |
| Control | No intervention | This group will receive standard oncological care and will receive no formal education of exercise or nutritional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Adherence to the Intervention
Prehabilitation fidelity in terms of the patient group adherence as measured by patient structured qualitative feedback and activity logs.
Measured: 2-6 weeks pre surgery, 6 weeks post-surgery
Feasibility of participant retention to the Intervention
Prehabilitation fidelity in terms of the patient group retention as measured by patient screening and retention logs and monitoring of recruitment rates.
Measured: 2-6 weeks pre-surgery, 6 weeks post-surgery
Feasibility of intervention effectiveness
Prehabilitation fidelity in terms of intervention effectiveness as measured by qualitative patient feedback at two timepoints. Monitoring of patient activity logs. Engagement with online and in-person exercise and nutritional intervention resources.
Measured: 2-6 weeks pre-surgery, 6 weeks post-surgery
Change in Cardiorespiratory Fitness
Cardiorespiratory fitness using the 6-Minute Walk Test (6MWT) assessed at the pre-surgery time point. The 6MWT is performed with participants walking up and down a 20 m course marked by cones for 6 min under instruction to cover as much ground as possible. The number of laps completed is recorded. A standard set of instructions is used as per the European Respiratory Society guidelines. The 6MWT is a validated assessment of cardiorespiratory function in clinical populations.
Measured: 2-6 weeks pre-surgery, 6 weeks post-surgery
Secondary outcomes (14)
Change in Strength - The Handgrip Test
This is 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 four fingers 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.
Measured: 2-6 weeks pre-surgery, 6 weeks post-surgery
Change in Strength - The Stand to Sit 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.
Measured: 2-6 weeks pre-surgery, 6 weeks post-surgery
Change in Activity - 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.
Measured: 2-6 weeks pre-surgery, 6 weeks post-surgery
Change in Psychological Stress
NCCN Distress Thermometer: To detect distress (psychosocial stress) with all stages of cancer. This is measured using a visual analogue scale like a thermometer to indicate a range from 0 (not loaded) to 10 (extreme pressure). Additional 36 items in five problem areas - practical family, emotional, spiritual, physical, are rated for distress and a score of 5 or higher is considered significant stress.
Measured: 2-6 weeks pre-surgery, 6 weeks post-surgery
Change in Psychological Stress- Impact of Events Scale
This is a self-report measure of traumatic stress symptoms focused on intrusive thoughts and avoidant behaviours. Questions will be adapted to reflect the PM diagnosis specifically. Frequency of symptoms will be self-reported during the previous week using a 4 point scale from 0 (not at all) to 5 (often). Total scores range from 0 to 75 with higher scores indicative of greater cancer-related stress. Scores in the range of > 30 are reflective of clinically significant stress. Higher scores on an adapted IES are related to decreased immune function in breast cancer patients.
Measured: 2-6 weeks pre-surgery, 6 weeks post surgery
Change in Cognitive Reserve-Cognitive Reserve Index (CR-IQ)
This questionnaire is a semi-structured interview with the patients that measures reserve in three parts: Education; Working-Activity, and Leisure time. Each sub-scale and total index score is correlated with age and expressed on a standardised scale.
Measured: 2-6 weeks pre-surgery, 6 weeks post surgery
Change in Cognition- FACT-Cog
The Functional Assessment of Cancer Therapy- Cognition is a self-report 37 item questionnaire that assesses cancer related cognitive problems. Sub-scales include: Perceived cognitive impairments, impact of perceived cognitive impairments on QoL, Comments from others and perceived cognitive abilities.
Measured: 2-6 weeks pre-surgery, 6 weeks post surgery
Change in Self-Efficacy
This is a 12 item Communication and Attitudinal Self-Efficacy scale for Cancer, and rates a patients' perceived ability to seek information, understand and engage in care, and maintain a positive attitude. Confidence level for each skill is rated on a 4 point scale with higher score indicative of higher self-efficacy.
Measured: 2-6 weeks pre-surgery, 6 weeks post surgery
Change in Health Related Quality of Life (HrQoL)-EQ-5D-5L (5L)
This is a standardised and validated self-report measure describing health status. It is disease non-specific but applicable to cancer, with five dimensions (mobility, self-care, typical activities, pain, anxiety/depression) with three problem levels to rate (some to extremely problematic). The higher the index score, the higher the perceived health status.
Measured: 2-6 weeks pre-surgery, 6 weeks post surgery
Change in Health Related Quality of Life (HrQoL)- FACT-G
This is a version of the Functional Assessment of Cancer Therapy is a 28-item self-report survey that measures quality of life; it has 5 sub-scales measures physical well-being (PWB), functional wellbeing (FWB), social/family wellbeing (SFWB), emotional wellbeing (EWB) and satisfaction with care. Self-ratings of all 5 subscales for the present moment and the preceding week are captured, computing an overall total score. Good Cronbach's for all five have been reported, and the higher the core the better the QoL.
Measured: 2-6 weeks surgery, 6 weeks post surgery
Change in Nutritional Status-The Malnutrition Screening Tool
The Malnutrition Screening Tool (MST) is an easy to administer tool. It is based on recent appetite and weight loss and has been previously validated for use with oncology patients. The measure scores both "recent intake" and "recent weight loss". A total score of >2 indicates a risk of malnutrition.
Measured: 2-6 weeks pre-surgery, 6 weeks post surgery
Change in Nutritional Status- Glasgow Prognostic Score
This measure of cancer prognosis is measured using serum markers CRP and Albumin. The score is used to measure the cancer prognosis. The score ranges from 0-2, with patients with a normal measure of CRP assigned a score of zero, and those with both elevated or reduced levels a score of 2.
Measured: 2-6 weeks pre-surgery, 6 weeks post surgery
Change in Dietary Intake - Foodbook24
Foodbook24 is a Web-based, dietary tool consisting of a 24-hour dietary recall and food frequency questionnaire. Patients will provide dietary recall information about what they have eaten in the past 24 hours.
Measured: 2-6 weeks pre-surgery, 6 weeks post surgery
Change in Nutritional Status- Blood Screening
Bloods should be ordered by clinician for Iron (Fe) analysis (identify anaemia) and CT scans of patients should be analysed for the identification of incidence of sarcopenia.
Measured: 2-6 weeks pre-surgery, 6 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Sep 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal MalignancyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group randomised 1:1 controlled multi-centre trial
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dublin City University
- Sponsor type
- University, hospital or other
- Collaborators
- Mater Misericordiae University Hospital, Royal College of Surgeons, Ireland
- Responsible party
- Principal investigator, Aideen Scriney, Dublin City University
- Investigators
- Jurgen Mulsow, Mr., Principal investigator, Mater Misericordiae University HospitalLisa Loughney, Dr., Principal investigator, Royal College of Surgeons, IrelandLorraine Boran, Dr., Principal investigator, Dublin City University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305820
- Sponsor's protocol ID
- COALESE/2021/103
- Other IDs
- COALESE/2021/103
- Acronym
- PANO
- Status last verified
- Mar 2024
- First submitted
- 15 Feb 2022
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PANO Trial: Perioperative Exercise and Nutrition Optimisation Prehabilitation in Cancer Patients With Peritoneal Malignancy
- ClinicalTrials.gov ID
- NCT05305820
- Acronym / sponsor ID
- PANO / COALESE/2021/103
- Keywords
- Peritoneal Malignancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Dublin City UniversityUniversity, hospital or other
- Collaborators
- Mater Misericordiae University Hospital, Royal College of Surgeons, Ireland
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 31 Mar 2022 (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.
People who are diagnosed with cancer of the colon/rectum/appendix/ovaries that spreads into the lining of the tummy and some ovarian cancers or people with pseudomyxoma peritonei can often undergo intensive treatment including major surgery where chemotherapy is given whilst the person is having surgery - also known by doctors as surgery and hyperthermic intraperitoneal chemotherapy (HIPEC). Fitness for this surgery can improve if people undertake a prehabilitation programme at the time they get their diagnosis. To date, little research has focused on how exercise and nutrition support before surgery can help these patients during recovery. The aim of this study is to explore the use of exercise and nutritional support pre-treatment to enhance physical and psychological outcomes for patients.
Detailed description
The comparator in this study will be standard oncological care. Control patients will receive the same care as standard without the addition of a formal exercise and nutrition support programme. The pre-treatment (prehabilitation) programme will commence following diagnosis and continue up to the point of surgery and recommence for six weeks following surgery when deemed clinically fit to participate. Assessments will occur at baseline, pre-surgery, post-surgery, and 6 weeks later and a follow up... Mixed methods will be employed with patients taking part in self-report assessments, physical assessments, and qualitative interviews. The primary aim of the study is to assess the feasibility of the intervention and cardiorespiratory fitness pre-surgery. The secondary aims include assessing the effect of the intervention on physical health, psychological wellbeing, health-related quality of life, self-efficacy, nutrition, and serology markers. Exploratory aims also include post-operative morbidity, health economics analysis and qualitative interview of patient experience.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel group randomised 1:1 controlled multi-centre trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Exercise, Behavioral: NutritionExercise: The exercise training program was designed to improve physical fitness prior to surgery and for a 6-week period after surgery once deemed fit. Nutrition: The nutritional arm consists of nutritional intervention tailored to the outcome of the nutritional screening.Participants will be asked to take part in a dietary food recall system called Foodbook24, and based on their dietary needs will be supported in nutritional optimisation. |
| Control | No intervention | –This group will receive standard oncological care and will receive no formal education of exercise or nutritional intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥18 years,
- multidisciplinary team referral for CRS-HIPEC for colorectal/appendix/ovarian peritoneal disease or pseudomyxoma peritonei (+/- completed neoadjuvant cancer treatment)
- WHO performance status ≤2.
Key exclusion criteria (7 listed)
- inability to provide informed consent,
- impaired cognitive function with a reduced ability to either understand advice /instructions from or communicate with the research team,
- declined surgery,
- surgery in less than 2 weeks
- pregnancy or breastfeeding,
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 |
|---|---|---|
| ExerciseAlso: Tailored Exercise Prehabilitation ProgramStandard Exercise Program- Participants will be invited to take part in a structured home, supervised, or both, exercise program while undergoing treatment and for a six-week period when deemed fit post-surgery. | Behavioural | Intervention |
| NutritionAlso: Nutritional OptimisationParticipants will be screened for their nutritional health and tailored advice and education will be provided on an individualised basis. An online dietary recall tool will be used to track patients' dietary habits. This will occur from diagnosis until point of surgery and recommence for 6 weeks post-surgery once deemed physically fit. | Behavioural | Intervention |
Primary outcome
Feasibility of Adherence to the Intervention
Time frame: 2-6 weeks pre surgery, 6 weeks post-surgery
Prehabilitation fidelity in terms of the patient group adherence as measured by patient structured qualitative feedback and activity logs.
Feasibility of participant retention to the Intervention
Time frame: 2-6 weeks pre-surgery, 6 weeks post-surgery
Prehabilitation fidelity in terms of the patient group retention as measured by patient screening and retention logs and monitoring of recruitment rates.
Feasibility of intervention effectiveness
Time frame: 2-6 weeks pre-surgery, 6 weeks post-surgery
Prehabilitation fidelity in terms of intervention effectiveness as measured by qualitative patient feedback at two timepoints. Monitoring of patient activity logs. Engagement with online and in-person exercise and nutritional intervention resources.
Change in Cardiorespiratory Fitness
Time frame: 2-6 weeks pre-surgery, 6 weeks post-surgery
Cardiorespiratory fitness using the 6-Minute Walk Test (6MWT) assessed at the pre-surgery time point. The 6MWT is performed with participants walking up and down a 20 m course marked by cones for 6 min under instruction to cover as much ground as possible. The number of laps completed is recorded. A standard set of instructions is used as per the European Respiratory Society guidelines. The 6MWT is a validated assessment of cardiorespiratory function in clinical populations.
14 secondary outcomes
Change in Strength - The Handgrip Test
Time frame: 2-6 weeks pre-surgery, 6 weeks post-surgery
Change in Strength - The Stand to Sit Test
Time frame: 2-6 weeks pre-surgery, 6 weeks post-surgery
Change in Activity - 3-day ActivPAL3 triaxial accelerometer
Time frame: 2-6 weeks pre-surgery, 6 weeks post-surgery
Change in Psychological Stress
Time frame: 2-6 weeks pre-surgery, 6 weeks post-surgery
Change in Psychological Stress- Impact of Events Scale
Time frame: 2-6 weeks pre-surgery, 6 weeks post surgery
Change in Cognitive Reserve-Cognitive Reserve Index (CR-IQ)
Time frame: 2-6 weeks pre-surgery, 6 weeks post surgery
Change in Cognition- FACT-Cog
Time frame: 2-6 weeks pre-surgery, 6 weeks post surgery
Change in Self-Efficacy
Time frame: 2-6 weeks pre-surgery, 6 weeks post surgery
Change in Health Related Quality of Life (HrQoL)-EQ-5D-5L (5L)
Time frame: 2-6 weeks pre-surgery, 6 weeks post surgery
Change in Health Related Quality of Life (HrQoL)- FACT-G
Time frame: 2-6 weeks surgery, 6 weeks post surgery
Change in Nutritional Status-The Malnutrition Screening Tool
Time frame: 2-6 weeks pre-surgery, 6 weeks post surgery
Change in Nutritional Status- Glasgow Prognostic Score
Time frame: 2-6 weeks pre-surgery, 6 weeks post surgery
Change in Dietary Intake - Foodbook24
Time frame: 2-6 weeks pre-surgery, 6 weeks post surgery
Change in Nutritional Status- Blood Screening
Time frame: 2-6 weeks pre-surgery, 6 weeks post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
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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.
Jurgen Mulsow, Mr. principal investigator
Mater Misericordiae University Hospital
Lisa Loughney, Dr. principal investigator
Royal College of Surgeons, Ireland
Lorraine Boran, Dr. principal investigator
Dublin City University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Nutrition in people with Peritoneal Malignancy and Ovarian Cancer, run by Dublin City University at 3 sites 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 3 inclusion and 7 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 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Feasibility of Adherence to the Intervention (time frame: 2-6 weeks pre surgery, 6 weeks post-surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2024.