Colon CancerNCT04731441
Exercise Intervention Prior to CRS-HIPEC: Feasibility & Impact
A study testing Home-based Exercise Program Prior to CRS-HIPEC and Exercise Education in people with Colon Cancer and Ovarian Cancer, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
Our objective is to initiate an exercise program for patients with advanced GI or Gyn cancer, as prehabilitation prior to surgery. The objective of the prehabilitation program is to reduce complication rates and improve the length and quality of survival for patients with abdominal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Ovarian Cancer, GI Cancer
- What is being tested?
- Home-based Exercise Program Prior to CRS-HIPEC and Exercise Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2021to 1 Dec 2023
- 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 with peritoneal metastasis from appendix, colon, small bowel, endometrium, ovary or any other GI or Gyn primary tumor
- Patients should be eligible for and consent to surgery with the intention of performing CRS / HIPEC at Penn State Hershey Medical Center. Eligibility for CRS/HIPEC is a clinical determination based on a combination of factors including radiographic extent of disease, tumor histology and medical fitness for surgery
- Subjects who are explored but found to be unresectable will be included.
- Male or female.
- Patients should be age 18 or above.
- Surgery is planned for not less than 6 weeks and no more than 10 weeks from consultation
Who cannot join
- Patients who do not consent to surgery.
- Patients who require urgent surgery, sooner than 6 weeks
- Patients receiving neoadjuvant chemotherapy, with no surgical date planned before 10 weeks from consultation. These patients can be enrolled at the time of the follow-up visit, as long as they meet above criteria
- Patients not fluent in English
- Pregnant women
- Prisoners
- Patients with Cognitive Impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Our objective is to initiate an exercise program for patients with advanced GI or Gyn cancer, as prehabilitation prior to surgery. The objective of the prehabilitation program is to reduce complication rates and improve the length and quality of survival for patients with abdominal cancer. The prehabilitation program will be offered to patients who are eligible for and consent to cytoreductive surgery (CRS) and heated intraperitoneal chemotherapy (HIPEC)
Read the detailed description
Our objective is to assess the feasibility and impact of implementing an exercise program for patients with advanced GI or Gyn cancer, as prehabilitation prior to surgery. The objective of the prehabilitation program is to reduce complication rates and improve the length and quality of survival for patients with abdominal cancer. The prehabilitation program will be offered to patients who are eligible for and consent to cytoreductive surgery (CRS) and heated intraperitoneal chemotherapy (HIPEC).
- Conditions
- Colon Cancer, Ovarian Cancer, GI Cancer, Gynecologic Cancer
- Being tested
- Home-based Exercise Program Prior to CRS-HIPEC, Exercise Education
- Keywords
- HIPEC, CRS, Prehabilitation, Exercise
- Medical subject headings
- Colonic Neoplasms, Ovarian Neoplasms, Gastrointestinal Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based Exercise Program Prior to CRS-HIPECBehavioural
Exercise Program Subjects randomized to the intervention arm should have 6 weeks of home exercise prior to surgery, with a minimum of 5 weeks and not more than 7 weeks. The program will begin with an exercise consultation appointment with a certified fitness professional. During this consultation participants will receive an exercise manual for individualized home-based exercise and a practical introduction by an exercise and cancer specialist. PowerBlock adjustable dumbbells will be used for resistance training exercises and walking or jogging will be the primary type of aerobic training. The current program design was developed and successfully used with women with breast cancer. Thus, some components may need modification for this group of patients with advanced GI cancer.
Exercise EducationBehavioural
Control arm: Subjects randomized to the control arm will receive education and a handbook on the benefits of exercise and will be encouraged to have adequate protein in their diet and provided with the list of high protein foods and nutritional information. These subjects will undergo the same assessments as the intervention arm at all time points. Control subjects will be offered a 6-week home exercise program 3 months after CRS/HIPEC, as described in sections 7.2.1-7.2.3. Results and outcomes will not be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Exercise Program Subjects randomized to the intervention arm should have 6 weeks of home exercise prior to surgery, with a minimum of 5 weeks and not more than 7 weeks. The program will begin with an exercise consultation appointment with a certified fitness professional. During this consultation participants will receive an exercise manual for individualized home-based exercise and a practical introduction by an exercise and cancer specialist. PowerBlock adjustable dumbbells will be used for resistance training exercises and walking or jogging will be the primary type of aerobic training. The current program design was developed and successfully used with women with breast cancer. Thus, some components may need modification for this group of patients with advanced GI cancer. Receives: Behavioral: Home-based Exercise Program Prior to CRS-HIPEC |
| Education Group | Active comparator | Subjects randomized to the control arm will receive education and a handbook on the benefits of exercise and will be encouraged to have adequate protein in their diet and provided with the list of high protein foods and nutritional information. These subjects will undergo the same assessments as the intervention arm at all time points. Control subjects will be offered a 6-week home exercise program 3 months after CRS/HIPEC. Results and outcomes will not be recorded. Receives: Behavioral: Exercise Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Rate of enrollment into this trial
Measured: 1 year
Feasibility of doing exercises
The percent of exercises completed by subjects
Measured: 2 months
Secondary outcomes (2)
30-day Complication
- To assess the 30-day rate of complications after prehabilitation and CRS/HIPEC. The rate of complication after CRS/HIPEC is well described in the literature and established in our patient population at Penn State Cancer Institute. Infectious and non-infectious complications and length of stay will be collected
Measured: 1 month
Quality of Life after CRS-HIPEC
- To monitor quality of life after prehabilitation and CRS/HIPEC. Quality of life (QOL) after CRS/HIPEC is well described in the literature and was assessed in our patients in a pilot study that is nearly completed. Patient-Reported Outcomes Measurement Information System (PROMIS) T-Scores for Physical Function will be obtained, scores ranging from 20-80, with higher scores reflecting higher physical function.
To assess the effects of prehabilitation and CRS/HIPEC on muscle mass. Muscle mass at the level of L3 on cross-sectional imaging will be measured for all subjects at baseline, to determine the presence of sarcopenia. Muscle mass will be measured again after CRS/HIPEC. Changes in muscle mass after CRS/HIPEC are unknown, and the effect of a prehabilitation program in this patient population are also unknown. The results will serve as preliminary data for a future, larger study in this population with more specific hypotheses.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start18 Mar 2021
- Primary completion14 Oct 2023
- Study completion1 Dec 2023
Why it stopped: Difficulty enrolling and we lost exercise specialist
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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
- Subjects will be partially randomized to 1 of 2 treatment arms. Sarcopenia will be measured at baseline but is not a criterion for enrollment. Sarcopenic patients will all be in the intervention arm and receive the prehab exercise program. Non-sarcopenic patients will be randomized to the intervention arm or the control arm. The allocation scheme for non-sarcopenic subjects will be made with a computerized random number generator. This will take place the day of consent and subjects will be notified in person by the research assistant before the end of their visit with the surgeon. After randomization, subjects will proceed with a baseline assessment to obtain basic demographics, muscle strength, endurance performance, physical functioning, and physical activity. The subject will then proceed with 6 weeks of participating in the control or intervention arm, followed by surgery and a post-operative assessment. After the post-operative assessment, study is complete.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colette Pameijer, Milton S. Hershey Medical Center
- Investigators
- Colette R Pameijer, MD, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731441
- Sponsor's protocol ID
- STUDY00015358
- Status last verified
- Apr 2024
- First submitted
- 15 Jan 2021
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Non-applicable
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Intervention Prior to CRS-HIPEC: Feasibility & Impact
- ClinicalTrials.gov ID
- NCT04731441
- Acronym / sponsor ID
- STUDY00015358
- Conditions
- Colon Cancer, Ovarian Cancer, GI Cancer, Gynecologic Cancer
- Keywords
- HIPEC, CRS, Prehabilitation, Exercise
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty enrolling and we lost exercise specialist
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 14 Oct 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 1 Feb 2021 (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.
Our objective is to initiate an exercise program for patients with advanced GI or Gyn cancer, as prehabilitation prior to surgery. The objective of the prehabilitation program is to reduce complication rates and improve the length and quality of survival for patients with abdominal cancer. The prehabilitation program will be offered to patients who are eligible for and consent to cytoreductive surgery (CRS) and heated intraperitoneal chemotherapy (HIPEC)
Detailed description
Our objective is to assess the feasibility and impact of implementing an exercise program for patients with advanced GI or Gyn cancer, as prehabilitation prior to surgery. The objective of the prehabilitation program is to reduce complication rates and improve the length and quality of survival for patients with abdominal cancer. The prehabilitation program will be offered to patients who are eligible for and consent to cytoreductive surgery (CRS) and heated intraperitoneal chemotherapy (HIPEC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be partially randomized to 1 of 2 treatment arms. Sarcopenia will be measured at baseline but is not a criterion for enrollment. Sarcopenic patients will all be in the intervention arm and receive the prehab exercise program. Non-sarcopenic patients will be randomized to the intervention arm or the control arm. The allocation scheme for non-sarcopenic subjects will be made with a computerized random number generator. This will take place the day of consent and subjects will be notified in person by the research assistant before the end of their visit with the surgeon. After randomization, subjects will proceed with a baseline assessment to obtain basic demographics, muscle strength, endurance performance, physical functioning, and physical activity. The subject will then proceed with 6 weeks of participating in the control or intervention arm, followed by surgery and a post-operative assessment. After the post-operative assessment, study is complete.
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Behavioral: Home-based Exercise Program Prior to CRS-HIPECExercise Program Subjects randomized to the intervention arm should have 6 weeks of home exercise prior to surgery, with a minimum of 5 weeks and not more than 7 weeks. The program will begin with an exercise consultation appointment with a certified fitness professional. During this consultation participants will receive an exercise manual for individualized home-based exercise and a practical introduction by an exercise and cancer specialist. PowerBlock adjustable dumbbells will be used for resistance training exercises and walking or jogging will be the primary type of aerobic training. The current program design was developed and successfully used with women with breast cancer. Thus, some components may need modification for this group of patients with advanced GI cancer. |
| Education Group | Active comparator | Behavioral: Exercise EducationSubjects randomized to the control arm will receive education and a handbook on the benefits of exercise and will be encouraged to have adequate protein in their diet and provided with the list of high protein foods and nutritional information. These subjects will undergo the same assessments as the intervention arm at all time points. Control subjects will be offered a 6-week home exercise program 3 months after CRS/HIPEC. Results and outcomes will not be recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with peritoneal metastasis from appendix, colon, small bowel, endometrium, ovary or any other GI or Gyn primary tumor
- Patients should be eligible for and consent to surgery with the intention of performing CRS / HIPEC at Penn State Hershey Medical Center. Eligibility for CRS/HIPEC is a clinical determination based on a combination of factors including radiographic extent of disease, tumor histology and medical fitness for surgery
- Subjects who are explored but found to be unresectable will be included.
- Male or female.
- Patients should be age 18 or above.
Key exclusion criteria (7 listed)
- Patients who do not consent to surgery.
- Patients who require urgent surgery, sooner than 6 weeks
- Patients receiving neoadjuvant chemotherapy, with no surgical date planned before 10 weeks from consultation. These patients can be enrolled at the time of the follow-up visit, as long as they meet above criteria
- Patients not fluent in English
- Pregnant women
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 |
|---|---|---|
| Home-based Exercise Program Prior to CRS-HIPECExercise Program Subjects randomized to the intervention arm should have 6 weeks of home exercise prior to surgery, with a minimum of 5 weeks and not more than 7 weeks. The program will begin with an exercise consultation appointment with a certified fitness professional. During this consultation participants will receive an exercise manual for individualized home-based exercise and a practical introduction by an exercise and cancer specialist. PowerBlock adjustable dumbbells will be used for resistance training exercises and walking or jogging will be the primary type of aerobic training. The current program design was developed and successfully used with women with breast cancer. Thus, some components may need modification for this group of patients with advanced GI cancer. | Behavioural | Exercise Group |
| Exercise EducationControl arm: Subjects randomized to the control arm will receive education and a handbook on the benefits of exercise and will be encouraged to have adequate protein in their diet and provided with the list of high protein foods and nutritional information. These subjects will undergo the same assessments as the intervention arm at all time points. Control subjects will be offered a 6-week home exercise program 3 months after CRS/HIPEC, as described in sections 7.2.1-7.2.3. Results and outcomes will not be recorded. | Behavioural | Education Group |
Primary outcome
Acceptability
Time frame: 1 year
Rate of enrollment into this trial
Feasibility of doing exercises
Time frame: 2 months
The percent of exercises completed by subjects
2 secondary outcomes
30-day Complication
Time frame: 1 month
Quality of Life after CRS-HIPEC
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Difficulty enrolling and we lost exercise specialist). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No. Non-applicable
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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.
Colette R Pameijer, MD principal investigator
Penn State College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based Exercise Program Prior to CRS-HIPEC and Exercise Education in people with Colon Cancer and Ovarian Cancer, run by Milton S. Hershey Medical Center at 1 site in United States.
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 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: stopped early, as of the sponsor's last update on 17 Apr 2024. 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 United States. 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 was stopped early (reason given: Difficulty enrolling and we lost exercise specialist). 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?
Acceptability (time frame: 1 year). The study lists 2 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 17 Apr 2024.