Colorectal CancerNCT05854394
Effect of Multimodal Prehabilitation After Colorectal Cancer Surgery
A study testing Multimodal prehabilitation management Multimodal prehabilitation management in people with Colorectal Cancer, run by Xiamen University at 1 site in China.
Trial summary
The process of enhancing an individual's functional capacity to optimize physiologic reserves before an operation to withstand the stress of surgery has been coined prehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Multimodal prehabilitation management Multimodal prehabilitation management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 31 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- From 18 y/o to 75 y/o
- Suspected of colorectal cancer
- Decide to take the colorectal cancer radical surgery in The First Hospital Affiliated to Xiamen University
- Patients with post-operative pathological diagnosis of colorectal cancer
Who cannot join
- Refuse or fail to cooperate the study (due to any reason)
- Unable to tolerate prehabilitaion strategy (including exercise guide, whey protein and psycho-relaxation exercise)
- Other severe cardio-pulmonary diseases that would affect the 6MWD
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, FuJian Provice, 361000
JiaJun Zhang, Master of Medicine, +8618298370130, zjiajunmail@163.com
About this study
Official title: Effect of Multimodal Prehabilitation on Functional Recovery and Quality of Life After Colorectal Cancer Surgery
The process of enhancing an individual's functional capacity to optimize physiologic reserves before an operation to withstand the stress of surgery has been coined prehabilitation. This is a prospective randomized controlled trail, designed to explore if the patients who take Colorectal Cancer Surgery will benefit from short-term multimodal prehabilitation strategy. multimodal prehabilitation includes exercise, nutrition supplement and physiology management preoperatively. It starts from the day that patients decide to take the surgery until the day before surgery, lasting 1~2 week in The First Affiliated Hospital of Xiamen University. And investigators follow-up patients until 4 weeks after surgery to investigate if multimodal prehabilitation strategy can improve the postoperative functional recovery and improve the quality of life #reduce complications and improve prognosis.
Read the detailed description
The process of enhancing an individual's functional capacity to optimize physiologic reserves before an operation to withstand the stress of surgery has been coined prehabilitation. It has been confirm that trimodal prehabilitation strategy including exercise, diet and psychology guidance could improve postoperative functional recovery after surgery for patients undergoing colorectal resection. Although many clinical studies have confirmed that preoperative exercise for patients undergoing colorectal cancer surgery is safe and useful, but the prehabilitation strategy in previous studies usually takes 4~8 weeks. However, patient suspected of malignant tumor often wouldn't wait for such a long period. Investigators therefore designed this study to investigate if a 1~2 week multimodal prehabilitation strategy benefits the patients undergoing laparoscopic colorectal cancer resection. There will be 100 patients awaiting operation for primary colorectal cancer recruited in this research at The First Affiliated Hospital of Xiamen University.
After informed consent was obtained, the patients will be divided into two groups randomly, the prehibilitation group and control group.
The prehabilitation group will receive an individual trimodal prehabilitation strategy after a complete assessment, including physical exercise, nutritional optimization, and psychological therapy, as well as conventional guidance. The length of prehabilitation was determined by the waiting time till surgery alone. The control group will receive the conventional guidance, including drug treatment recommendations for chronic disease, quit smoking and abstinence. Both of the groups are also provided some useful information about surgery process. The functional capability will be examined for both groups at several time points (baseline, the day before surgery,4 weeks postoperatively) The primary end point is functional walking capacity as measured by the 6 minutes walking distance (6MWD) 4 weeks postoperatively, health-related quality of life scales and cancer-related fatigue. The secondary end points include self-reported physical activity, and prognosis information (postoperative complications, length of hospital stay, ICU stay time, hospitalization expenses, etc.).
- Conditions
- Colorectal Cancer
- Being tested
- Multimodal prehabilitation management Multimodal prehabilitation management
- Keywords
- Prehabilitation, Quality of life, Cancer-related fatigue, Colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal prehabilitation management Multimodal prehabilitation managementBehavioural
Multimodal prehabilitation strategy includes physical exercise (moderate aerobic exercise combined with resistance exercise ), nutritional suggestion and optimization（whey protein supplement）, and psychological therapy, as well as conventional guidance (including drug treatment recommendations for chronic disease, quit smoking and abstinence).
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation group | Experimental | Multimodal prehabilitation strategy includes physical exercise (moderate aerobic exercise combined with resistance exercise and respiratory training ), nutritional suggestion and optimization#whey protein supplement#, and psychological therapy, as well as conventional guidance (including drug treatment recommendations for chronic disease, quit smoking and abstinence). Receives: Behavioral: Multimodal prehabilitation management Multimodal prehabilitation management |
| Control group | No intervention | The patients will receive the conventional clinical guidance according to The First Affiliated Hospital of Xiamen University, including drug treatment recommendations for chronic disease, quit smoking and abstinence. |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute-walking-distance (6MWD)
Use 6-minute-walking-distance (6MWD) to evaluate the physical functional capability objectively.
Measured: [Time Frame: 4 weeks postoperatively]
Secondary outcomes (2)
Cancer-related fatigue
Use the Cancer Fatigue Scale to measure the fatigue of cancer patients in the last few weeks,The scale has 3 dimensions, include somatic fatigue, emotional fatigue and cognitive fatigue, with 15 entries. The scale is scored on a 5-point scale. Entries 1, 2, 3, 6, 9, 12, and 15 are used to assess somatic fatigue, 5, 8, 11, and 14 are used to assess emotional fatigue, and 4, 7, 10, and 13 are used to assess cognitive fatigue. The scale has a total score of 0-60, with somatic fatigue scoring in the range of 0-28, emotional fatigue and cognitive fatigue both scoring in the range of 0-16, and the higher the score, the more severe the fatigue.
Measured: [Time Frame: 4 weeks postoperatively]
Quality of Life Scale
Use the SF-36 to evaluate the intermediate phase of recovery.The full scale consists of 25 items, including four dimensions and eight individual items, which are disease information (4 items), medical examination information (3 items), treatment information (6 items), and other service information (6 items). The scale was based on the Likert 4 scale, with answers of "not at all", "somewhat", "quite", and "very "The scores of each dimension/item were linearly converted to a scale of 0-100 according to the EORTC manual, and then the mean value was taken to obtain the total scale score.
Measured: [Time Frame: 4 weeks postoperatively]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start1 Apr 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- patients were randomly assigned to the prehabilitation group and control group by online randomization software
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiamen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JiaJun Zhang, Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854394
- Sponsor's protocol ID
- NCT20211154469
- Status last verified
- May 2023
- First submitted
- 25 Apr 2023
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Multimodal Prehabilitation on Functional Recovery and Quality of Life After Colorectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT05854394
- Acronym / sponsor ID
- NCT20211154469
- Conditions
- Colorectal Cancer
- Keywords
- Prehabilitation, Quality of life, Cancer-related fatigue, Colorectal cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xiamen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 May 2023 (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 process of enhancing an individual's functional capacity to optimize physiologic reserves before an operation to withstand the stress of surgery has been coined prehabilitation. This is a prospective randomized controlled trail, designed to explore if the patients who take Colorectal Cancer Surgery will benefit from short-term multimodal prehabilitation strategy. multimodal prehabilitation includes exercise, nutrition supplement and physiology management preoperatively. It starts from the day that patients decide to take the surgery until the day before surgery, lasting 1~2 week in The First Affiliated Hospital of Xiamen University. And investigators follow-up patients until 4 weeks after surgery to investigate if multimodal prehabilitation strategy can improve the postoperative functional recovery and improve the quality of life #reduce complications and improve prognosis.
Detailed description
The process of enhancing an individual's functional capacity to optimize physiologic reserves before an operation to withstand the stress of surgery has been coined prehabilitation. It has been confirm that trimodal prehabilitation strategy including exercise, diet and psychology guidance could improve postoperative functional recovery after surgery for patients undergoing colorectal resection. Although many clinical studies have confirmed that preoperative exercise for patients undergoing colorectal cancer surgery is safe and useful, but the prehabilitation strategy in previous studies usually takes 4~8 weeks. However, patient suspected of malignant tumor often wouldn't wait for such a long period. Investigators therefore designed this study to investigate if a 1~2 week multimodal prehabilitation strategy benefits the patients undergoing laparoscopic colorectal cancer resection. There will be 100 patients awaiting operation for primary colorectal cancer recruited in this research at The First Affiliated Hospital of Xiamen University.
After informed consent was obtained, the patients will be divided into two groups randomly, the prehibilitation group and control group.
The prehabilitation group will receive an individual trimodal prehabilitation strategy after a complete assessment, including physical exercise, nutritional optimization, and psychological therapy, as well as conventional guidance. The length of prehabilitation was determined by the waiting time till surgery alone. The control group will receive the conventional guidance, including drug treatment recommendations for chronic disease, quit smoking and abstinence. Both of the groups are also provided some useful information about surgery process. The functional capability will be examined for both groups at several time points (baseline, the day before surgery,4 weeks postoperatively) The primary end point is functional walking capacity as measured by the 6 minutes walking distance (6MWD) 4 weeks postoperatively, health-related quality of life scales and cancer-related fatigue. The secondary end points include self-reported physical activity, and prognosis information (postoperative complications, length of hospital stay, ICU stay time, hospitalization expenses, etc.).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- patients were randomly assigned to the prehabilitation group and control group by online randomization software
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation group | Experimental | Behavioral: Multimodal prehabilitation management Multimodal prehabilitation managementMultimodal prehabilitation strategy includes physical exercise (moderate aerobic exercise combined with resistance exercise and respiratory training ), nutritional suggestion and optimization#whey protein supplement#, and psychological therapy, as well as conventional guidance (including drug treatment recommendations for chronic disease, quit smoking and abstinence). |
| Control group | No intervention | –The patients will receive the conventional clinical guidance according to The First Affiliated Hospital of Xiamen University, including drug treatment recommendations for chronic disease, quit smoking and abstinence. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- From 18 y/o to 75 y/o
- Suspected of colorectal cancer
- Decide to take the colorectal cancer radical surgery in The First Hospital Affiliated to Xiamen University
- Patients with post-operative pathological diagnosis of colorectal cancer
Key exclusion criteria (3 listed)
- Refuse or fail to cooperate the study (due to any reason)
- Unable to tolerate prehabilitaion strategy (including exercise guide, whey protein and psycho-relaxation exercise)
- Other severe cardio-pulmonary diseases that would affect the 6MWD
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 |
|---|---|---|
| Multimodal prehabilitation management Multimodal prehabilitation managementMultimodal prehabilitation strategy includes physical exercise (moderate aerobic exercise combined with resistance exercise ), nutritional suggestion and optimization（whey protein supplement）, and psychological therapy, as well as conventional guidance (including drug treatment recommendations for chronic disease, quit smoking and abstinence). | Behavioural | Prehabilitation group |
Primary outcome
6-minute-walking-distance (6MWD)
Time frame: [Time Frame: 4 weeks postoperatively]
Use 6-minute-walking-distance (6MWD) to evaluate the physical functional capability objectively.
2 secondary outcomes
Cancer-related fatigue
Time frame: [Time Frame: 4 weeks postoperatively]
Quality of Life Scale
Time frame: [Time Frame: 4 weeks postoperatively]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: Yes
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal prehabilitation management Multimodal prehabilitation management in people with Colorectal Cancer, run by Xiamen University at 1 site in China.
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 11 May 2023. 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 China. 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 JiaJun Zhang, Master of Medicine (+8618298370130, zjiajunmail@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute-walking-distance (6MWD) (time frame: [Time Frame: 4 weeks postoperatively]). 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 11 May 2023.