Rectal CancerNCT06542354
Prehabilitation During Neoadjuvant Chemoradiotherapy for Rectal Cancer
A study testing Physical exercise, Nutrition supplement and Mental support in people with Rectal Cancer, run by Fudan University at 1 site in China.
Trial summary
The purpose of this study is determine whether a trimodel prehabilitation program (combined with physical exercise, nutrition supplement and mental support) during neoadjuvant chemoradiotherapy can help patients with rectal cancer to achieve better postoperative outcomes include perioperative complication rate… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Physical exercise, Nutrition supplement and Mental support
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2021to 20 Mar 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with rectal cancer undergoing/scheduled for neoadjuvant chemoradiotherapy
- Fried Frailty score≥2 (intermediately frail or frail)
- Written consent informed
Who cannot join
- Co-morbiditie contraindicating physical exercise or causing disturbances of conciousness (dementia, Parkinson Disease, previous stroke with paresis, taking carbidopa/levodopa, donepezil or antidepressants)
- Emergent surgery
- ASA grade IV-V
- Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
- Known drug abuse/ alcohol abuse
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Effect of Prehabilitation on Rectal Cancer Surgery Following Neoadjuvant Chemoradiotherapy: A Randomized Prospective Cohort Study
The purpose of this study is determine whether a trimodel prehabilitation program (combined with physical exercise, nutrition supplement and mental support) during neoadjuvant chemoradiotherapy can help patients with rectal cancer to achieve better postoperative outcomes include perioperative complication rate, functional outcomes and quality of life.
Read the detailed description
This study is a prospective, single-center, randomized control trial. Including criteria were (1) Age between 18 and 80 years; (2) Histologically confirmed rectal adenocarcinoma；(3) Performance status (ECOG) 0-2; (4) Undergoing/scheduled for neoadjuvant chemoradiotherapy lasting at least 4 weeks. (5) Fried frailty score ≥2. Patients operated as emergency, pregnant or with comodities constraining physical exercise or causing disturbance of consciousness are excluded.
All particapants were recruited and randomly assigned to receive trimodel prehabilitation program or standard care. All patients were treated with an ERAS protocol. The primary end-point is postoperative complications within 30 days. Complications were diagnosed and classified according to the Clavien-Dindo classification and comprehensive complication index was calculated. The secondary end-points were functional walking capacity, hospital length of stay, nutrition status, patient-reported health related quality of life and immune function markers. The study was approved by the Ethics Committee of Zhongshan Hospital, Fudan University, Shanghai, China. Written informed consent was obtained for patients to participate the study. This study followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline.
- Conditions
- Rectal Cancer
- Being tested
- Physical exercise, Nutrition supplement, Mental support
- Keywords
- prehabilitation
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exerciseBehavioural
Physical exercises personally scheduled consisting of daily aerobic exercise(30mins) of fast walking(≥5km) and resisitance training.
Nutrition supplementDietary supplement
Nutritional counselling is given to patients to ensure their daily proteins and energy requirements are met. Oral nutrition supplement (ENSURE) is provided daily seperated in 2 doses
Mental supportBehavioural
Relaxation exercise and psychological counselling delivered by weekly telephone follow-up
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Experimental | 6-week trimodel prehabilitation program consists of physical exercises, nutrition supplement and mental support for patients with rectal cancer during neoadjuvant chemotherapy before surgery. All patients will receive ERAS care pattern after surgery. Receives: Behavioral: Physical exercise; Dietary Supplement: Nutrition supplement; Behavioral: Mental support |
| Standard care | No intervention | Patients receive no specific interventions mentioned above during their neoadjuvant chemoradiotherapy. All patients undergoing primary leision resection will receive postoperative ERAS care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome
Walking capacity measured by 6-minute walking distance (6MWD)
Measured: at baseline, before surgery, 4 weeks and 8 weeks after surgery
Secondary outcomes (4)
perioperative complication
measured by comprehensive complication index (CCI)
Measured: recorded from the day of surgery to 30 days after surgery
Nutrition status
measured by BMI and SMI
Measured: at baseline, before surgery, 4 and 8 weeks after discharge
Patient-reported outcome measures
using SF-36
Measured: at baseline, before surgery and 30days after discharge
immune function markers
specific immnue cells like CD4/CD8, cytokines, peripheral blood test.
Measured: at baseline, before surgery, 4 and 8 weeks after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start20 Dec 2021
- Primary completion30 Dec 2023
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu jianmin, Fudan University
- Investigators
- Xu Jianmin, MD, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542354
- Sponsor's protocol ID
- preHab-rectal
- Status last verified
- Aug 2024
- First submitted
- 17 Jan 2022
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prehabilitation on Rectal Cancer Surgery Following Neoadjuvant Chemoradiotherapy: A Randomized Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06542354
- Acronym / sponsor ID
- preHab-rectal
- Conditions
- Rectal Cancer
- Keywords
- prehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 7 Aug 2024 (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 purpose of this study is determine whether a trimodel prehabilitation program (combined with physical exercise, nutrition supplement and mental support) during neoadjuvant chemoradiotherapy can help patients with rectal cancer to achieve better postoperative outcomes include perioperative complication rate, functional outcomes and quality of life.
Detailed description
This study is a prospective, single-center, randomized control trial. Including criteria were (1) Age between 18 and 80 years; (2) Histologically confirmed rectal adenocarcinoma；(3) Performance status (ECOG) 0-2; (4) Undergoing/scheduled for neoadjuvant chemoradiotherapy lasting at least 4 weeks. (5) Fried frailty score ≥2. Patients operated as emergency, pregnant or with comodities constraining physical exercise or causing disturbance of consciousness are excluded.
All particapants were recruited and randomly assigned to receive trimodel prehabilitation program or standard care. All patients were treated with an ERAS protocol. The primary end-point is postoperative complications within 30 days. Complications were diagnosed and classified according to the Clavien-Dindo classification and comprehensive complication index was calculated. The secondary end-points were functional walking capacity, hospital length of stay, nutrition status, patient-reported health related quality of life and immune function markers. The study was approved by the Ethics Committee of Zhongshan Hospital, Fudan University, Shanghai, China. Written informed consent was obtained for patients to participate the study. This study followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Experimental | Behavioral: Physical exercise, Dietary Supplement: Nutrition supplement, Behavioral: Mental support6-week trimodel prehabilitation program consists of physical exercises, nutrition supplement and mental support for patients with rectal cancer during neoadjuvant chemotherapy before surgery. All patients will receive ERAS care pattern after surgery. |
| Standard care | No intervention | –Patients receive no specific interventions mentioned above during their neoadjuvant chemoradiotherapy. All patients undergoing primary leision resection will receive postoperative ERAS care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with rectal cancer undergoing/scheduled for neoadjuvant chemoradiotherapy
- Fried Frailty score≥2 (intermediately frail or frail)
- Written consent informed
Key exclusion criteria (5 listed)
- Co-morbiditie contraindicating physical exercise or causing disturbances of conciousness (dementia, Parkinson Disease, previous stroke with paresis, taking carbidopa/levodopa, donepezil or antidepressants)
- Emergent surgery
- ASA grade IV-V
- Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
- Known drug abuse/ alcohol abuse
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 |
|---|---|---|
| Physical exercisePhysical exercises personally scheduled consisting of daily aerobic exercise(30mins) of fast walking(≥5km) and resisitance training. | Behavioural | Prehabilitation |
| Nutrition supplementNutritional counselling is given to patients to ensure their daily proteins and energy requirements are met. Oral nutrition supplement (ENSURE) is provided daily seperated in 2 doses | Dietary supplement | Prehabilitation |
| Mental supportRelaxation exercise and psychological counselling delivered by weekly telephone follow-up | Behavioural | Prehabilitation |
Primary outcome
Functional outcome
Time frame: at baseline, before surgery, 4 weeks and 8 weeks after surgery
Walking capacity measured by 6-minute walking distance (6MWD)
4 secondary outcomes
perioperative complication
Time frame: recorded from the day of surgery to 30 days after surgery
Nutrition status
Time frame: at baseline, before surgery, 4 and 8 weeks after discharge
Patient-reported outcome measures
Time frame: at baseline, before surgery and 30days after discharge
immune function markers
Time frame: at baseline, before surgery, 4 and 8 weeks after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Xu Jianmin, MD study director
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise, Nutrition supplement and Mental support in people with Rectal Cancer, run by Fudan 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 3 inclusion and 5 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 7 Aug 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 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?
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?
Functional outcome (time frame: at baseline, before surgery, 4 weeks and 8 weeks after surgery). 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 7 Aug 2024.