Gastric CancerNCT05445401
Pre-rehabilitation in Neoadjuvant Patients With Gastric Cancer
A study testing Pre-rehabilitation and Standard medical care in people with Gastric Cancer, run by The First Hospital of Jilin University.
Trial summary
In this study, patients with traditional neoadjuvant gastric cancer were used as controls to explore whether the triple pre-rehabilitation interventions of exercise, nutrition and psychology during the neoadjuvant period before surgery could improve the functional reserve of neoadjuvant gastric cancer patients and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Pre-rehabilitation and Standard medical care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 30 Jun 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in clinical research, fully understand and inform this research and sign the Informed Consent Form (ICF), and are willing to follow and have the ability to complete all experimental procedures;
- The age when signing the informed consent form is 18 to 65 years old, male or female;
- Advanced gastric adenocarcinoma patients diagnosed with clinical stage II-III by CT, MRI, gastroscope and pathology (based on the 8th edition UICC/AJCC staging);
- The function of major organs is normal;
- No history of gastric cancer surgery, chemotherapy or immunotherapy;
- Not accompanied by systemic infection requiring antibiotic treatment;
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- After general examination, it is planned to undergo neoadjuvant immunotherapy and neoadjuvant chemotherapy followed by surgery;
- No contraindications related to CT and MRI examinations;
- ECOG score of 0-2 points;
Who cannot join
- The patient has a history of chemotherapy and immunotherapy in the past;
- The patient cannot undergo CT or MRI scan, or has artifacts that cannot be assessed;
- The patient refuses to participate in the study;
- Patients who are going to undergo or have previously received organ or bone marrow transplantation;
- The patient is pregnant, breastfeeding or unable to take appropriate contraceptive measures;
- Patients with mental illness or related medical history, such as: the patient cannot understand the relevant requirements of this study;
- Patients with human immunodeficiency virus (HIV) infection, active pulmonary tuberculosis or other severe, acute and chronic diseases that may increase the risk of participating in research and research drugs, and who are judged by the investigator to be unsuitable for participating in clinical research;
- Other relevant factors are considered unsuitable for participating in the research by the researcher.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Pilot Study of Pre-rehabilitation in Neoadjuvant Patients With Gastric Cancer
In this study, patients with traditional neoadjuvant gastric cancer were used as controls to explore whether the triple pre-rehabilitation interventions of exercise, nutrition and psychology during the neoadjuvant period before surgery could improve the functional reserve of neoadjuvant gastric cancer patients and accelerate postoperative recovery.
Read the detailed description
Internationally, pre-rehabilitation strategies have been widely used in surgery. Due to the late start of the concept of enhanced rehabilitation in my country, the research on pre-rehabilitation in my country is still in its infancy, and the research on pre-rehabilitation in gastric cancer is basically in a blank state. Domestic scholars have compared the rehabilitation of gastric cancer patients in the exercise-based pre-rehabilitation group and the postoperative rapid rehabilitation group, and found that the postoperative stress response, insulin resistance, and inflammatory response in the pre-rehabilitation group were lower than those in the conventional treatment group, and their nutritional status was improved. faster. The pre-rehabilitation model of comprehensive exercise, nutritional support and psychological intervention is rarely used in gastric cancer patients, and there is a lack of high-quality clinical data and related research.
Neoadjuvant chemotherapy and neoadjuvant chemotherapy combined with immunotherapy are the current research hotspots in locally advanced gastric cancer. The current research studies focus on tumor regression and prognosis and survival. However, the preoperative treatment cycle of neoadjuvant gastric cancer patients is long. If there is a lack of long-term and continuous effective management and guidance during the neoadjuvant therapy, it is very easy to lead to nutritional and nutritional deficiencies after neoadjuvant therapy. The poor physical condition makes the patient suffer from physical and psychological pain.
Therefore, we considered whether it is possible to carry out effective, convenient and economical rehabilitation training treatment for neoadjuvant gastric cancer patients before surgery, so as to prevent the occurrence of surgical risks and other complications in the preoperative stage, improve the functional reserve of neoadjuvant gastric cancer patients and respond to surgery. stimulated and accelerated postoperative recovery.
- Conditions
- Gastric Cancer
- Being tested
- Pre-rehabilitation, Standard medical care
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-rehabilitationBehavioural
Triple pre-rehabilitation interventions of exercise, nutrition and psychology
Standard medical careBehavioural
Traditional care
| Study group | Role | What they receive |
|---|---|---|
| Pre-rehabilitation group | Experimental | Triple pre-rehabilitation interventions of exercise, nutrition and psychology during the neoadjuvant period Receives: Behavioral: Pre-rehabilitation |
| Conventional group | Placebo comparator | Conventional group Receives: Behavioral: Standard medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minutes walking test
The maximum distance the patient can walk on an unimpeded hard surface in six minutes.
Measured: 1 month after surgery
Scored Patient-Generated Subjective Global Assessment score
Scored Patient-Generated Subjective Global Assessment(PG-SGA), PG-SGA consists of two parts: patient self-assessment and medical staff assessment. The specific contents include body weight, food intake, symptoms, activity and physical function, the relationship between disease and nutritional needs, metabolic needs, Physical examination and other 7 aspects, the first 4 aspects are evaluated by the patients themselves, and the last 3 aspects are evaluated by the medical staff. The overall evaluation includes qualitative evaluation and quantitative evaluation. Higher scores mean a worse outcome.
Measured: 1 month after surgery
DMSM score
Distress Management Screening Measure(DMSM）, is an assessment tool recommended by the US National Comprehensive Cancer Network for screening the level and possible causes of psychological pain. The DMSM questionnaire consists of two parts: the first part is the Psychological Distress Thermometer (DT). The second part is the problem list (PL), which contains 36 factors.Higher scores mean a worse outcome.
Measured: 1 month after surgery
Secondary outcomes (15)
Quality of life score QLQ-C30
Assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ-C30 ).
Measured: 3 month after surgery
Quality of life score QLQ-STO22
Assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires ( QLQ-STO22).
Measured: 3 month after surgery
Postoperative skeletal muscle index of the third lumbar spine plane.
Grip strength (Kg).
Measured: 3 month after surgery
The rate of weight loss (≥10%) .
The rate of weight loss (≥10%) .
Measured: 3 month after surgery
The incidence of sarcopenia.
The incidence of sarcopenia.
Measured: 3 month after surgery
The ratio of actual ONS to recommended ONS.
The ratio of actual ONS to recommended ONS.
Measured: 3 month after surgery
Albumin
Laboratory test: albumin （g/L）
Measured: 3 month after surgery
Hemoglobin
Laboratory test: hemoglobin (g/L)
Measured: 3 month after surgery
Prealbumin.
Laboratory test: prealbumin (g/L)
Measured: 3 month after surgery
Incidence of adverse reactions during neoadjuvant therapy.
Incidence of adverse reactions during neoadjuvant therapy.
Measured: 1 month after surgery
Completion rate of neoadjuvant therapy for gastric cancer
Number of completed courses/number of regimen courses
Measured: 1 month after surgery
Surgery rate after neoadjuvant therapy for gastric cancer.
Surgery rate after neoadjuvant therapy for gastric cancer.
Measured: 1 month after surgery
TRG grading after neoadjuvant therapy for gastric cancer.
TRG grading after neoadjuvant therapy for gastric cancer.
Measured: 1 month after surgery
R0 resection rate
R0 resection rate
Measured: 1 month after surgery
Postoperative complication rate of grade IIIa or above.
Postoperative complication rate of grade IIIa or above.
Measured: 3 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quan Wang, The First Hospital of Jilin University
- Investigators
- Quan Wang, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445401
- Sponsor's protocol ID
- STARS-GC06
- Status last verified
- Jul 2022
- First submitted
- 23 Jun 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- 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 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Pre-rehabilitation in Neoadjuvant Patients With Gastric Cancer
- ClinicalTrials.gov ID
- NCT05445401
- Acronym / sponsor ID
- STARS-GC06
- Conditions
- Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 6 Jul 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.
In this study, patients with traditional neoadjuvant gastric cancer were used as controls to explore whether the triple pre-rehabilitation interventions of exercise, nutrition and psychology during the neoadjuvant period before surgery could improve the functional reserve of neoadjuvant gastric cancer patients and accelerate postoperative recovery.
Detailed description
Internationally, pre-rehabilitation strategies have been widely used in surgery. Due to the late start of the concept of enhanced rehabilitation in my country, the research on pre-rehabilitation in my country is still in its infancy, and the research on pre-rehabilitation in gastric cancer is basically in a blank state. Domestic scholars have compared the rehabilitation of gastric cancer patients in the exercise-based pre-rehabilitation group and the postoperative rapid rehabilitation group, and found that the postoperative stress response, insulin resistance, and inflammatory response in the pre-rehabilitation group were lower than those in the conventional treatment group, and their nutritional status was improved. faster. The pre-rehabilitation model of comprehensive exercise, nutritional support and psychological intervention is rarely used in gastric cancer patients, and there is a lack of high-quality clinical data and related research.
Neoadjuvant chemotherapy and neoadjuvant chemotherapy combined with immunotherapy are the current research hotspots in locally advanced gastric cancer. The current research studies focus on tumor regression and prognosis and survival. However, the preoperative treatment cycle of neoadjuvant gastric cancer patients is long. If there is a lack of long-term and continuous effective management and guidance during the neoadjuvant therapy, it is very easy to lead to nutritional and nutritional deficiencies after neoadjuvant therapy. The poor physical condition makes the patient suffer from physical and psychological pain.
Therefore, we considered whether it is possible to carry out effective, convenient and economical rehabilitation training treatment for neoadjuvant gastric cancer patients before surgery, so as to prevent the occurrence of surgical risks and other complications in the preoperative stage, improve the functional reserve of neoadjuvant gastric cancer patients and respond to surgery. stimulated and accelerated postoperative recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-rehabilitation group | Experimental | Behavioral: Pre-rehabilitationTriple pre-rehabilitation interventions of exercise, nutrition and psychology during the neoadjuvant period |
| Conventional group | Placebo comparator | Behavioral: Standard medical careConventional group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntarily participate in clinical research, fully understand and inform this research and sign the Informed Consent Form (ICF), and are willing to follow and have the ability to complete all experimental procedures;
- The age when signing the informed consent form is 18 to 65 years old, male or female;
- Advanced gastric adenocarcinoma patients diagnosed with clinical stage II-III by CT, MRI, gastroscope and pathology (based on the 8th edition UICC/AJCC staging);
- The function of major organs is normal;
- No history of gastric cancer surgery, chemotherapy or immunotherapy;
Key exclusion criteria (8 listed)
- The patient has a history of chemotherapy and immunotherapy in the past;
- The patient cannot undergo CT or MRI scan, or has artifacts that cannot be assessed;
- The patient refuses to participate in the study;
- Patients who are going to undergo or have previously received organ or bone marrow transplantation;
- The patient is pregnant, breastfeeding or unable to take appropriate contraceptive measures;
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 |
|---|---|---|
| Pre-rehabilitationTriple pre-rehabilitation interventions of exercise, nutrition and psychology | Behavioural | Pre-rehabilitation group |
| Standard medical careTraditional care | Behavioural | Conventional group |
Primary outcome
6 minutes walking test
Time frame: 1 month after surgery
The maximum distance the patient can walk on an unimpeded hard surface in six minutes.
Scored Patient-Generated Subjective Global Assessment score
Time frame: 1 month after surgery
Scored Patient-Generated Subjective Global Assessment(PG-SGA), PG-SGA consists of two parts: patient self-assessment and medical staff assessment. The specific contents include body weight, food intake, symptoms, activity and physical function, the relationship between disease and nutritional needs, metabolic needs, Physical examination and other 7 aspects, the first 4 aspects are evaluated by the patients themselves, and the last 3 aspects are evaluated by the medical staff. The overall evaluation includes qualitative evaluation and quantitative evaluation. Higher scores mean a worse outcome.
DMSM score
Time frame: 1 month after surgery
Distress Management Screening Measure(DMSM）, is an assessment tool recommended by the US National Comprehensive Cancer Network for screening the level and possible causes of psychological pain. The DMSM questionnaire consists of two parts: the first part is the Psychological Distress Thermometer (DT). The second part is the problem list (PL), which contains 36 factors.Higher scores mean a worse outcome.
15 secondary outcomes
Quality of life score QLQ-C30
Time frame: 3 month after surgery
Quality of life score QLQ-STO22
Time frame: 3 month after surgery
Postoperative skeletal muscle index of the third lumbar spine plane.
Time frame: 3 month after surgery
The rate of weight loss (≥10%) .
Time frame: 3 month after surgery
The incidence of sarcopenia.
Time frame: 3 month after surgery
The ratio of actual ONS to recommended ONS.
Time frame: 3 month after surgery
Albumin
Time frame: 3 month after surgery
Hemoglobin
Time frame: 3 month after surgery
Prealbumin.
Time frame: 3 month after surgery
Incidence of adverse reactions during neoadjuvant therapy.
Time frame: 1 month after surgery
Completion rate of neoadjuvant therapy for gastric cancer
Time frame: 1 month after surgery
Surgery rate after neoadjuvant therapy for gastric cancer.
Time frame: 1 month after surgery
TRG grading after neoadjuvant therapy for gastric cancer.
Time frame: 1 month after surgery
R0 resection rate
Time frame: 1 month after surgery
Postoperative complication rate of grade IIIa or above.
Time frame: 3 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- 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.
Quan Wang principal investigator
The First Hospital of Jilin University
Questions about this trial
What is this clinical trial studying?
A study testing Pre-rehabilitation and Standard medical care in people with Gastric Cancer, run by The First Hospital of Jilin University.
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 9 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: status not confirmed, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Meng Li (18569951013, lm17@mails.jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minutes walking test (time frame: 1 month after surgery). The study lists 3 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 27 Jul 2022.