Concurrent Chemoradiotherapy;Nutrition；Multimodal RehabilitationPhase 2NCT05325554
Multi-mode Rehabilitation of Abdominal Tumor Patients Undergoing Concurrent Chemoradiotherapy
A Phase 2 study testing Multimodal rehabilitation in people with Concurrent Chemoradiotherapy;Nutrition；Multimodal Rehabilitation, run by Zhongnan Hospital at 1 site in China.
Trial summary
The investigators carry out a multi center, randomized controlled clinical study to analyze the impact of the whole process multi-mode rehabilitation management (nutrition-Sports-Psychology) on the nutritional status, physical status, psychological status, treatment side effects and the completion rate of radiotherapy… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Concurrent Chemoradiotherapy;Nutrition；Multimodal Rehabilitation
- What is being tested?
- Multimodal rehabilitation
- 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
- 7 Feb 2022to 31 Jan 2024
- Phase
- Phase 2
- 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
- Patients who are diagnosed as abdominal malignant tumor by pathology and / or cytology and intend to receive concurrent radiotherapy and chemotherapy;
- Estimated survival time ≥ 3 months;
- ECoG score 0-1;
- The physical activity is acceptable, and the human body composition analysis and 6-minute walking test can be carried out;
- Have reading comprehension ability and be able to complete the questionnaire.
Who cannot join
- Clinically significant cardiovascular diseases, such as heart failure (NYHA grade III-IV), uncontrolled coronary heart disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension or history of myocardial infarction in the past 1 year;
- Neurological or psychiatric abnormalities affecting cognitive ability, including central nervous system metastasis;
- uncontrolled systemic diseases, such as poorly controlled diabetes mellitus;
- Allergic to milk, whey protein, etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hopital of Wuhan University
Wuhan, Hubei, 430070
Fuxiang Zhou, MD, +86-027-67813155, fuxiang.zhou@whu.edu.cn
About this study
Official title: Research on Multi-mode Rehabilitation of Abdominal Tumor Patients With Simultaneous Radiotherapy and Chemotherapy Based on Mobile Medicine.
The investigators carry out a multi center, randomized controlled clinical study to analyze the impact of the whole process multi-mode rehabilitation management (nutrition-Sports-Psychology) on the nutritional status, physical status, psychological status, treatment side effects and the completion rate of radiotherapy and chemotherapy of patients with abdominal tumors; To explore and establish a multi-mode rehabilitation management path for patients with malignant tumors undergoing concurrent radiotherapy and chemotherapy.
Read the detailed description
Research shows that the combination of early nutritional intervention and psychological palliative intervention can improve the quality of life of patients, reduce the probability of depression, improve the prognosis of patients and prolong the overall survival time for up to two months. The research of Peking University Cancer Hospital in China shows that early nutrition and psychological palliative intervention can improve the prognosis of patients with advanced esophageal cancer and prolong the overall survival by nearly three months. The first mock exam (including exercise, nutrition and Psychology) seems to be more effective than a single model of pre rehabilitation. Therefore, the current triple rehabilitation strategy is advocated, namely, high intensity aerobic exercise during the waiting period, nutritional support based on protein supplementation, and psychological support to eliminate anxiety. Tumor multimodal rehabilitation has received more and more attention, but there is no clinical research on the "triple multimodal rehabilitation" of nutrition + Exercise + psychology in patients with abdominal tumor concurrent radiotherapy and chemotherapy. Therefore, the research on the impact of whole process multimodal rehabilitation (nutrition-Exercise-Psychology) on patients with abdominal tumor concurrent radiotherapy and chemotherapy has been carried out, It has important scientific significance and value to promote the rehabilitation and development of tumor patients undergoing concurrent radiotherapy and chemotherapy.
In this study,the investigators carry out a multi center, randomized controlled clinical study to analyze the impact of the whole process multi-mode rehabilitation management (nutrition-Sports- Psychology) on the nutritional status, physical status, psychological status, treatment side effects and the completion rate of radiotherapy and chemotherapy of patients with abdominal tumors; To explore and establish a multi-mode rehabilitation management path for patients with malignant tumors undergoing concurrent radiotherapy and chemotherapy.
- Being tested
- Multimodal rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal rehabilitationBehavioural
Multimodal rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Research Group | Experimental | multi-mode rehabilitation Receives: Behavioral: Multimodal rehabilitation |
| control group | No intervention | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion rate of concurrent chemoradiotherapy
Completion rate of concurrent chemoradiotherapy
Measured: up to 12 weeks
Changes in grip strength
Changes in grip strength
Measured: up to 12 weeks
Improvement of nutritional status
PG-SGA score
Measured: up to 12 weeks
Secondary outcomes (2)
Side effects of concurrent radiotherapy and chemotherapy
Side effects of concurrent radiotherapy and chemotherapy
Measured: up to 12 weeks
disease free survival
disease free survival
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start7 Feb 2022
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concurrent Chemoradiotherapy;Nutrition；Multimodal RehabilitationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Fuxiang, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325554
- Sponsor's protocol ID
- HCCSC AB05
- Status last verified
- Apr 2022
- First submitted
- 8 Mar 2022
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Multi-mode Rehabilitation of Abdominal Tumor Patients With Simultaneous Radiotherapy and Chemotherapy Based on Mobile Medicine.
- ClinicalTrials.gov ID
- NCT05325554
- Acronym / sponsor ID
- HCCSC AB05
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 13 Apr 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.
The investigators carry out a multi center, randomized controlled clinical study to analyze the impact of the whole process multi-mode rehabilitation management (nutrition-Sports-Psychology) on the nutritional status, physical status, psychological status, treatment side effects and the completion rate of radiotherapy and chemotherapy of patients with abdominal tumors; To explore and establish a multi-mode rehabilitation management path for patients with malignant tumors undergoing concurrent radiotherapy and chemotherapy.
Detailed description
Research shows that the combination of early nutritional intervention and psychological palliative intervention can improve the quality of life of patients, reduce the probability of depression, improve the prognosis of patients and prolong the overall survival time for up to two months. The research of Peking University Cancer Hospital in China shows that early nutrition and psychological palliative intervention can improve the prognosis of patients with advanced esophageal cancer and prolong the overall survival by nearly three months. The first mock exam (including exercise, nutrition and Psychology) seems to be more effective than a single model of pre rehabilitation. Therefore, the current triple rehabilitation strategy is advocated, namely, high intensity aerobic exercise during the waiting period, nutritional support based on protein supplementation, and psychological support to eliminate anxiety. Tumor multimodal rehabilitation has received more and more attention, but there is no clinical research on the "triple multimodal rehabilitation" of nutrition + Exercise + psychology in patients with abdominal tumor concurrent radiotherapy and chemotherapy. Therefore, the research on the impact of whole process multimodal rehabilitation (nutrition-Exercise-Psychology) on patients with abdominal tumor concurrent radiotherapy and chemotherapy has been carried out, It has important scientific significance and value to promote the rehabilitation and development of tumor patients undergoing concurrent radiotherapy and chemotherapy.
In this study,the investigators carry out a multi center, randomized controlled clinical study to analyze the impact of the whole process multi-mode rehabilitation management (nutrition-Sports- Psychology) on the nutritional status, physical status, psychological status, treatment side effects and the completion rate of radiotherapy and chemotherapy of patients with abdominal tumors; To explore and establish a multi-mode rehabilitation management path for patients with malignant tumors undergoing concurrent radiotherapy and chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Research Group | Experimental | Behavioral: Multimodal rehabilitationmulti-mode rehabilitation |
| control group | No intervention | –control group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who are diagnosed as abdominal malignant tumor by pathology and / or cytology and intend to receive concurrent radiotherapy and chemotherapy;
- Estimated survival time ≥ 3 months;
- ECoG score 0-1;
- The physical activity is acceptable, and the human body composition analysis and 6-minute walking test can be carried out;
- Have reading comprehension ability and be able to complete the questionnaire.
Key exclusion criteria (4 listed)
- Clinically significant cardiovascular diseases, such as heart failure (NYHA grade III-IV), uncontrolled coronary heart disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension or history of myocardial infarction in the past 1 year;
- Neurological or psychiatric abnormalities affecting cognitive ability, including central nervous system metastasis;
- uncontrolled systemic diseases, such as poorly controlled diabetes mellitus;
- Allergic to milk, whey protein, etc.
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 rehabilitationMultimodal rehabilitation | Behavioural | Research Group |
Primary outcome
Completion rate of concurrent chemoradiotherapy
Time frame: up to 12 weeks
Completion rate of concurrent chemoradiotherapy
Changes in grip strength
Time frame: up to 12 weeks
Changes in grip strength
Improvement of nutritional status
Time frame: up to 12 weeks
PG-SGA score
2 secondary outcomes
Side effects of concurrent radiotherapy and chemotherapy
Time frame: up to 12 weeks
disease free survival
Time frame: up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Individual participant dataSharing planned: No
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 Phase 2 study testing Multimodal rehabilitation in people with Concurrent Chemoradiotherapy;Nutrition；Multimodal Rehabilitation, run by Zhongnan Hospital 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 5 inclusion and 4 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 13 Apr 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Fuxiang Zhou, MD,PhD (+86-027-67813155, fuxiang.zhou@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion rate of concurrent chemoradiotherapy (time frame: up to 12 weeks). 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 13 Apr 2022.