Multi-mode Rehabilitation of Abdominal Tumor Patients Undergoing Concurrent Chemoradiotherapy
Primary Purpose
Concurrent Chemoradiotherapy;Nutrition;Multimodal Rehabilitation
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Multimodal rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Concurrent Chemoradiotherapy;Nutrition;Multimodal Rehabilitation
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Zhongnan Hopital of Wuhan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Research Group
control group
Arm Description
multi-mode rehabilitation
control group
Outcomes
Primary Outcome Measures
Completion rate of concurrent chemoradiotherapy
Completion rate of concurrent chemoradiotherapy
Changes in grip strength
Changes in grip strength
Improvement of nutritional status
PG-SGA score
Secondary Outcome Measures
Side effects of concurrent radiotherapy and chemotherapy
Side effects of concurrent radiotherapy and chemotherapy
disease free survival
disease free survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05325554
Brief Title
Multi-mode Rehabilitation of Abdominal Tumor Patients Undergoing Concurrent Chemoradiotherapy
Official Title
Research on Multi-mode Rehabilitation of Abdominal Tumor Patients With Simultaneous Radiotherapy and Chemotherapy Based on Mobile Medicine.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongnan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concurrent Chemoradiotherapy;Nutrition;Multimodal Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Research Group
Arm Type
Experimental
Arm Description
multi-mode rehabilitation
Arm Title
control group
Arm Type
No Intervention
Arm Description
control group
Intervention Type
Behavioral
Intervention Name(s)
Multimodal rehabilitation
Intervention Description
Multimodal rehabilitation
Primary Outcome Measure Information:
Title
Completion rate of concurrent chemoradiotherapy
Description
Completion rate of concurrent chemoradiotherapy
Time Frame
up to 12 weeks
Title
Changes in grip strength
Description
Changes in grip strength
Time Frame
up to 12 weeks
Title
Improvement of nutritional status
Description
PG-SGA score
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Side effects of concurrent radiotherapy and chemotherapy
Description
Side effects of concurrent radiotherapy and chemotherapy
Time Frame
up to 12 weeks
Title
disease free survival
Description
disease free survival
Time Frame
up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fuxiang Zhou, MD,PhD
Phone
+86-027-67813155
Email
fuxiang.zhou@whu.edu.cn
Facility Information:
Facility Name
Zhongnan Hopital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430070
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fuxiang Zhou, MD
Phone
+86-027-67813155
Email
fuxiang.zhou@whu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Multi-mode Rehabilitation of Abdominal Tumor Patients Undergoing Concurrent Chemoradiotherapy
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