Multi-mode Rehabilitation of Abdominal Tumor Patients Undergoing Concurrent Chemoradiotherapy

Phase 2

• Conditions: Concurrent Chemoradiotherapy;Nutrition；Multimodal Rehabilitation
• Interventions: Behavioral: Multimodal rehabilitation

• Registration Number: NCT05325554
• Lead Sponsor: Zhongnan Hospital

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.

Study Timeline

• Study Start: 2022-02-07
• Study First Submitted: 2022-03-08
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-07
• Last Update Submitted: 2022-04-07
• Study First Posted: 2022-04-13
• Last Update Posted: 2022-04-13
• Primary Completion: 2024-01-31
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patients who are diagnosed as abdominal malignant tumor by pathology and / or cytology and intend to receive concurrent radiotherapy and chemotherapy;
2. Estimated survival time ≥ 3 months;
3. ECoG score 0-1;
4. The physical activity is acceptable, and the human body composition analysis and 6-minute walking test can be carried out;
5. Have reading comprehension ability and be able to complete the questionnaire.

Exclusion Criteria

1. 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;
2. Neurological or psychiatric abnormalities affecting cognitive ability, including central nervous system metastasis;
3. uncontrolled systemic diseases, such as poorly controlled diabetes mellitus;
4. Allergic to milk, whey protein, etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Research Group	Multimodal rehabilitation	multi-mode rehabilitation

Primary Outcome Measures

Name	Time	Method
Completion rate of concurrent chemoradiotherapy	up to 12 weeks	Completion rate of concurrent chemoradiotherapy
Improvement of nutritional status	up to 12 weeks	PG-SGA score
Changes in grip strength	up to 12 weeks	Changes in grip strength

Secondary Outcome Measures

Name	Time	Method
disease free survival	up to 12 weeks	disease free survival
Side effects of concurrent radiotherapy and chemotherapy	up to 12 weeks	Side effects of concurrent radiotherapy and chemotherapy

Trial Locations

Locations (1)

Zhongnan Hopital of Wuhan University; 🇨🇳 Wuhan, Hubei, China