Multi-mode Rehabilitation of Abdominal Tumor Patients Undergoing Concurrent Chemoradiotherapy

Phase

Condition

Peritoneal Cancer

Treatment

N/A

Clinical Study ID

NCT05325554

HCCSC AB05

Ages 18-75
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients who are diagnosed as abdominal malignant tumor by pathology and / or cytologyand 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

Exclusion Criteria:

Clinically significant cardiovascular diseases, such as heart failure (NYHA gradeIII-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, includingcentral nervous system metastasis;
uncontrolled systemic diseases, such as poorly controlled diabetes mellitus;
Allergic to milk, whey protein, etc.

Study Design

February 07, 2022

January 31, 2024

Study 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.

Connect with a study center

Zhongnan Hopital of Wuhan University
Wuhan, Hubei 430070
China
Active - Recruiting

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