Multi-mode Rehabilitation of Abdominal Tumor Patients Undergoing Concurrent Chemoradiotherapy

NCT ID: NCT05325554

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-07
• Study Completion Date: 2024-01-31

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.

Conditions

Concurrent Chemoradiotherapy;Nutrition；Multimodal Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Research Group

multi-mode rehabilitation

Group Type: EXPERIMENTAL

Multimodal rehabilitation

Intervention Type: BEHAVIORAL

Multimodal rehabilitation

control group

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Multimodal rehabilitation

Multimodal rehabilitation

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongnan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhou Fuxiang

Clinical Professor of Zhongnan Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhongnan Hopital of Wuhan University

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fuxiang Zhou, MD,PhD

Role: CONTACT

fuxiang.zhou@whu.edu.cn

+86-027-67813155

Facility Contacts

Fuxiang Zhou, MD

Role: primary

fuxiang.zhou@whu.edu.cn

+86-027-67813155

Other Identifiers

HCCSC AB05

Identifier Type: -

Identifier Source: org_study_id