Multi-mode Rehabilitation of Abdominal Tumor Patients Undergoing Concurrent Chemoradiotherapy

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.

Study Overview

• Status: Recruiting
• Conditions: Concurrent Chemoradiotherapy;Nutrition；Multimodal Rehabilitation
• Intervention / Treatment: Behavioral: Multimodal rehabilitation

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Fuxiang Zhou, MD,PhD; Phone Number: +86-027-67813155; Email: fuxiang.zhou@whu.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430070
      • Recruiting
      • Zhongnan Hopital of Wuhan University
      • Contact: Fuxiang Zhou, MD; Phone Number: +86-027-67813155; Email: fuxiang.zhou@whu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group
Experimental: Research Group; multi-mode rehabilitation	Behavioral: Multimodal rehabilitation; Multimodal rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion rate of concurrent chemoradiotherapy	Completion rate of concurrent chemoradiotherapy	up to 12 weeks
Changes in grip strength	Changes in grip strength	up to 12 weeks
Improvement of nutritional status	PG-SGA score	up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects of concurrent radiotherapy and chemotherapy	Side effects of concurrent radiotherapy and chemotherapy	up to 12 weeks
disease free survival	disease free survival	up to 12 weeks

Collaborators and Investigators

• Sponsor: Zhongnan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2022
• Primary Completion (Anticipated): January 31, 2024
• Study Completion (Anticipated): January 31, 2024

Study Registration Dates

• First Submitted: March 8, 2022
• First Submitted That Met QC Criteria: April 7, 2022
• First Posted (Actual): April 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Abdominal Neoplasms
• Other Study ID Numbers: HCCSC AB05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No