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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.

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05325554
Enrollment
100
Registered
2022-04-13
Start date
2022-02-07
Completion date
2024-01-31
Last updated
2022-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Concurrent Chemoradiotherapy;Nutrition;Multimodal Rehabilitation

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.

Interventions

Multimodal rehabilitation

Sponsors

Zhongnan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Completion rate of concurrent chemoradiotherapyup to 12 weeksCompletion rate of concurrent chemoradiotherapy
Changes in grip strengthup to 12 weeksChanges in grip strength
Improvement of nutritional statusup to 12 weeksPG-SGA score

Secondary

MeasureTime frameDescription
Side effects of concurrent radiotherapy and chemotherapyup to 12 weeksSide effects of concurrent radiotherapy and chemotherapy
disease free survivalup to 12 weeksdisease free survival

Countries

China

Contacts

Primary ContactFuxiang Zhou, MD,PhD
fuxiang.zhou@whu.edu.cn+86-027-67813155

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026