Multi-mode Rehabilitation of Abdominal Tumor Patients Undergoing Concurrent Chemoradiotherapy

NCT05325554 | Unknown Phase 2 DMC

• 1 other identifier: HCCSC AB05
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Concurrent Chemoradiotherapy;Nutrition；Multimodal Rehabilitation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Side effects of concurrent radiotherapy and chemotherapy

  up to 12 weeks

• disease free survival

  up to 12 weeks

Study Arms (2)

Research Group

EXPERIMENTAL

multi-mode rehabilitation

Behavioral: Multimodal rehabilitation

control group

NO INTERVENTION

control group

Interventions

Multimodal rehabilitation BEHAVIORAL

Multimodal rehabilitation

Research Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are diagnosed as abdominal malignant tumor by pathology and / or cytology and 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.

You may not qualify if:

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

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hopital of Wuhan University

Wuhan, Hubei, 430070, China

RECRUITING

Central Study Contacts

Fuxiang Zhou, MD,PhD

CONTACT

+86-027-67813155; fuxiang.zhou@whu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Zhongnan Hospital

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: April 13, 2022
• Study Start: February 7, 2022
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)