Effect of Triple Pre-rehabilitation on Radiotherapy for Head and Neck Cancer Patients

Not Applicable

Completed

• Conditions: Triple Pre-rehabilitation; Radiotherapy; Head and Neck Cancer

• Registration Number: NCT05594069
• Lead Sponsor: Peking University

Brief Summary

To evaluate the intervention effect of triple pre-rehabilitation on head and neck cancer patients with radiotherapy, and process evaluation to further optimize the intervention program.

The pre-rehabilitation intervention was develped previously based on the process of evidence-based-nursing, including interventions of nurtrtion, exercise, and psychology.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-14
• Study First Submitted QC: 2022-10-20
• Study First Posted: 2022-10-26
• Study Start: 2022-11-24
• Primary Completion: 2023-07-13
• Study Completion: 2023-10-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

• 18≤ age < 75 years old
• The pathological diagnosis of HNC included nasopharyngeal cancer, oral cancer, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer, salivary gland cancer;
• Plan to receive radiotherapy
• Basic communication skills
• Volunteer to participate in this study.

Exclusion Criteria

• Combined with other malignant tumors
• Distant metastasis
• Inability to measure body composition, such as metal in the body or inability to stand alone
• With contraindications to exercise (such as cardiovascular and cerebrovascular diseases, respiratory diseases, etc)
• Complicated with severe liver and kidney function damage
• Previous diagnosis of other cancers
• pregnant or lactation women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Critical weight loss	About 6 weeks	Weight loss over 5% during radiotherapy

Secondary Outcome Measures

Name	Time	Method
Body composition measured by Bioelectrical Impedance Analysis (BIA)	About 6 weeks	Body composition measured by Bioelectrical Impedance Analysis (BIA)
Rate of adverse reactions of radiotherapy assessed by CTCAE v5.0	About 6 weeks	Adverse reactions of radiotherapy
Patients in the intervention group were interviewed about the compliance of the study	About 6 weeks	Patients in the intervention group were interviewed about the compliance of the study
Intake assessed by a simple diet self-assessment tool (SDSAT)	About 6 weeks	Intake assessed by a simple diet self-assessment tool (SDSAT)
Number of participants with intervention-related adverse events	About 6 weeks	Number of participants with intervention-related adverse events
Physical performance	About 6 weeks	Physical performance measured by hand grip strength
Quality of life of patients assessed by QLQ-C30	About 6 weeks	Quality of life of patients assessed by QLQ-C30
Patients in the intervention group were interviewed about the experience of the study	About 6 weeks	Patients in the intervention group were interviewed about the experience of the study
Psychological status assessed by hospital anxiety and depression scale (HADS)	About 6 weeks	Psychological status assessed by hospital anxiety and depression scale (HADS)

Trial Locations

Locations (1)

Tianjin medical university cancer institute and hospital; 🇨🇳 Tianjin, China