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

Head and Neck Cancer Clinical Trial

Official title:

Effect of Triple Pre-rehabilitation on Radiotherapy for Head and Neck Cancer Patients: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05594069
• Other study ID #: Pre-rehabilitation
• Status: Completed
• Phase: N/A
• Start date: November 24, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: November 2023
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: October 30, 2023
• Est. primary completion date: July 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Radiotherapy

Intervention

Other:
• triple pre-rehabilitation
The triple intervention consisted of exercise, nutrition and psychology. Based on the intervention framework, face-to-face intervention adjustment and intensive intervention measures were carried out from the time of enrollment (T0). Combined with weekly telephone follow-up during the intervention, the intervention content formulated face-to-face last time was reviewed, reinforcement behaviors were performed, and questions were answered during the intervention.
• triple rehabilitation
The triple intervention consisted of exercise, nutrition and psychology. Based on the intervention framework, face-to-face intervention adjustment and intensive intervention measures were carried out at the time of the beginning of radiotherapy (T1), and the middle stage of radiotherapy (T2). Combined with weekly telephone follow-up during the intervention, the intervention content formulated face-to-face last time was reviewed, reinforcement behaviors were performed, and questions were answered during the intervention.

Locations

Country	Name	City	State
China	Tianjin medical university cancer institute and hospital	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Peking University	China International Medical Foundation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Critical weight loss	Weight loss over 5% during radiotherapy	About 6 weeks
Secondary	Rate of adverse reactions of radiotherapy assessed by CTCAE v5.0	Adverse reactions of radiotherapy	About 6 weeks
Secondary	Physical performance	Physical performance measured by the 4-Meter Walk Test	About 6 weeks
Secondary	Physical performance	Physical performance measured by 30-Second Chair Stand Test (30-SCST)	About 6 weeks
Secondary	Physical performance	Physical performance measured by hand grip strength	About 6 weeks
Secondary	Body composition measured by Bioelectrical Impedance Analysis (BIA)	Body composition measured by Bioelectrical Impedance Analysis (BIA)	About 6 weeks
Secondary	Quality of life of patients assessed by QLQ-C30	Quality of life of patients assessed by QLQ-C30	About 6 weeks
Secondary	Intake assessed by a simple diet self-assessment tool (SDSAT)	Intake assessed by a simple diet self-assessment tool (SDSAT)	About 6 weeks
Secondary	Psychological status assessed by hospital anxiety and depression scale (HADS)	Psychological status assessed by hospital anxiety and depression scale (HADS)	About 6 weeks
Secondary	Number of participants with intervention-related adverse events	Number of participants with intervention-related adverse events	About 6 weeks
Secondary	Patients in the intervention group were interviewed about the compliance of the study	Patients in the intervention group were interviewed about the compliance of the study	About 6 weeks
Secondary	Patients in the intervention group were interviewed about the experience of the study	Patients in the intervention group were interviewed about the experience of the study	About 6 weeks