Clinical trial NCT05594069: Effect of Triple Pre-rehabilitation on Radiotherapy for Head and Neck Cancer Patients
Official title: Effect of Triple Pre-rehabilitation on Radiotherapy for Head and Neck Cancer Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Triple Pre-rehabilitation
Radiotherapy
Head and Neck Cancer
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: China International Medical Foundation
First posted: 2022-10-26
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Critical weight loss
timeFrame: About 6 weeks
Secondary outcomes:
measure: Rate of adverse reactions of radiotherapy assessed by CTCAE v5.0
timeFrame: About 6 weeks
measure: Physical performance
timeFrame: About 6 weeks
measure: Physical performance
timeFrame: About 6 weeks
measure: Physical performance
timeFrame: About 6 weeks
measure: Body composition measured by Bioelectrical Impedance Analysis (BIA)
timeFrame: About 6 weeks
measure: Quality of life of patients assessed by QLQ-C30
timeFrame: About 6 weeks
measure: Intake assessed by a simple diet self-assessment tool (SDSAT)
timeFrame: About 6 weeks
measure: Psychological status assessed by hospital anxiety and depression scale (HADS)
timeFrame: About 6 weeks
measure: Number of participants with intervention-related adverse events
timeFrame: About 6 weeks
measure: Patients in the intervention group were interviewed about the compliance of the study
timeFrame: About 6 weeks
measure: Patients in the intervention group were interviewed about the experience of the study
timeFrame: About 6 weeks
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin medical university cancer institute and hospital
Study officials:
affiliation: School of Nursing Peking University
name: Qian Lu, Professor
role: STUDY_CHAIR
References: