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

Primary Purpose

Triple Pre-rehabilitation, Radiotherapy, Head and Neck Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
triple pre-rehabilitation
triple rehabilitation
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Triple Pre-rehabilitation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Pre Group

    Re Group

    Arm Description

    intervention before and during radiotherapy

    intervention during radiotherapy only

    Outcomes

    Primary Outcome Measures

    Critical weight loss
    Weight loss over 5% during radiotherapy

    Secondary Outcome Measures

    Rate of adverse reactions of radiotherapy assessed by CTCAE v5.0
    Adverse reactions of radiotherapy
    Physical performance
    Physical performance measured by the 4-Meter Walk Test
    Physical performance
    Physical performance measured by 30-Second Chair Stand Test (30-SCST)
    Physical performance
    Physical performance measured by hand grip strength
    Body composition measured by Bioelectrical Impedance Analysis (BIA)
    Body composition measured by Bioelectrical Impedance Analysis (BIA)
    Quality of life of patients assessed by QLQ-C30
    Quality of life of patients assessed by QLQ-C30
    Intake assessed by a simple diet self-assessment tool (SDSAT)
    Intake assessed by a simple diet self-assessment tool (SDSAT)
    Psychological status assessed by hospital anxiety and depression scale (HADS)
    Psychological status assessed by hospital anxiety and depression scale (HADS)
    Number of participants with intervention-related adverse events
    Number of participants with intervention-related adverse events
    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
    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

    Full Information

    First Posted
    October 14, 2022
    Last Updated
    October 20, 2022
    Sponsor
    Peking University
    Collaborators
    China International Medical Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05594069
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2022 (Anticipated)
    Primary Completion Date
    August 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University
    Collaborators
    China International Medical Foundation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Triple Pre-rehabilitation, Radiotherapy, Head and Neck Cancer

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lichuan Zhang, PhD student
    Phone
    +86-13021240602
    Email
    zhanglichuan@bjmu.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Qian Lu, Professor
    Organizational Affiliation
    School of Nursing Peking University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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