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NCT Number: NCT05594069

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

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.

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Key information

Conditions

Triple Pre-rehabilitation Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site Radiotherapy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin medical university cancer institute and hospital

Tianjin, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

triple pre-rehabilitation

Other

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

Other

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 outcomes

  1. Critical weight loss

    Time frame: About 6 weeks

    Weight loss over 5% during radiotherapy

Secondary outcomes

  1. Rate of adverse reactions of radiotherapy assessed by CTCAE v5.0

    Time frame: About 6 weeks

    Adverse reactions of radiotherapy

  2. Physical performance

    Time frame: About 6 weeks

    Physical performance measured by the 4-Meter Walk Test

  3. Physical performance

    Time frame: About 6 weeks

    Physical performance measured by 30-Second Chair Stand Test (30-SCST)

  4. Physical performance

    Time frame: About 6 weeks

    Physical performance measured by hand grip strength

  5. Body composition measured by Bioelectrical Impedance Analysis (BIA)

    Time frame: About 6 weeks

    Body composition measured by Bioelectrical Impedance Analysis (BIA)

  6. Quality of life of patients assessed by QLQ-C30

    Time frame: About 6 weeks

    Quality of life of patients assessed by QLQ-C30

  7. Intake assessed by a simple diet self-assessment tool (SDSAT)

    Time frame: About 6 weeks

    Intake assessed by a simple diet self-assessment tool (SDSAT)

  8. Psychological status assessed by hospital anxiety and depression scale (HADS)

    Time frame: About 6 weeks

    Psychological status assessed by hospital anxiety and depression scale (HADS)

  9. Number of participants with intervention-related adverse events

    Time frame: About 6 weeks

    Number of participants with intervention-related adverse events

  10. Patients in the intervention group were interviewed about the compliance of the study

    Time frame: About 6 weeks

    Patients in the intervention group were interviewed about the compliance of the study

  11. Patients in the intervention group were interviewed about the experience of the study

    Time frame: About 6 weeks

    Patients in the intervention group were interviewed about the experience of the study

Sponsors and collaborators

Lead sponsor

Peking University

Other

Collaborators

  • China International Medical Foundation

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 26, 2022
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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