NCT06851988

Brief Summary

Through the implementation of this three-year project, investigators expect to find a safe and effective exercise prescription for patients with oral cancer after surgery. The findings will encourage and promise and add further support to the concept that exercise prescription is worth implementation as part of care for the patients with head and neck cancer.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
May 2023Oct 2027

Study Start

First participant enrolled

May 3, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2024

Completed
1 year until next milestone

First Posted

Study publicly available on registry

February 28, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2027

Expected
Last Updated

February 28, 2025

Status Verified

February 1, 2025

Enrollment Period

2.5 years

First QC Date

February 21, 2024

Last Update Submit

February 24, 2025

Conditions

AgingHigh-intensity Interval TrainingHead and Neck Cancers - Tonsils

Keywords

ExerciseImmunosenescenceRecurrence-free survivalHead and Neck Cancer

Outcome Measures

Primary Outcomes (8)

  • % of participants with phenoage and age

    To evaluate the phenoage acceleration by calculating differencehe of patients with phenoage and age.

    1 month, after CCRT

  • % of participants with phenoage and age

    To evaluate the phenoage acceleration by calculating differencehe of patients with phenoage and age.

    6 month, after CCRT

  • Peak VO2 (ml/min/kg) of participants

    To record the Peak VO2 (ml/min/kg) of participants and to evulate the effectiveness of exercise training

    baseline

  • Peak VO2 (ml/min/kg) of participants

    To record the Peak VO2 (ml/min/kg) of participants and to evulate the effectiveness of exercise training

    1 month, after CCRT

  • Peak VO2 (ml/min/kg) of participants

    To record the Peak VO2 (ml/min/kg) of participants and to evulate the effectiveness of exercise training

    6 month, after CCRT

  • Questionnaire of European Organisation for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN43)

    To assese the quality of life at the Head and Neck participants and evulate the effectiveness of exercise training.The minimum value is 43 and the maximum value is 172

    baseline

  • Questionnaire of European Organisation for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN43)

    To assese the quality of life at the Head and Neck participants and evulate the effectiveness of exercise training.The minimum value is 43 and the maximum value is 172

    1 month, after CCRT

  • Questionnaire of European Organisation for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN43)

    To assese the quality of life at the Head and Neck participants and evulate the effectiveness of exercise training.The minimum value is 43 and the maximum value is 172

    6 month, after CCRT

Study Arms (2)

Head and Neck patient after CCRT treatment with HIIT training

EXPERIMENTAL

After CCRT treatment 4-5 week arrange HIIT training for patient. Two to three times a week ,total 24-36 times. keep follow the PFS and OS

Other: HIIT & Record of physical activities at home.Other: HIIT only

Head and Neck patient after CCRT treatment

NO INTERVENTION

keep follow the PFS and OS

Interventions

HIIT & Record of physical activities at home.OTHER

After CCRT treatment 4-5 week arrange HIIT excise for patient two to three times a week 24-36 times. And record of physical activities at home. According to the record set goal to acheive.

Head and Neck patient after CCRT treatment with HIIT training
HIIT onlyOTHER

After CCRT treatment 4-5 week arrange HIIT excise for patient two to three times a week 24-36 times.

Head and Neck patient after CCRT treatment with HIIT training

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥20
  • Pathology:Squamous cell carcinoma
  • Need CCRT treatment
  • ECOG PS\<2
  • Agree with blood drawing, excise training, questionnaire

You may not qualify if:

  • ECOG PS≥2
  • Unable to tolerate basic exercise, or CCRT treatment
  • Mental illness or any medical illness or concurrent illness that may be aggravated by exercise training or unmanageable
  • Any medical condition that unsuitable for exercise
  • Disagree to trial procedures: exercise, blood draws, questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TuCheng Hospital

New Taipei City, 23652, Taiwan

RECRUITING

MeSH Terms

Conditions

Motor ActivityHead and Neck Neoplasms

Condition Hierarchy (Ancestors)

BehaviorNeoplasms by SiteNeoplasms

Study Officials

  • Chia-Hsun Hsieh

    New Tipei City Tucheng Hospital

    STUDY CHAIR

Central Study Contacts

Wan-Chin Kuo

CONTACT

03-3196200troublefup6@cgmh.org.tw

Kuo

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 21, 2024

First Posted

February 28, 2025

Study Start

May 3, 2023

Primary Completion

October 30, 2025

Study Completion (Estimated)

October 30, 2027

Last Updated

February 28, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)