NCT05594069

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 26, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

November 24, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

8 months

First QC Date

October 14, 2022

Last Update Submit

November 14, 2023

Conditions

Triple Pre-rehabilitationRadiotherapyHead and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • Critical weight loss

    Weight loss over 5% during radiotherapy

    About 6 weeks

Secondary Outcomes (11)

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

    About 6 weeks

  • Physical performance

    About 6 weeks

  • Physical performance

    About 6 weeks

  • Physical performance

    About 6 weeks

  • Body composition measured by Bioelectrical Impedance Analysis (BIA)

    About 6 weeks

  • +6 more secondary outcomes

Study Arms (2)

Pre Group

EXPERIMENTAL

intervention before and during radiotherapy

Other: triple pre-rehabilitationOther: triple rehabilitation

Re Group

OTHER

intervention during radiotherapy only

Other: triple rehabilitation

Interventions

triple pre-rehabilitationOTHER

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.

Pre Group
triple rehabilitationOTHER

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.

Pre GroupRe Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≤ 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin medical university cancer institute and hospital

Tianjin, China

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Qian Lu, Professor

    School of Nursing Peking University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

October 14, 2022

First Posted

October 26, 2022

Study Start

November 24, 2022

Primary Completion

July 13, 2023

Study Completion

October 30, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)