NCT07560397

Brief Summary

Head and neck cancers are the seventh most common type of cancer worldwide. The standard of care is surgical removal of the tumor, often accompanied by simultaneous reconstruction of the affected structures. Enhanced post-surgical rehabilitation programs are offered to promote early recovery of functional abilities; they are applicable to all patients and all surgical specialties. Studies have shown a very significant benefit of physical activity prior to surgery in the context of cancers of the digestive or thoracic systems. Multimodal programs that incorporate nutritional and psychosocial factors and include physical exercise have been shown to improve postoperative mobility and physical activity levels in patients with colorectal, gastrointestinal, lung, and prostate cancers. Our hypothesis is based on the premise that implementing an exercise program during the preoperative period could promote a return to optimal functional capacity, reduce the incidence of postoperative pulmonary complications, and lower overall morbidity. Furthermore, we believe that the proposed support would encourage greater patient involvement in their care journey starting in the preoperative period and raise their awareness of the importance of postoperative mobilization. Early patient involvement would thus help develop their sense of self-efficacy and promote behavioral change toward a more active lifestyle suited to their health status. Consequently, maintaining physical activity after surgery and in the post-cancer period-recognized as a factor in secondary and tertiary prevention-would be encouraged.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
28mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

April 24, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

April 24, 2026

Last Update Submit

April 24, 2026

Conditions

Keywords

Physical activity programhome-based

Outcome Measures

Primary Outcomes (1)

  • Assessment of the feasibility of implementing a preoperative adapted physical activity program, supervised via weekly phone calls at home, for patients with head and neck cancer

    Number of patients who completed the adapted physical activity program out of the total number of patients who agreed to participate

    21 days

Secondary Outcomes (1)

  • Assess the impact of the physical activity program on self-efficacy

    21 days

Study Arms (1)

Supervised physical activity program

EXPERIMENTAL

Realisation of a supervised home-based physical activity program

Other: physical activity program

Interventions

Supervised physical activity exercices

Supervised physical activity program

Eligibility Criteria

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

You may qualify if:

  • surgery requiring the placement of a covering flap)
  • Medical prescription of adapted physical activity
  • A period of more than 2 weeks between the announcement of surgery and the surgery itself

You may not qualify if:

  • Absolute contraindications to physical activity
  • Pregnant or breastfeeding women
  • Patients who, for any reason, are unable to understand the study or comply with the trial requirements (language, psychological, or geographical barriers, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Henri Becquerel

Rouen, France

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Elise Carpentier

    Centre Henri Becquerel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2026

First Posted

May 1, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations