Feasibility Study on the Implementation of a Supervised, Home-based Adapted Physical Activity Program for Patients With Head and Neck Cancer (PREPACHIR ORL)

Feasibility Study on the Implementation of a Supervised, Home-based Adapted Physical Activity Program During the Preoperative Phase for Patients With Head and Neck Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Head & Neck Cancer
• Intervention / Treatment: Other: physical activity program

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Doriane Richard, PhD; Phone Number: +33232082985; Email: doriane.richard@chb.unicancer.fr
• Study Contact Backup: Name: Elise Carpentier; Phone Number: +33232082985; Email: elise.carpentier@chb.unicancer.fr

Study Locations

• France
  • Rouen, France
    • Centre Henri Becquerel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supervised physical activity program; Realisation of a supervised home-based physical activity program	Other: physical activity program; Supervised physical activity exercices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the impact of the physical activity program on self-efficacy	Assessment by General Self Efficacy scale	21 days

Collaborators and Investigators

• Sponsor: Centre Henri Becquerel
• Investigators: Principal Investigator: Elise Carpentier, Centre Henri Becquerel

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: home-based; Physical activity program
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: CHB25.07; 2025-A01638-41 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No