Recruiting

Prehabilitation

Sponsor:

University of Calgary

Code:

NCT04598087

Conditions

Head and Neck Cancer

Head and Neck Neoplasms

Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prehabilitation

Study Details

Brief summary:

Implementing a multiphasic, multimodal prehabilitation intervention for people undergoing surgery with free flap reconstruction for the treatment of head and neck cancer.

Conditions

Head and Neck Cancer

Head and Neck Neoplasms

Surgery

Study ID

NCT04598087

Start date

Feb 9, 2022

Status verified date

Feb, 2022

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Aged ≥18 years;
  • Histologically verified primary head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, larynx, or in lymph nodes of the neck from an unknown primary tumour
  • Scheduled to undergo oncologic resection or resection for benign disease with free flap reconstruction
  • Approval received from a clinical exercise physiologist (CSEP-CEP) and/or clinician
  • Ability to provide written informed consent and understand study information in English

Exclusion Criteria:

  • Neurological or musculoskeletal co-morbidity inhibiting exercise
  • Diagnosed psychotic, addictive, or major cognitive disorders
  • Severe coronary artery disease (Canadian Cardiovascular Society class III or greater)
  • Significant congestive heart failure (New York Heart Association class III or greater)

Study Design

Enrollment

96 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Prehabilitation

- Tailored exercise prescription involving aerobic and resistance training, supported by a clinical exercise physiologist.

Interventions

Prehabilitation

The multi-phasic prehabilitation intervention involves three phases: Phase 1: Before surgery (typically \~25 days); Phase 2: The in-hospital phase (typically 10-14 days); Phase 3: Discharge to 6-weeks after surgery.

Primary outcome measure

  • Quality of life: Functional Assessment of Cancer Therapy-Head and Neck Version 4 (FACT-H&N) [ Time Frame: Baseline, 6 weeks, 6 months and 12 months after surgery (6 months is primary). ]

Central Contacts and Locations

Central contacts

Rosemary C Twomey, PhD

+1 403-919-2061rosemary.twomey@ucalgary.ca

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada

Contacts

Rosie Twomey, PhD

4039192061rosemary.twomey@ucalgary.ca

More Information

Sponsor

University of Calgary

Last update posted

Mar 7, 2022

Last verified

Feb, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2022-03-07.