Clinical trial · Interventional
Prehabilitation and Recovery After Head and Neck Cancer Surgery
Multiphasic Prehabilitation in Patients Undergoing Surgery for Head and Neck Cancer
NCT04598087CI-TRIAL-00056920unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Implementing a multiphasic, multimodal prehabilitation intervention for people undergoing surgery with free flap reconstruction for the treatment of head and neck cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prehabilitation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prehabilitation
- description
- \- Tailored exercise prescription involving aerobic and resistance training, supported by a clinical exercise physiologist.
- interventionNames
- Behavioral: Prehabilitation
Primary outcomes (1)
- measure
- Quality of life: Functional Assessment of Cancer Therapy-Head and Neck Version 4 (FACT-H&N)
- timeFrame
- Baseline, 6 weeks, 6 months and 12 months after surgery (6 months is primary).
- description
- Total score ranges from 0-156. A higher score is a better outcome.
Secondary outcomes (18)
- measure
- Weekly step counts
- timeFrame
- Phase 1 (before surgery)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDWagoner CW, Daun JT, Danyluk J, Twomey R, Murphy L, Peterson M, Gentleman E, Capozzi LC, Francis GJ, Chandarana SP, Hart RD, Matthews TW, McKenzie D, Matthews J, Nakoneshny SC, Schrag C, Sauro KM, Dort JC, Manaloto V, Burnett L, Chisholm A, Lau H, Culos-Reed SN. Multiphasic exercise prehabilitation for patients undergoing surgery for head and neck cancer: a hybrid effectiveness-implementation study protocol. Support Care Cancer. 2023 Nov 28;31(12):726. doi: 10.1007/s00520-023-08164-w. PMID 38012345