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NCT Number: NCT07318220

Prehabilitation Protocol for Head and Neck Cancer Patients

The purpose of this research is to help researchers understand the barriers, supports, and preferences for prehabilitation. Prehabilitation in this study means head and neck cancer patients will receive nutritional counseling sessions and attend exercise programs before and during radiotherapy/chemoradiotherapy treatment.

Recruiting

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Akina Natori, MD, MSPH

CONTACT

[email protected]

(305) 243-6005

Akina Natori, MD, MSPH

PRINCIPAL_INVESTIGATOR

Erin R Kaye, MD

PRINCIPAL_INVESTIGATOR

Frank Penedo, PhD

PRINCIPAL_INVESTIGATOR

Melissa Pentecost-Lopez, PhD, MS, RDN

PRINCIPAL_INVESTIGATOR

Stuart Samuels, MD, PhD

PRINCIPAL_INVESTIGATOR

Tracy E Crane, PhD, RDN

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Aim 2 Inclusion Criteria: Implement prehabilitation prescription protocol and evaluate the feasibility and acceptability of the prehabilitation prescription protocol in a sample of HNC patients.

  • Age 18 to 80 years old
  • Patients with a diagnosis of non-metastatic squamous cell carcinoma originating in the head and neck (oral cavity, oropharynx, hypopharynx, larynx, and nasopharynx).
  • Patients with a plan for curative radiation therapy (RT) / chemoradiation therapy (CRT) at SCCC* - *Patients who underwent surgery for the HNC are still eligible.
  • Clearance for exercise by the medical team.
  • Patients who do not have their first treatment scheduled within 3 weeks at the time of recruitment.
  • An English or Spanish speaker.

Aim 2 Exclusion Criteria:

  • A patient with a metastatic cancer.
  • A patient who cannot complete the baseline assessment and/or start prehabilitation by the initiation of RT/CRT.
  • Any contraindication for diet change or exercising as determined by a physician.

week for the prior month.

  • A patient who is not an English or Spanish speaker.
  • History of dementia or major psychiatric disease which would interfere with study.
  • History of recent (≤1 yr) stroke, myocardial infarction, or congestive heart failure
  • Eastern Cooperative Oncology Group (ECOG) equal to or higher than 2.

Treatment and study plan

Referral to Oncology Nutritional Counseling and Exercise Program

Behavioral

Participants will be referred by their healthcare provider to an oncology nutritional counseling and exercise program administered standard of care by the Cancer Support Service at the Sylvester Comprehensive Cancer Center. Participants will be scheduled to the predetermined frequency and length of visits with oncology dietitians and exercise physiologists per the prehabilitation prescription protocol developed during the pre-implementation period.

Primary outcomes

  1. Aim 2: Feasibility of Participant Engagement in Prehabilitation Prescription Program

    Time frame: Up to 18 Weeks

    Feasibility will be measured as the percentage of participants that agree to participate in the prehabilitation prescription protocol. Criterion for success: At least (≥) 50% of all eligible participants agree to participate in the prehabilitation prescription protocol.

  2. Aim 2: Feasibility of Participant Attendance to Scheduled Visits of the Prehabilitation Prescription Protocol

    Time frame: Up to 18 Weeks

    Feasibility will be measured as the percentage of participants attending scheduled visits of the prehabilitation prescription protocol. Criterion for success: At least (≥) 70% of participants attend all scheduled visits.

  3. Aim 2: Acceptability of Participants That Feel Satisfied with the Prehabilitation Prescription Protocol

    Time frame: Up to 18 Weeks

    Acceptability will be measured as the percentage of participants that report satisfaction with the prehabilitation prescription protocol. Criterion for success: At least (≥) 80% of participants complete the prehabilitation prescription protocol.

Study contacts

Contact information is provided by the study sponsor or research team.

Akina Natori, MD, MSPH

CONTACT

[email protected]

(305) 243-6005

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Optimizing Cancer Support Services Usage in Patients With Head and Neck Cancer During the Prehabilitation Period

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 5, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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