Head and Neck CarcinomaNCT06079697
An Exercise Prehabilitation Intervention for Improving Mobility and Recovery Outcomes in Patients Undergoing Head and Neck Cancer Surgery
A study testing Electronic Health Record Review, Exercise Intervention and Medical Device Usage and Evaluation in people with Head and Neck Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
This clinical trial evaluates a prehabilitation exercise intervention for improving mobility and recovery outcomes in patients undergoing surgery for head and neck cancer. Prehabilitation focuses on optimizing health before surgery in order to improve outcomes after surgery. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Head and Neck Carcinoma
- What is being tested?
- Electronic Health Record Review, Exercise Intervention and Medical Device Usage and Evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 years of age and younger than 89 years of age. Both men and women and members of all races and ethnic groups may be included
- Planned to undergo major head and neck cancer surgery with free tissue transfer reconstruction at Oregon Health and Science University (OHSU) with the Department of Otolaryngology-Head and Neck Surgery with an expected length of stay (LOS) of 3 days or more
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Non-English speaking
- Planned postoperative admission to the intensive care unit (ICU)
- Social or psychiatric conditions that may interfere with compliance
- Further exclusion criteria may be applied due to conditions that may impact the ability to safely exercise as well as utilize the Fitbit devices:
- Symptoms of or ongoing work-up for unstable angina, uncontrolled tachyarrhythmias, decompensated heart failure, severe aortic stenosis, hypertrophic obstructive cardiomyopathy, uncontrolled hypertension (HTN), uncontrolled pulmonary HTN or uncontrolled asthma
- History of chest pain, dizziness or syncope with exercise
Show all 11Show fewer
- Bony metastases to the spine or extremities
- Falls in the last year
- Cognitive impairments limiting safety or ability to use technology
- Impaired mobility requiring the use of assistive devices, such as use of a walker or wheelchair at baseline
- Isolation precautions, as they would not be allowed to ambulate on a patient floor post-operatively
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: The Effect of Exercise Prehabilitation on Post-Operative Recovery After Head and Neck Cancer Surgery
This clinical trial evaluates a prehabilitation exercise intervention for improving mobility and recovery outcomes in patients undergoing surgery for head and neck cancer. Prehabilitation focuses on optimizing health before surgery in order to improve outcomes after surgery. Prehabilitation may include aspects of nutrition, exercise, mental health, or a combination of these. Exercise has been proven to improve anxiety, depression, fatigue, health related quality of life, and physical function among patients undergoing cancer treatment, as well as cancer survivors. The prehabilitation exercise intervention being studied includes a daily walking program, sit-to-stand training, and standing therapeutic exercises before patients undergo surgery. Receiving this prehabilitation exercise intervention prior to surgery may improve mobility and recovery outcomes in patients after surgery for head and neck cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the impact of an exercise prehabilitation program on post-operative outcomes after head and neck cancer surgery.
SECONDARY OBJECTIVE:
- To evaluate the impact of an exercise prehabilitation program on post-operative weight loss, depression and discharge disposition after head and neck cancer surgery.
EXPLORATORY OBJECTIVES:
- To evaluate the adherence rate to and satisfaction with a pre-operative exercise prehabilitation program, which will be evaluated at the end of their inpatient stay.
II. To evaluate the impact of lower extremity free tissue transfer on post-operative recovery after undergoing an exercise prehabilitation program, which will be evaluated at the end of their inpatient stay.
III. To evaluate the impact of the duration of prehabilitation on post-operative outcomes after head and neck cancer surgery, which will be evaluated at the end of their inpatient stay.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients wear a Fitbit or personal wearable device beginning on day 1 and receive the prehabilitation exercise intervention consisting of 2000-4000 steps per day, sit-to-stand training 3 days per week, and standing therapeutic exercises 3 days per week beginning on day 2 for up to 2-5 weeks prior to surgery. Patients continue wearing the Fitbit personal wearable device from post-operative day 1 until hospital discharge or until 14 days post-surgery.
ARM II: Patients wear a Fitbit personal wearable device beginning on day 1 up until day of surgery and then from post-operative day 1 until hospital discharge or until 14 days post-surgery.
- Conditions
- Head and Neck Carcinoma
- Being tested
- Electronic Health Record Review, Exercise Intervention, Medical Device Usage and Evaluation, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Health Record ReviewOther
Ancillary studies
Receive prehabilitation exercise intervention
Medical Device Usage and EvaluationOther
Wear Fitbits
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (prehabilitation) | Experimental | Patients wear a Fitbit or a personal wearable device beginning on day 1 and receive the prehabilitation exercise intervention consisting of 2000-4000 steps per day, sit-to-stand training 3 days per week, and standing therapeutic exercises 3 days per week beginning on day 2 for up to 2-5 weeks prior to surgery. Patients continue wearing the Fitbit or personal wearable device from post-operative day 1 until hospital discharge or until 14 days post-surgery. Receives: Other: Electronic Health Record Review; Other: Exercise Intervention; Other: Medical Device Usage and Evaluation; Other: Survey Administration |
| Arm II (usual care) | Active comparator | Patients wear a Fitbit or personal wearable device beginning on day 1 up until day of surgery and then from post-operative day 1 until hospital discharge or until 14 days post-surgery. Receives: Other: Electronic Health Record Review; Other: Medical Device Usage and Evaluation; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative mobility
Will be measured by daily step counts on the Fitbit or personal wearable device. Descriptive summaries of continuous data will include the sample size, group mean, standard deviation, median, and range. Confidence intervals will be included as appropriate. The primary endpoint of daily post-operative step counts will be compared using two sample t-tests between the intervention and control groups.
Measured: Up to day of discharge or 14 days post-operatively, whichever is sooner.
Secondary outcomes (7)
Post-operative complications
Will be derived from the medical chart, and include pneumonia, DVT, ileus, arrhythmia, wound infection and any events requiring ICU transfer. Descriptive statistics will be used to present the results. A two-sample t-test will be used to analyze continuous variables and Chi-square test will be used for categorical variables.
Measured: Up to day of discharge or 14 days post-operatively, whichever is sooner.
Length of stay
Derived from the medical record. Descriptive statistics will be used to present the results. A two-sample t-test will be used to analyze continuous variables and Chi-square test will be used for categorical variables.
Measured: From post-operative day 1 until day of discharge or 14 days post-operatively, whichever is sooner.
Depression
Measured with the Patient Health Questionnaire-9 (PHQ-9) to determine level of depression on the day of discharge. This screening instrument measures the frequency of 9 signs and symptoms diagnostic of depression, with answers as not at all, several days, more than half of the days, and nearly every day. Total scores range between 0-27, and can indicate mild (<4), moderate (5-14), or severe (>20) depression. Descriptive statistics will be used to present the results. A two-sample t-test will be used to analyze continuous variables and Chi-square test will be used for categorical variables.
Measured: Up to day of discharge or 14 days post-operatively, whichever is sooner.
Health-related quality of life
Measured with the European Organization of Research and Treatment of Cancer Quality of Life Core Questionnaire, version 3.0 (EORTC QLQ C30). A 30-item questionnaire to assess overall quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions use 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions use 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged and transformed to 0-100 scale; higher score equates to better level of physical functioning. Descriptive statistics will be used to present the results. A two-sample t-test will be used to analyze continuous variables and Chi-square test will be used for categorical variables.
Measured: Up to day of discharge or 14 days post-operatively, whichever is sooner.
Weight loss
Measured in kg. Weight loss will be determined based on their weight at the time of enrollment at initial pre-operative appointment, compared to their weight on the day of discharge. Descriptive statistics will be used to present the results. A two-sample t-test will be used to analyze continuous variables and Chi-square test will be used for categorical variables.
Measured: From time of enrollment to day of discharge or 14 days post-operatively, whichever is sooner.
Average daily pain scores
Measured on a 1-10 Likert scale, during a patient's inpatient, post-operative stay and obtained from the medical record. Descriptive statistics will be used to present the results. A two-sample t-test will be used to analyze continuous variables and Chi-square test will be used for categorical variables.
Measured: Up to day of discharge or 14 days post-operatively, whichever is sooner.
Discharge Disposition
Derived from the medical record and may include discharge to home, home with assistance, home with home health, skilled nursing facility, inpatient rehabilitation facility or other facility. Descriptive statistics will be used to present the results. A two-sample t-test will be used to analyze continuous variables and Chi-square test will be used for categorical variables.
Measured: At time of discharge or 14 days post-operatively, whichever is sooner.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start1 Feb 2024
- Primary completion15 Jul 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CarcinomaStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Li, MD, OHSU Knight Cancer Institute
- Investigators
- Ryan J Li, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079697
- Sponsor's protocol ID
- STUDY00025357
- Other IDs
- NCI-2023-07171, STUDY00025357
- Status last verified
- Dec 2025
- First submitted
- 28 Sep 2023
- Last updated
- 12 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise Prehabilitation on Post-Operative Recovery After Head and Neck Cancer Surgery
- ClinicalTrials.gov ID
- NCT06079697
- Acronym / sponsor ID
- STUDY00025357
- Conditions
- Head and Neck Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial evaluates a prehabilitation exercise intervention for improving mobility and recovery outcomes in patients undergoing surgery for head and neck cancer. Prehabilitation focuses on optimizing health before surgery in order to improve outcomes after surgery. Prehabilitation may include aspects of nutrition, exercise, mental health, or a combination of these. Exercise has been proven to improve anxiety, depression, fatigue, health related quality of life, and physical function among patients undergoing cancer treatment, as well as cancer survivors. The prehabilitation exercise intervention being studied includes a daily walking program, sit-to-stand training, and standing therapeutic exercises before patients undergo surgery. Receiving this prehabilitation exercise intervention prior to surgery may improve mobility and recovery outcomes in patients after surgery for head and neck cancer.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the impact of an exercise prehabilitation program on post-operative outcomes after head and neck cancer surgery.
SECONDARY OBJECTIVE:
- To evaluate the impact of an exercise prehabilitation program on post-operative weight loss, depression and discharge disposition after head and neck cancer surgery.
EXPLORATORY OBJECTIVES:
- To evaluate the adherence rate to and satisfaction with a pre-operative exercise prehabilitation program, which will be evaluated at the end of their inpatient stay.
II. To evaluate the impact of lower extremity free tissue transfer on post-operative recovery after undergoing an exercise prehabilitation program, which will be evaluated at the end of their inpatient stay.
III. To evaluate the impact of the duration of prehabilitation on post-operative outcomes after head and neck cancer surgery, which will be evaluated at the end of their inpatient stay.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients wear a Fitbit or personal wearable device beginning on day 1 and receive the prehabilitation exercise intervention consisting of 2000-4000 steps per day, sit-to-stand training 3 days per week, and standing therapeutic exercises 3 days per week beginning on day 2 for up to 2-5 weeks prior to surgery. Patients continue wearing the Fitbit personal wearable device from post-operative day 1 until hospital discharge or until 14 days post-surgery.
ARM II: Patients wear a Fitbit personal wearable device beginning on day 1 up until day of surgery and then from post-operative day 1 until hospital discharge or until 14 days post-surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (prehabilitation) | Experimental | Other: Electronic Health Record Review, Other: Exercise Intervention, Other: Medical Device Usage and Evaluation, Other: Survey AdministrationPatients wear a Fitbit or a personal wearable device beginning on day 1 and receive the prehabilitation exercise intervention consisting of 2000-4000 steps per day, sit-to-stand training 3 days per week, and standing therapeutic exercises 3 days per week beginning on day 2 for up to 2-5 weeks prior to surgery. Patients continue wearing the Fitbit or personal wearable device from post-operative day 1 until hospital discharge or until 14 days post-surgery. |
| Arm II (usual care) | Active comparator | Other: Electronic Health Record Review, Other: Medical Device Usage and Evaluation, Other: Survey AdministrationPatients wear a Fitbit or personal wearable device beginning on day 1 up until day of surgery and then from post-operative day 1 until hospital discharge or until 14 days post-surgery. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Older than 18 years of age and younger than 89 years of age. Both men and women and members of all races and ethnic groups may be included
- Planned to undergo major head and neck cancer surgery with free tissue transfer reconstruction at Oregon Health and Science University (OHSU) with the Department of Otolaryngology-Head and Neck Surgery with an expected length of stay (LOS) of 3 days or more
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (11 listed)
- Non-English speaking
- Planned postoperative admission to the intensive care unit (ICU)
- Social or psychiatric conditions that may interfere with compliance
- Further exclusion criteria may be applied due to conditions that may impact the ability to safely exercise as well as utilize the Fitbit devices:
- Symptoms of or ongoing work-up for unstable angina, uncontrolled tachyarrhythmias, decompensated heart failure, severe aortic stenosis, hypertrophic obstructive cardiomyopathy, uncontrolled hypertension (HTN), uncontrolled pulmonary HTN or uncontrolled asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Health Record ReviewAncillary studies | Other | Arm I (prehabilitation), Arm II (usual care) |
| Exercise InterventionReceive prehabilitation exercise intervention | Other | Arm I (prehabilitation) |
| Medical Device Usage and EvaluationWear Fitbits | Other | Arm I (prehabilitation), Arm II (usual care) |
| Survey AdministrationAncillary studies | Other | Arm I (prehabilitation), Arm II (usual care) |
Primary outcome
Post-operative mobility
Time frame: Up to day of discharge or 14 days post-operatively, whichever is sooner.
Will be measured by daily step counts on the Fitbit or personal wearable device. Descriptive summaries of continuous data will include the sample size, group mean, standard deviation, median, and range. Confidence intervals will be included as appropriate. The primary endpoint of daily post-operative step counts will be compared using two sample t-tests between the intervention and control groups.
7 secondary outcomes
Post-operative complications
Time frame: Up to day of discharge or 14 days post-operatively, whichever is sooner.
Length of stay
Time frame: From post-operative day 1 until day of discharge or 14 days post-operatively, whichever is sooner.
Depression
Time frame: Up to day of discharge or 14 days post-operatively, whichever is sooner.
Health-related quality of life
Time frame: Up to day of discharge or 14 days post-operatively, whichever is sooner.
Weight loss
Time frame: From time of enrollment to day of discharge or 14 days post-operatively, whichever is sooner.
Average daily pain scores
Time frame: Up to day of discharge or 14 days post-operatively, whichever is sooner.
Discharge Disposition
Time frame: At time of discharge or 14 days post-operatively, whichever is sooner.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Head and Neck Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan J Li principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Health Record Review, Exercise Intervention and Medical Device Usage and Evaluation in people with Head and Neck Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative mobility (time frame: Up to day of discharge or 14 days post-operatively, whichever is sooner.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.