Exercise Prehabilitation for Head and Neck Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: OHSU Knight Cancer Institute

Disqualifiers: Non-English, ICU admission, psychiatric conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Prehabilitation Exercise Intervention for head and neck cancer?

Research shows that prehabilitation, which includes exercise, can improve fitness and reduce complications before surgery in cancer patients, such as those with lung and oesophageal cancer. This suggests that similar benefits might be seen in head and neck cancer patients. ^{1 2 3 4 5}

Is exercise prehabilitation safe for humans?

Research on exercise prehabilitation, including studies on head and neck cancer patients, shows it is generally safe with no reported adverse effects. It is designed to improve physical function and quality of life before surgery, and studies have not identified any significant safety concerns. ^{1 2 4 6 7}

How is exercise prehabilitation different from other treatments for head and neck cancer?

Exercise prehabilitation is unique because it focuses on improving physical fitness before surgery to enhance recovery and long-term function, unlike traditional treatments that primarily address the cancer itself. This approach includes specific exercise routines designed to optimize neuromuscular function and reduce complications, which is not typically a focus of standard cancer treatments. ^{1 2 4 8 9}

What is the purpose of this trial?

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.

Research Team

Ryan J. Li

Principal Investigator

OHSU Knight Cancer Institute

Eligibility Criteria

This trial is for adults aged 18-89 planning to undergo major head and neck cancer surgery at OHSU, expected to stay for at least 3 days post-op. Participants must understand English, be able to consent, and not require ICU post-op or use assistive walking devices. Those with certain heart conditions, impaired mobility due to falls or metastases, isolation precautions, or cognitive issues affecting technology use cannot join.

Inclusion Criteria

I am scheduled for major head and neck surgery with tissue reconstruction at OHSU and expected to stay for 3+ days.

You possess the capability to comprehend and agree to sign a legally binding informed consent document.

Exclusion Criteria

You have social or mental health conditions that may make it difficult for you to follow the study guidelines.

I am scheduled to stay in the ICU after my surgery.

I need a walker or wheelchair to move around.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants receive a prehabilitation exercise intervention consisting of daily walking, sit-to-stand training, and standing therapeutic exercises for 2-5 weeks prior to surgery

2-5 weeks

Daily exercise sessions

Surgery and Immediate Post-operative

Participants undergo head and neck cancer surgery and are monitored post-operatively with a Fitbit or personal wearable device

Up to 14 days post-surgery

Inpatient stay until discharge

Follow-up

Participants are monitored for post-operative recovery outcomes, including mobility, weight loss, and depression

Up to 14 days post-surgery

Treatment Details

Interventions

• Prehabilitation Exercise Intervention

Trial Overview The study tests a pre-surgery exercise program aimed at improving recovery outcomes in head and neck cancer patients. The program includes daily walks, sit-to-stand exercises, and standing therapeutic exercises designed as prehabilitation before their surgical procedure.

Participant Groups

Group I: Arm I (prehabilitation) Experimental Treatment 4 Interventions

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.

Group II: Arm II (usual care) Active Control 3 Interventions

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.

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute

Lead Sponsor

Trials

239

Recruited

2,089,000+

Findings from Research

A systematic review identified only two studies on nutritional prehabilitation in head and neck cancer patients, both using an 'enriched formula' for malnourished individuals prior to surgery.

The studies found that this enriched nutritional intervention did not significantly improve outcomes such as weight loss, physical function, or surgical complications compared to standard nutritional formulas, highlighting a need for more robust research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional prehabilitation in head and neck cancer: a systematic review. Cantwell, LA., Fahy, E., Walters, ER., et al.[2022]

In a study of 67 oesophageal cancer patients, a personalized pre-operative exercise program helped maintain and even improve cardiorespiratory fitness during neoadjuvant chemotherapy, with significant increases noted just before surgery.

Higher adherence to the exercise program and greater volumes of physical activity were linked to a lower risk of post-operative pneumonia, emphasizing the importance of consistent exercise during prehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Pre-operative Exercise and the Response to Prehabilitation in Oesophageal Cancer Patients. Halliday, LJ., Doganay, E., Wynter-Blyth, V., et al.[2023]

Prehabilitation through high-intensity interval training (HIIT) in lung cancer patients significantly improved cardio-respiratory fitness, with a 14% increase in aerobic capacity and a 20% increase in walking capacity after 8 training sessions.

The study demonstrated that HIIT is feasible for deconditioned patients, with high adherence rates (87%) and measurable improvements in exercise performance, unlike the usual care group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative high-intensity interval training is effective and safe in deconditioned patients with lung cancer: A randomized clinical trial. Bhatia, C., Kayser, B.[2019]

A systematic review of 25 randomized-controlled trials involving 2682 cancer patients found that prehabilitation programs focusing on exercise training did not show clear benefits over usual care in improving health-related quality of life or reducing postoperative complications.

The overall certainty of the evidence was assessed as very low due to serious methodological concerns, indicating that more research is needed to determine the true effectiveness of prehabilitation programs for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation programs for individuals with cancer: a systematic review of randomized-controlled trials. Meneses-Echavez, JF., Loaiza-Betancur, AF., Díaz-López, V., et al.[2023]

In a study of 92 patients with oesophageal cancer, those who participated in a multimodal prehabilitation program had a significantly higher rate of completing their neoadjuvant chemotherapy compared to those who did not receive prehabilitation (p = 0.029).

The results suggest that prehabilitation may enhance patients' tolerance to chemotherapy, indicating a potential benefit for optimizing cancer treatment, although further research is needed to explore its long-term effects on cancer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized Prehabilitation Improves Tolerance to Chemotherapy in Patients with Oesophageal Cancer. Christodoulidis, G., Halliday, LJ., Samara, A., et al.[2023]

A new multiphasic exercise prehabilitation program is being tested for head and neck cancer patients undergoing surgery, aiming to improve physical function and quality of life post-treatment.

The study will assess the safety and feasibility of this exercise intervention, as well as its integration into the surgical care pathway, providing valuable insights into its effectiveness and potential benefits for recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiphasic exercise prehabilitation for patients undergoing surgery for head and neck cancer: a hybrid effectiveness-implementation study protocol. Wagoner, CW., Daun, JT., Danyluk, J., et al.[2023]

This study introduces a prehabilitation program for patients with head and neck cancer, aiming to prevent complications like reduced walking capacity and cervical range of motion, with no adverse effects reported among the three participants involved.

While the results showed mixed outcomes in physical measures, the program highlights the potential role of physical therapists in improving quality of life and managing treatment side effects for cancer patients, indicating a need for further research to validate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Feasibility of a Prehabilitation Protocol for Patients Diagnosed with Head and Neck Cancer. Boright, L., Doherty, DJ., Wilson, CM., et al.[2020]

Prehabilitation programs for head and neck cancer survivors can help improve swallowing function and quality of life, but there is significant variability in how these programs are defined and implemented, with one-third focusing on exercises before treatment and two-thirds during treatment.

Common exercises include the Mendelsohn's maneuver and effortful swallow, typically prescribed at 10 repetitions, three times a day during radiation therapy, but the lack of standardization makes it challenging to determine the most effective approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation in head and neck cancer patients: a literature review. Loewen, I., Jeffery, CC., Rieger, J., et al.[2021]

The study demonstrated that it is feasible to measure patient-reported outcomes (PROs) and in-hospital mobilization in head and neck cancer patients throughout their surgical timeline, with high completion rates for baseline and in-hospital assessments.

However, assessing physical function before surgery proved challenging, indicating a need for improved methods to gather this data, which is crucial for developing effective prehabilitation programs for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of patient-reported outcomes, physical function, and mobilization in the care pathway for head and neck cancer surgical patients. Daun, JT., Twomey, R., Capozzi, LC., et al.[2023]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Nutritional prehabilitation in head and neck cancer: a systematic review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Adherence to Pre-operative Exercise and the Response to Prehabilitation in Oesophageal Cancer Patients. [2023]

3. Sweden pubmed.ncbi.nlm.nih.gov

Preoperative high-intensity interval training is effective and safe in deconditioned patients with lung cancer: A randomized clinical trial. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Prehabilitation programs for individuals with cancer: a systematic review of randomized-controlled trials. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Personalized Prehabilitation Improves Tolerance to Chemotherapy in Patients with Oesophageal Cancer. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Multiphasic exercise prehabilitation for patients undergoing surgery for head and neck cancer: a hybrid effectiveness-implementation study protocol. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Development and Feasibility of a Prehabilitation Protocol for Patients Diagnosed with Head and Neck Cancer. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Prehabilitation in head and neck cancer patients: a literature review. [2021]

9. England pubmed.ncbi.nlm.nih.gov

The feasibility of patient-reported outcomes, physical function, and mobilization in the care pathway for head and neck cancer surgical patients. [2023]