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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if exercise before surgery can enhance recovery for people with head and neck cancer. Participants in the experimental group will follow a specific exercise plan, including walking, sit-to-stand training, and other exercises before surgery. Those planning to undergo major head and neck cancer surgery and who can walk unaided might be suitable candidates for this trial. As an unphased trial, this study offers participants the chance to contribute to valuable research that could improve recovery outcomes for future patients.

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 prior data suggests that this prehabilitation exercise intervention is safe for patients undergoing surgery for head and neck cancer?

Studies have shown that exercise prehabilitation, which involves preparing the body for surgery through exercise, can be safe and beneficial for people with head and neck cancer. Research suggests that combining exercise with good nutrition can lower the risk of post-surgery complications. For example, one study found a 34% reduction in complications.

These studies often include exercise programs with activities like walking, sit-to-stand exercises, and other simple exercises. Patients typically handle these activities well. The goal is to boost physical fitness and ease recovery after surgery.

In summary, exercise prehabilitation for head and neck cancer patients is not only safe but also helps reduce post-surgery issues, making it a promising option for improving recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how exercise prehabilitation might improve outcomes for head and neck cancer patients. Unlike typical care, which often focuses on post-surgery recovery, this approach emphasizes getting patients physically ready before surgery with a structured exercise plan. The intervention includes walking, sit-to-stand training, and therapeutic exercises, all monitored through wearable devices like Fitbits. This proactive strategy aims to enhance recovery speed and overall health, potentially setting a new standard for surgical preparation in cancer care.

What evidence suggests that this prehabilitation exercise intervention is effective for improving mobility and recovery outcomes in head and neck cancer patients?

Research has shown that exercise before surgery, known as prehabilitation, can greatly improve outcomes for patients undergoing surgery for head and neck cancer. In this trial, some participants will receive a prehabilitation exercise intervention, including activities like walking and strength training to enhance fitness before surgery. Studies have found that these exercise programs can lead to lower mortality rates, fewer serious complications, and shorter hospital stays. This type of program also correlates with better recovery and a higher quality of life after surgery. Regular exercise before surgery may help patients move more easily and recover faster. ^{1 2 3 4 5}

Who Is on the Research Team?

Ryan J. Li

Principal Investigator

OHSU Knight Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11509296/

Head and Neck Cancer (HNC) Prehabilitation - PubMed Central [8] and including 31 articles, prehabilitation significantly decreased mortality rate, serious complication rate, dysphagia rate, and length of hospital stay ( ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38012345/

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

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/hed.27561

Pre‐rehabilitation interventions for patients with head and ... Prehabilitation programs based on exercise, nutrition, or psychoeducation demonstrated improved post-interventional outcomes in HNC.

4. journalotohns.biomedcentral.com journalotohns.biomedcentral.com/articles/10.1186/s40463-020-00486-7

Prehabilitation in head and neck cancer patients: a literature ... This review of the literature has shed light on the variability of prehabilitation timing, exercise type, dose, duration of treatment, and outcomes.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1040842824000933

What is the role of physical exercise in the era of cancer ... Exercise as prehabilitation may have an important role in improving physical fitness, postoperative outcomes, and accelerating recovery.