60 Participants Needed

Prehabilitation for Head and Neck Cancer

AN
Overseen ByAkina Natori, MD, MSPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Miami
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the feasibility and benefits of prehabilitation for individuals with head and neck cancer. Prehabilitation includes nutritional guidance and exercise programs before and during cancer treatment to enhance well-being. This study suits those diagnosed with non-spreading head and neck cancer who are about to start radiation or chemoradiation therapy. Participants must not have begun their first treatment within three weeks and need medical clearance to exercise. As an unphased trial, it provides a unique opportunity to contribute to innovative cancer care approaches.

What prior data suggests that this prehabilitation protocol is safe for head and neck cancer patients?

Research has shown that prehabilitation programs, which include exercise and nutritional advice for head and neck cancer patients, are generally safe and well-received. In past studies, most participants reported positive experiences, demonstrating improved physical and mental abilities afterward. Reports from these studies rarely mentioned serious side effects, indicating the programs' safety.

Most reviewed research articles have highlighted positive outcomes from such programs, including improved walking ability, increased oxygen use, and a better quality of life. While safety remains a top priority, current evidence suggests that this prehabilitation approach is both safe and beneficial for patients.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a prehabilitation protocol that combines nutritional counseling and exercise specifically for head and neck cancer patients. Unlike the standard of care, which primarily focuses on treating the cancer with radiation or chemoradiation, this approach aims to improve patients' overall health and resilience before, during, and after treatment. The unique aspect of this protocol is its holistic focus, which might enhance patients' ability to tolerate aggressive cancer therapies and potentially improve their recovery and quality of life.

What evidence suggests that this prehabilitation protocol is effective for head and neck cancer?

Research shows that prehabilitation, which includes exercise and nutritional advice, can reduce the side effects of cancer treatments. Studies have found that even during treatment, prehabilitation aids recovery in head and neck cancer patients. Early results suggest that patients in these programs feel better prepared for treatment and may recover more quickly. This trial will refer participants to a prehabilitation prescription protocol group, focusing on building strength and improving nutrition before and during therapy, which can be crucial for patient outcomes. Overall, evidence supports that prehabilitation positively impacts those undergoing radiotherapy or chemoradiotherapy for head and neck cancer.26789

Who Is on the Research Team?

AN

Akina Natori, MD, MSPH

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with non-metastatic squamous cell carcinoma in the head and neck area, who are scheduled for curative radiation or chemoradiation therapy. They must be able to start prehabilitation before treatment begins, have medical clearance to exercise, not already be highly active, and speak English or Spanish.

Inclusion Criteria

I am planning to undergo radiation or chemoradiation therapy for cancer cure at SCCC, even if I've had surgery.
My cancer is a type of squamous cell carcinoma in the head or neck and has not spread to other parts of my body.
Clearance for exercise by the medical team
See 3 more

Exclusion Criteria

I cannot start the required assessments or pre-treatment before my radiation therapy begins.
I do not speak English or Spanish.
My cancer has spread to other parts of my body.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants receive nutritional counseling and attend exercise programs before and during radiotherapy/chemoradiotherapy treatment

Up to 18 weeks
3 in-person assessments at Baseline, completion of RT/CRT, and 8 weeks post RT/CRT

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Prehabilitation Protocol

Trial Overview

The study tests a 'prehabilitation' program involving nutritional counseling sessions and an exercise regimen for patients with head and neck cancer before they begin radiotherapy/chemoradiotherapy. The goal is to understand patient barriers and preferences regarding these supportive interventions.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Aim 2: Prehabilitation Prescription Protocol GroupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

Citations

Head and Neck Cancer (HNC) Prehabilitation - PubMed Central

In addition, prehabilitation seems to be effective in ameliorating the adverse events of cancer therapies, even when performed during active treatment and, ...

Exercise and Nutritional Prehabilitation for Head and Neck ...

This study examines the acceptability, feasibility, and safety in developing a prehabilitation program for head and neck cancer patients.

Multimodal Prehabilitation in Head and Neck Cancer ...

This study describes the first results of the introduction of multimodal prehabilitation in head and neck cancer surgery patients. This ...

Prehabilitation and rehabilitation guidelines for allied ...

The aim of this review is to give an overview of prehabilitation and rehabilitation guidelines for allied healthcare professionals (AHPs) working in head and ...

Prehabilitation and Recovery After Head and Neck Cancer ...

Support must be expanded to not only help patients survive HNC but to recover faster and live well following surgery. Prehabilitation, or optimizing a patient's ...

Prehabilitation Protocol for Head and Neck Cancer Patients

Prehabilitation in this study means head and neck cancer patients will receive nutritional counseling sessions and attend exercise programs ...

Pre‐rehabilitation interventions for patients with head and ...

Prehabilitation programs based on exercise, nutrition, or psychoeducation demonstrated improved post-interventional outcomes in HNC.

Prehabilitation in head and neck cancer patients

The majority of articles (18 of 19) reviewed reported positive outcomes as a result of prehabilitation programs. While these articles were challenging to ...

Development and Feasibility of a Prehabilitation Protocol ...

These outcomes include functional walking capacity, maximal oxygen consumption (VO2MAX), and QoL.