ESSI-SURGFeasibility of Early Swallowing and Speech Intervention for Head and Neck Cancer Patients Treated SURGically
ESSI-SURG
+ Standard-of-Care
Deglutition Disorders+6
+ Digestive System Diseases
+ Esophageal Diseases
Prevention Study
Summary
Study start date: December 1, 2023
Actual date on which the first participant was enrolled.Oral cavity cancer is a widespread health issue, with tongue cancer being a particularly common form. People diagnosed with oral cancers often struggle with painful and difficult swallowing, known as dysphagia, which can lead to significant weight loss and other health complications like pneumonia and malnutrition. These swallowing difficulties also greatly affect the quality of life for survivors. Studies suggest that working with speech-language pathologists (SLPs) before issues arise, especially for those undergoing surgery, can be beneficial. Learning strategies to manage swallowing may help reduce complications and the need for feeding tubes, thus improving overall recovery. This study explores the feasibility of starting a clinical trial to evaluate the impact of early speech and swallowing interventions provided by SLPs for patients undergoing surgery for head and neck cancer. Participants will receive guidance from an SLP on how to manage swallowing issues before their surgery. The study will track patients' health and functional outcomes by comparing their condition before treatment and one month afterward. The goal is to understand if early intervention can lead to better health outcomes and improve the overall recovery experience for these patients.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Newly diagnosed patients with at least T2 stage tongue SCC who are planned for partial glossectomy and free flap reconstruction and are anticipated to achieve a post-operative independent oral intake. * Proficient in spoken and written English Exclusion Criteria: * Patients who are planned for total glossectomy
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location