Back to resultsEarly Feeding After Oral Cavity Reconstruction
Primary Purpose
Head and Neck Cancer, Free Tissue Transfer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early Feeding
Sponsored by
About this trial
This is an interventional supportive care trial for Head and Neck Cancer focused on measuring Oral Cavity Cancer, Oral Cavity Reconstruction, Early Postoperative Feeding, Orocutaneous Fistula, Salivary Leak
Eligibility Criteria
Inclusion Criteria
- Patients receiving free tissue transfer regardless of the indication for oral cavity reconstruction will be included.
- Age ≥ 18 years.
- English, Spanish, and Chinese (Mandarin) speaking patients
- Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria
- Patients having undergone prior major oral cavity surgery or radiation to the oral cavity (also known as surgical salvage patients).
- Patients with a known history of dysphagia or with current enteral feeding needs
- Patients with a history of traumatic brain injury, stroke, or dementia
- Patients unable to understand the research protocol and/or provide informed consent. The consent will be translated into English, Spanish, and Chinese (Mandarin). Given patient demographics at Mount Sinai Hospital, this will include the overwhelming majority of patients.
- Patients under the age of 18
- Patients whose participation in this trial would require exclusion from participation in another clinical research trial related to the patient's malignant diagnosis.
- Vulnerable populations (adults unable to consent, individuals who are not yet adults, wards of the state, pregnant women, prisoners, pregnant women)
Sites / Locations
- Mount Sinai Health SystemRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Early Feeding Arm
Arm Description
Early Feeding Group
Outcomes
Primary Outcome Measures
Incidence of Orocutaneous Fistula
Orocutaneous Salivary Fistula Formation - An orocutaneous fistula or salivary leak is a wound complication that results when saliva or other liquids leak from the mouth through the skin of the face or neck. The subject's oral cavity and neck will be monitored in the standard fashion for development of orocutaneous fistula. The oral cavity will be monitored daily for signs of wound breakdown. The neck will be examined for redness, tenderness to palpation, or increased swelling. Additionally, systemic signs of fistula formation will be monitored such as leukocytosis and fever.
Secondary Outcome Measures
Incidence of Surgical Site Infection
Surgical site infection is defined clinically as fever, erythema, swelling or purulent drainage from the surgical site requiring topical or systemic treatment.
Incidence of Wound Dehiscence
Wound dehiscence is defined as the breakdown at the surgical site with or without intervention.
Rate of PO tolerance
The proportion of patients that are cleared for a diet by the speech language pathology team.
Incidence of Aspiration pneumonia
Aspiration pneumonia is defined clinically based on vital signs, respiratory secretions, and chest x-ray findings indicating pneumonia requiring antibiotic treatment.
Length of hospital stay
Length of hospital stay is defined as the days from admission to discharge.
Jaw range of motion
Bedside swallow evaluation outcomes include jaw Jaw Range of Motion opening which will be measured in millimeters using the Therabite measuring tool and fingers, ranges from 0, indicating <1, to 5, indicating 3 or greater.
Tongue range of motion
Bedside swallow evaluation outcomes include tongue range of motion. Tongue Range of Motion Scale will be measured in millimeters, with a range of 100-0, 100 indicating full tongue range of motion and 0 indication no tongue movement.
MD Anderson Dysphagia Index (MDADI)
MD Anderson Dysphagia Index (MDADI) is a survey designed to assess a subject's perception of his or her swallowing ability. Patient responds to questionnaire that best reflects their current experience, ranges from Strongly Agree to Strongly Disagree. The scores range from a minimum of 0 to a max of 100, with higher scores indicating higher functioning.
Performance Status Scale for Head and Neck Cancer (PSS-HN)
Performance Status Scale for Head and Neck Cancer (PSS-HN) is a survey aimed at evaluating performance and function with regard to eating, speaking, and eating in public. Subscales provide a range of 100 - No restrictions and full understandability to 0 - Full restrictions and no understandability. Subscales are scored individually with higher scores indicating better performance.
Full Information
NCT ID
NCT04787939
First Posted
March 4, 2021
Last Updated
April 23, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT04787939
Brief Title
Early Feeding After Oral Cavity Reconstruction
Official Title
Early Feeding After Free Flap Reconstruction of Oral Cavity Defects: A Single Arm Non-inferiority Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2021 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a prospective single-arm non-inferiority trial evaluating surgical outcomes in subjects who are fed in the first days after oral cavity reconstructive surgery. The purpose of the study is to specifically compare the rates of orocutaneous fistula in subjects who are allowed to eat immediately after surgery to those rates published in the literature (individuals for whom oral feeding is delayed for several days after surgery). Eighty nine subjects who will undergo oral cavity reconstructive surgery will be enrolled between Mount Sinai Hospital and Mount Sinai West. Study participation will last for 30 days after surgery during which time patients will be examined for any signs or symptoms of surgical site infection or wound breakdown, have several clinical evaluations of swallow function, and be asked to report on several patient reported outcome measures.
Detailed Description
In this single-arm non-inferiority study, the study team will aim to evaluate the safety of early feeding in patients with oral cavity reconstruction who are allowed to eat by mouth on post-operative day 1. Traditionally, surgeons have opted to delay the time to oral feeding in oral cavity reconstruction because of concern that an early oral diet may stress intraoral suture lines and lead to the development of salivary leaks. However, evidence from small studies evaluating oral feeding timing in patients who underwent total laryngectomy suggests that there is no increased risk associated with early oral feeding. As such, the study team will aim to determine whether early feeding on postoperative day 1 is non-inferior with respect to the development of orocutaneous fistula to the standard care as described in the literature. There are roughly 50-60 oral cavity reconstructive surgeries performed at Mount Sinai each year - as such it is not feasible to recruit two study arms for direct comparison.
In addition to salivary leak rates, the study team will report outcomes related to the cohort's wound healing, length of time in the hospital, length of time requiring an enteral tube feeds, swallow evaluation information, and the results of patient reported outcomes measures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Free Tissue Transfer
Keywords
Oral Cavity Cancer, Oral Cavity Reconstruction, Early Postoperative Feeding, Orocutaneous Fistula, Salivary Leak
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The study is a single arm non-inferiority study evaluating wound healing outcomes (orocutaneous fistula, salivary leak, wound dehiscence) in subjects undergoing free tissue transfer for oral cavity reconstruction who are permitted to drink liquids by mouth on postoperative day 1. Outcomes are tracked and assessed over a 30 day period postoperatively.
Masking
None (Open Label)
Allocation
N/A
Enrollment
89 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early Feeding Arm
Arm Type
Experimental
Arm Description
Early Feeding Group
Intervention Type
Behavioral
Intervention Name(s)
Early Feeding
Intervention Description
Subjects will be permitted to drink liquids by mouth on the first day after surgery. Outcomes related to their care, wound healing, and quality of life will be followed for 30 days after surgery.
Primary Outcome Measure Information:
Title
Incidence of Orocutaneous Fistula
Description
Orocutaneous Salivary Fistula Formation - An orocutaneous fistula or salivary leak is a wound complication that results when saliva or other liquids leak from the mouth through the skin of the face or neck. The subject's oral cavity and neck will be monitored in the standard fashion for development of orocutaneous fistula. The oral cavity will be monitored daily for signs of wound breakdown. The neck will be examined for redness, tenderness to palpation, or increased swelling. Additionally, systemic signs of fistula formation will be monitored such as leukocytosis and fever.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Incidence of Surgical Site Infection
Description
Surgical site infection is defined clinically as fever, erythema, swelling or purulent drainage from the surgical site requiring topical or systemic treatment.
Time Frame
30 days
Title
Incidence of Wound Dehiscence
Description
Wound dehiscence is defined as the breakdown at the surgical site with or without intervention.
Time Frame
30 days
Title
Rate of PO tolerance
Description
The proportion of patients that are cleared for a diet by the speech language pathology team.
Time Frame
30 days
Title
Incidence of Aspiration pneumonia
Description
Aspiration pneumonia is defined clinically based on vital signs, respiratory secretions, and chest x-ray findings indicating pneumonia requiring antibiotic treatment.
Time Frame
30 days
Title
Length of hospital stay
Description
Length of hospital stay is defined as the days from admission to discharge.
Time Frame
30 days
Title
Jaw range of motion
Description
Bedside swallow evaluation outcomes include jaw Jaw Range of Motion opening which will be measured in millimeters using the Therabite measuring tool and fingers, ranges from 0, indicating <1, to 5, indicating 3 or greater.
Time Frame
30 days
Title
Tongue range of motion
Description
Bedside swallow evaluation outcomes include tongue range of motion. Tongue Range of Motion Scale will be measured in millimeters, with a range of 100-0, 100 indicating full tongue range of motion and 0 indication no tongue movement.
Time Frame
30 days
Title
MD Anderson Dysphagia Index (MDADI)
Description
MD Anderson Dysphagia Index (MDADI) is a survey designed to assess a subject's perception of his or her swallowing ability. Patient responds to questionnaire that best reflects their current experience, ranges from Strongly Agree to Strongly Disagree. The scores range from a minimum of 0 to a max of 100, with higher scores indicating higher functioning.
Time Frame
30 Days
Title
Performance Status Scale for Head and Neck Cancer (PSS-HN)
Description
Performance Status Scale for Head and Neck Cancer (PSS-HN) is a survey aimed at evaluating performance and function with regard to eating, speaking, and eating in public. Subscales provide a range of 100 - No restrictions and full understandability to 0 - Full restrictions and no understandability. Subscales are scored individually with higher scores indicating better performance.
Time Frame
30 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patients receiving free tissue transfer regardless of the indication for oral cavity reconstruction will be included.
Age ≥ 18 years.
English, Spanish, and Chinese (Mandarin) speaking patients
Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria
Patients having undergone prior major oral cavity surgery or radiation to the oral cavity (also known as surgical salvage patients).
Patients with a known history of dysphagia or with current enteral feeding needs
Patients with a history of traumatic brain injury, stroke, or dementia
Patients unable to understand the research protocol and/or provide informed consent. The consent will be translated into English, Spanish, and Chinese (Mandarin). Given patient demographics at Mount Sinai Hospital, this will include the overwhelming majority of patients.
Patients under the age of 18
Patients whose participation in this trial would require exclusion from participation in another clinical research trial related to the patient's malignant diagnosis.
Vulnerable populations (adults unable to consent, individuals who are not yet adults, wards of the state, pregnant women, prisoners, pregnant women)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rocco Ferrandino, MD
Phone
(212) 844-8775
Email
Rocco.ferrandino@mountsinai.org
First Name & Middle Initial & Last Name or Official Title & Degree
Catharine Kappauf, MD
Email
catharine.kappauf@mountsinai.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohemmed Khan, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Health System
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohemmed Khan, MD
Phone
212-844-8775
Email
mohemmed.khan@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Mohemmed Khan, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Early Feeding After Oral Cavity Reconstruction
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