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Trial Title:
The ENHANCE Study: Exercise and Nutrition in Head And Neck CancEr Survivors
NCT ID:
NCT05798780
Condition:
Oral Cavity Cancer
Oropharynx Cancer
Hypopharynx Cancer
Larynx Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Mouth Neoplasms
Oropharyngeal Neoplasms
Laryngeal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
ENHANCE Intervention - Exercise and Nutrition
Description:
During radiation, participants will attend in-person supervised resistance training
sessions once a week for 7 weeks, followed by 2 ZOOM video conference supervised
resistance training sessions every week for 5 weeks, after radiation. Sessions will last
approximately 30 minutes. During radiation, participants will be provided 15 meals each
week for 7 weeks, 105 meals total. Participants will be asked to participate in 1 weekly
dietary coaching session (in-person during radiation and video conference following
radiation), create weekly SMART goals, follow an alternative Mediterranean diet pattern,
and log all meals, snacks, and supplements consumed for the 12-week intervention.
Arm group label:
ENHANCE Intervention Diet and Excerise
Intervention type:
Behavioral
Intervention name:
ENHANCE Intervention - Nutrition Only
Description:
During chemoradiotherapy, participants will be provided 15 meals each week for 7 weeks
(105 meals total) that will accommodate common NIS concerns (ex. dysphagia and difficulty
chewing) following an aMED dietary pattern (5 breakfast, 5 lunch, and 5 dinner), will be
taught proper portion size, and will be asked to record percentages of each meal consumed
in a provided food journal, in addition to any outside meals, snacks, or nutritional
supplements. They will be provided with dietary coaching weekly to discuss NIS, aMED diet
compliance, and set weekly SMART goals (approximately 30 min). Following completion of
chemoradiotherapy (5 weeks), participants will be provided dietary coaching weekly
(in-person or via videoconference), discuss NIS, aMED diet compliance at home, and set
weekly SMART goals (30 min). Trainers will monitor participants' Fitbit active minutes in
real time throughout the intervention period and provide aerobic exercise encouragement
accordingly.
Arm group label:
ENHANCE Intervention Diet Only
Summary:
The purpose of the study is to design a physical activity and dietary intervention for
head and neck cancer patients.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- >18 years old
- Newly diagnosed tumors of the oral cavity, oropharynx, hypopharynx, or larynx
- No documented or observable psychiatric or neurological disorders that would
interfere with study participation (e.g., dementia, psychosis)
- Able to speak and read English
- Able to consume food orally
- Willing to consume an alternative Mediterranean diet
- Scheduled to receive treatment with radiation or chemoradiation
- Screened via the Physical Activity Readiness Questionnaire (PAR-Q+) with medical
clearance of treating physicians, as necessary
- Able to provide informed consent
Exclusion Criteria:
- Women who are pregnant
- Head and Neck Cancer not the primary diagnosis
- Patients scheduled to receive surgery
- Patients on enteral or parental nutrition
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Crystal Bryant
Phone:
813-745-2168
Email:
Crystal.Bryant@moffitt.org
Investigator:
Last name:
Sylvia Crowder, PhD
Email:
Principal Investigator
Investigator:
Last name:
Nathan Parker, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Heather Jim, PhD
Email:
Sub-Investigator
Investigator:
Last name:
James Caudell, MD
Email:
Sub-Investigator
Investigator:
Last name:
Kedar Kirtane, MD
Email:
Sub-Investigator
Investigator:
Last name:
Bob Gore, PhD
Email:
Sub-Investigator
Start date:
April 6, 2023
Completion date:
January 2025
Lead sponsor:
Agency:
H. Lee Moffitt Cancer Center and Research Institute
Agency class:
Other
Source:
H. Lee Moffitt Cancer Center and Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05798780
https://moffitt.org/clinicaltrialssearch?DiseaseSite=&q=22330
