The ENHANCE Study: Exercise and Nutrition in Head And Neck CancEr Survivors

Oropharynx Cancer Clinical Trial

Official title:

The ENHANCE Study: Exercise and Nutrition in Head And Neck CancEr Survivors: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05798780
• Other study ID #: MCC-22330
• Status: Recruiting
• Phase: N/A
• Start date: April 6, 2023
• Est. completion date: April 2024

Study information

• Verified date: January 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Sylvia Crowder, PhD
• Phone: 813-745-6849
• Email: Sylvia.Crowder[@]moffitt.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to design a physical activity and dietary intervention for head and neck cancer patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Hypopharynx Cancer
• Laryngeal Neoplasms
• Larynx Cancer
• Mouth Neoplasms
• Oral Cavity Cancer
• Oropharyngeal Neoplasms
• Oropharynx Cancer

Intervention

Behavioral:
• ENHANCE Intervention - Exercise and Nutrition
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.
• ENHANCE Intervention - Nutrition Only
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.

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Recruited - Feasibility	The study will be deemed feasible if = 60% of eligible participants are enrolled	12 Months
Primary	Number of Participants who Complete Questionnaire - Retention - Feasibility	The study will be deemed feasible if = 70% of participants complete post intervention questionnaire.	12 weeks
Primary	Participant Satisfaction of Timeline - Feasibility	The study will be deemed feasible if = 70% of participants like the timing of the intervention using a likert scale (scale range Strongly agree to Strongly disagree)	12 weeks
Primary	Participant Average Attendance - Assessment Completion - Adherence	Participant assessment completion will be deemed successful if participant average attendance is =10 weeks of sessions (out of 12)	12 weeks
Primary	Number of Participants who Complete Task/Goals - Adherence	Study adherence will be deemed successful if =70% of participants report weekly tasks/goals adherence (e.g., gym and diet)	12 weeks
Primary	Participant Satisfaction Assessed with 5 Point Scale - Acceptability	Participants satisfaction will be measured using a 5 point scale (1 is the lowest, 5 is the highest) exit survey administered at the post-intervention follow-up.	12 weeks
Primary	Participant Intent to Continue Assessed with 5 Point Scale - Acceptability	Participants intent to continue will be measured using a 5 point scale (1 is the lowest, 5 is the highest) exit survey administered at the post-intervention follow-up.	12 weeks
Primary	Participant Knowledge Gained Assessed with 5 Point Scale - Acceptability	Participants knowledge gained will be measured using a 5 point scale (1 is the lowest, 5 is the highest) exit survey administered at the post-intervention follow-up.	12 weeks

External Links

•   Moffitt Cancer Center Clinical Trial Search