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Exercise and Nutrition for Head and Neck Cancers

N/A

Recruiting

Led By Sylvia Crowder, PhD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis)

>18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will help develop an exercise and diet plan to improve the health of people with head and neck cancers.

Who is the study for?

The ENHANCE Study is for adults over 18 with new diagnoses of oral, oropharyngeal, hypopharyngeal, or laryngeal cancers. Participants must be able to eat orally, speak and read English, have no major psychiatric disorders, and be cleared for physical activity. They should not be pregnant or scheduled for surgery and must consent to a Mediterranean diet.Check my eligibility

What is being tested?

This study tests an intervention combining exercise with a special diet versus just the dietary change alone in head and neck cancer patients. The goal is to design a program that improves health outcomes by integrating physical activity and nutrition.See study design

What are the potential side effects?

Since this trial focuses on exercise and nutrition rather than medication, side effects may include muscle soreness from physical activity or changes in digestion due to dietary adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have any mental health conditions that would prevent me from participating.

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I am over 18 years old.

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My cancer is newly diagnosed and located in my mouth or throat.

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I am scheduled for radiation or combined chemotherapy and radiation treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants Recruited - Feasibility

Number of Participants who Complete Questionnaire - Retention - Feasibility

Number of Participants who Complete Task/Goals - Adherence

+5 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: ENHANCE Intervention Diet and ExceriseExperimental Treatment1 Intervention

Participants will participate in 2 in-person supervised resistance training sessions every week for the 7 weeks (during radiation), followed by 2 ZOOM video conference supervised resistance training sessions every week for 5 weeks (after radiation). During radiation, participants will be provided 15 meals each week for 7 weeks. Participants will also attend weekly dietary coaching sessions. Participants will receive a Fitbit to wear continuously 24/7 over 12-weeks to track steps and activity intensity.

Group II: ENHANCE Intervention Diet OnlyExperimental Treatment1 Intervention

Participants will be provided 15 meals each week for 7 weeks 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. 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). Participants will receive a Fitbit to wear continuously 24/7 over 12-weeks to track steps and activity intensity.

Group III: Usual Care + FitbitActive Control1 Intervention

Participants will receive handouts with diet and exercise education. Participants will receive a Fitbit to wear continuously 24/7 over 12-weeks to track steps and activity intensity.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

542 Previous Clinical Trials

135,452 Total Patients Enrolled

Sylvia Crowder, PhDPrincipal InvestigatorMoffitt Cancer Center

1 Previous Clinical Trials

40 Total Patients Enrolled

Media Library

ENHANCE Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05798780 — N/A

Oral Cancers Research Study Groups: ENHANCE Intervention Diet and Excerise, ENHANCE Intervention Diet Only, Usual Care + Fitbit

Oral Cancers Clinical Trial 2023: ENHANCE Intervention Highlights & Side Effects. Trial Name: NCT05798780 — N/A

ENHANCE Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05798780 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this trial available to participants yet?

"Affirmative. Clinicaltrials.gov lists this medical trial as being open for recruiting, having been first posted on March 20th of 2023 and last edited April 4th of the same year. 40 people need to be enrolled from a single site."

Answered by AI

What is the aggregate quantity of participants participating in this experiment?

"Affirmative. According to clinicaltrials.gov, this medical trial — which was first posted on March 20th 2021 — is currently recruiting candidates for participation. This experiment necessitates the recruitment of 40 individuals from one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "The ENHANCE Study: Exercise and Nutrition in Head And Neck CancEr Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05798780.