NCT07622914 The Role of Dietary Fiber in Mitigating Sarcopenia Risk in Head and Neck Cancer
| NCT ID | NCT07622914 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Oklahoma |
| Condition | Head and Neck Cancers |
| Study Type | OBSERVATIONAL |
| Enrollment | 59 participants |
| Start Date | 2025-10-31 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 59 participants in total. It began in 2025-10-31 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Emerging data suggest consumption of dietary fiber before and during cancer treatment may improve prognosis for patients with head and neck cancer, in part via increased production of short chain fatty acids, systemic anti-inflammatory effects, and decreased risk of sarcopenia. Foods rich in dietary fiber are often low in calories and protein, thus are not typically targeted in current treatment paradigms that focus on countering the catabolic state associated with sarcopenia. This project entails an observational, mixed methods study to: observe dietary fiber intake in patients with head and neck cancer from time of diagnosis for six months; elucidate the relationship between dietary fiber intake, short chain fatty acids, inflammatory markers, and sarcopenia; and explore the feasibility of and patient perceptions regarding promoting dietary fiber as part of their treatment approaches.
Eligibility Criteria
Inclusion Criteria: * ≥18 years of age * Newly diagnosed with squamous cell carcinoma of the: paranasal sinuses, nasal cavity, oral cavity, tongue, larynx, pharynx \[i.e., nasopharynx, oropharynx, hypopharynx\] * Meeting at least 60% of baseline energy needs * Willingness to provide data prior to treatment * Access to the internet * Access to a home freezer * Ability to do remote interview * Access to a phone * Willingness to avoid pre-, pro-, or synbiotics Exclusion Criteria: * Previously diagnosed or positive screen for a GI-related condition or eating disorder * Able to complete bioelectrical impedance (stand unsupported, no pacemaker or limb amputation) and Timed Chair Stands * Currently pregnant, planning to become pregnant, or breastfeeding * Current or past 3-month antibiotic use
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07622914 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Cancers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07622914 currently recruiting?
Yes, NCT07622914 is actively recruiting participants. Contact the research team at ashlea-braun@ouhsc.edu for enrollment information.
Where is the NCT07622914 trial being conducted?
This trial is being conducted at Oklahoma City, United States.
Who is sponsoring the NCT07622914 clinical trial?
NCT07622914 is sponsored by University of Oklahoma. The trial plans to enroll 59 participants.
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