The Role of Dietary Fiber in Mitigating Sarcopenia Risk in Head and Neck Cancer

NCT07622914 | Recruiting

• 1 other identifier: 18719
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancers

Keywords

Head and neck cancer; Diet; Sarcopenia; Dietary fiber

Outcome Measures

Primary Outcomes (2)

• Dietary Fiber Intake (mean for 30 days)

  Reported dietary fiber intake (grams per day) will be measured using the Diet History Questionnaire 3 (DHQ3) to provide a mean value consumed per day over 30 days

  Baseline/upon enrollment, 3-months post-enrollment, and 6-months post-enrollment

• Skeletal Muscle Index (SMI)

  Calculated using skeletal muscle area generated via software-based analysis of CT scans at the mid-third lumbar vertebra (L3) slice and height (in centimeters) as an indicator of sarcopenia (muscle quantity)

  Baseline, 3-months post-enrollment, 6-months post-enrollment

Secondary Outcomes (64)

• Dietary Fiber Intake (daily)

  Baseline, 3-months post-enrollment, 6-months post-enrollment

• Skeletal Muscle Density

  Baseline, 3-months post-enrollment, 6-months post-enrollment

• Intramuscular Adipose Tissue (IMAT)

  Baseline, 3-months post-enrollment, 6-months post-enrollment

• Body Weight

  Baseline, 3-months post-enrollment, 6-months post-enrollment

• Height

  Baseline

Other Outcomes (1)

• Dietary Fiber Intake (mean for past year)

  Measured at baseline only

Study Arms (1)

Head and neck cancer (HNC) patients

Patients diagnosed with and undergoing treatment for head and neck cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults diagnosed with and beginning treatment for head and neck cancer

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and stool samples collected and retained.

MeSH Terms

Conditions

Head and Neck Neoplasms; Sarcopenia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Ashlea C Braun, PhD

CONTACT

15672401582; ashlea-braun@ouhsc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: June 3, 2026
• Study Start: October 31, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: By the end of the project award
• Access Criteria: Openly accessible via OSF

Locations

US (1)