Recruiting

Dietary Fiber

Sponsor:

University of Oklahoma

Code:

NCT07622914

Conditions

Head and Neck Cancers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT07622914

Start date

Oct 31, 2025

Status verified date

May, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

59 participants

Anticipated

Interventions and Outcome Measures

Arms

Head and neck cancer (HNC) patients

Patients diagnosed with and undergoing treatment for head and neck cancer

Primary outcome measure

  • Dietary Fiber Intake (mean for 30 days) [ Time Frame: Baseline/upon enrollment, 3-months post-enrollment, and 6-months post-enrollment ]
  • Skeletal Muscle Index (SMI) [ Time Frame: Baseline, 3-months post-enrollment, 6-months post-enrollment ]

Central Contacts and Locations

Central contacts

Ashlea C Braun, PhD

15672401582ashlea-braun@ouhsc.edu

Locations

Stephenson Cancer Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Ashlea C Braun, PhD

567-240-1582ashlea-braun@ou.edu

More Information

Sponsor

University of Oklahoma

Last update posted

Jun 3, 2026

Last verified

May, 2026

Keywords

  • Head and neck cancer
  • Diet
  • Sarcopenia
  • Dietary fiber

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2026-06-03.