Head and Neck CancersNCT07622914
The Role of Dietary Fiber in Mitigating Sarcopenia Risk in Head and Neck Cancer
An observational study of Head and Neck Cancers, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancers
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2025to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults diagnosed with and beginning treatment for head and neck cancer
Who may be able to join
- ≥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
Show all 9Show fewer
- Ability to do remote interview
- Access to a phone
- Willingness to avoid pre-, pro-, or synbiotics
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Ashlea C Braun, PhD, 567-240-1582, ashlea-braun@ou.edu
About this study
Official title: A Preliminary Elucidation of the Role of Dietary Fiber in Mitigating Sarcopenia Risk in Head and Neck Cancer
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.
Read the detailed description
Sarcopenia remains a consequential prognostic factor that drastically affects morbidity and mortality in head and neck cancer (HNC). Due to the catabolic state associated with sarcopenia, dietary strategies emphasizing energy and protein intake are often encouraged. However, data suggest underlying mechanisms (e.g., inflammation) drive the development of sarcopenia independent of energy or protein intake. Dietary fiber is notably anti-inflammatory and has capacity to improve sarcopenia and other cancer-related outcomes, in part via production of short chain fatty acids (SCFA) and decreased inflammation. This precise relationship is yet explored in HNC. Moreover, it is unknown how patients perceive the feasibility of increasing their dietary fiber intake during treatment. This study seeks to evaluate dietary fiber intake longitudinally from the time of diagnosis for a total of six months in patients diagnosed with HNC, and to elucidate the relationship between dietary fiber intake and measures of SCFA, inflammation, and sarcopenia. Adults newly diagnosed with HNC will be recruited and provide iterative assessments of dietary fiber intake (National Cancer Institute Diet History Questionnaire III [DHQIII] and 24-hour recalls), SCFA (stool samples analyzed using gas-phase chromatography), inflammatory markers (venous blood samples and multiplex kits), skeletal muscle quantity and quality (CT scans analyzed using SliceOMatic), muscle function (Timed Chair Stands, Leg Press Power), and perceptions regarding the feasibility of targeting dietary fiber (semi-structured interviews [SSIs], surveys). Our central hypothesis is that lower dietary fiber intake will significantly predict development of sarcopenia, decreased SCFA, and increased inflammatory markers. In Aim 1, we will determine the relationship between dietary fiber intake, SCFA, inflammatory markers, and skeletal muscle measures in patients being treated for HNC. In Aim 2, we will characterize the feasibility (acceptability, demand, practicality, implementation) of targeting dietary fiber in patients with HNC according to patient perceptions (SSIs, surveys) within Health Belief Model constructs and review of study records (e.g., retention, completion of data collection). This proposal will generate fundamental knowledge and explore the clinical application of this knowledge to support future clinical trials that have the potential to lead to substantial paradigm shifts that could contribute to immense improvements in HNC prognosis.
- Conditions
- Head and Neck Cancers
- Keywords
- Head and neck cancer, Diet, Sarcopenia, Dietary fiber
- Medical subject headings
- Head and Neck Neoplasms, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Head and neck cancer (HNC) patients | Patients diagnosed with and undergoing treatment for head and neck cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Secondary outcomes (64)
Dietary Fiber Intake (daily)
Reported dietary fiber intake (grams per day) will be measured on two days corresponding to each time point via 24-hour recalls and analyzed using Nutrition Data Systems for Research (NDSR). One meal value will be computed across both days at each time point.
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Skeletal Muscle Density
Mean skeletal muscle density (measured in Hounsfield Units [HU]) will be measured using software-based analysis of CT scans at the mid-third lumbar vertebra (L3) slice as an indicator of sarcopenia (muscle quality)
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Intramuscular Adipose Tissue (IMAT)
Intramuscular Adipose Tissue (IMAT) will be measured in centimeters squared (cm2) using software-based analysis of computed tomography (CT) scans at the mid-third lumbar vertebra (L3) slice as an indicator of sarcopenia (muscle quality)
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Body Weight
Body weight will be measured in pounds using an InBody scale
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Height
Height will be measured in centimers
Measured: Baseline
Fat Free Mass
Fat free mass will be measured in pounds using an InBody scale
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Total Body Water
Total body water will be measured in pounds using an InBody scale
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Skeletal Muscle Mass
Skeletal muscle mass will be measured in pounds using an InBody scale
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Whole Body Phase Angle
Whole body phase angle will be measured in degrees using an InBody scale
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Limb Lean Mass
Limb lean mass will be measured in pounds using an InBody scale
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Limb Intracellular Water
Limb intracellular water will be measured in pounds using an InBody scale
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Limb Extracellular Water
Limb extracellular water will be measured in pounds using an InBody scale
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Limb Phase Angle
Limb phase angle will be measured in degrees using an InBody scale
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Trunk Lean Mass
Trunk lean mass will be measured in pounds using an InBody scale
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Trunk Intracellular Water
Trunk intracellular water will be measured in pounds using an InBody scale
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Trunk Extracellular Water
Trunk extracellular water will be measured in pounds using an InBody scale
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Trunk Phase Angle
Trunk phase angle will be measured in degrees using an InBody scale
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Time Chair Stands (Time)
Timed Chair Stands (TS) done per the National Institutes of Health/National Institute on Aging Short Physical Performance Battery, recorded in seconds
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Time Chair Stands (Pain)
Pain reported during time chair stands will be recorded (Likert scale rating from 0-10)
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Leg Press Power
Leg Press Power (LPP) at 40% and 70% of 1-Repetition Maximum with a Keiser 250 pneumatic leg press. Recorded as power output (Watts) per resistance
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Fecal Short Chain Fatty Acids
Fecal samples collected and analyzed for butyric, valeric acid, propionic acid, acetic acid, and total fatty acids (micromoles per gram [μmol/g]) using gas-phase chromatography
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Self-reported Feasibility of Targeting Dietary Fiber Intake
Feasibility
Measured: Participants will self-report on whether they would be interested in a fiber intervention
Inflammation (platelet-to-lymphocyte ratio [PLR])
From venous blood draws and clinic-assessed complete blood counts
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Neutrophil-to-lymphocyte ratio [NLR])
From venous blood draws and clinic-assessed complete blood counts
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (systemic immune-inflammation index [SII])
From venous blood draws, calculated using neutrophil count multiplied by platelet count and divided by lymphocyte count, from clinic-assessed complete blood counts
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (basophile-to-lymphocyte ratio [BLR)]
From venous blood draws and clinic-assessed complete blood counts
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (monocyte to lymphocyte ratio [MLR])
From venous blood draws and clinic-assessed complete blood counts
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (A proliferation-inducing ligand [APRIL], or tumor necrosis factor ligand superfamily member 13 [TNFSF13])
From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (B-cell activating factor [BAFF]/tumor necrosis factor ligand superfamily member 13B)
From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (soluble CD30/Tumor Necrosis Factor Receptor Superfamily Member 8 [TNFRSF8])
From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Soluble CD163 [sCD163])
From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Chitinase-3-like 1)
From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Glycoprotein 130/Soluble Interleukin-6 Receptor Beta [gp130 / sIL-6Rβ])
From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Interferon alpha-2 [IFN-α2])
From venous blood draws and analyzed via Bio-Rad assay, measured in international units
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Interferon beta [IFN-β])
From venous blood draws and analyzed via Bio-Rad assay, measured in international units per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Interferon gamma [IFN-γ])
From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Interleukin-2 [IL-2])
From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Soluble interleukin-6 receptor alpha [sIL-6Rα])
From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Interleukin-8 [IL-8])
From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Interleukin-10 [IL-10])
From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Interleukin-11 [IL-11])
From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Interleukin-12 p40 subunit (IL-12 [p40]))
From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Interleukin-12 p70 heterodimer (IL-12 [p70]))
From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Interleukin-19 [IL-19])
From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Interleukin-20 [IL-20])
From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Interleukin-22 [IL-22])
From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Interleukin-26 [IL-26])
From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Interleukin-27 p28 subunit [IL-27 (p28)])
From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Interleukin-28A / Interferon lambda-2 [IL-28A / IFN-λ2])
From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Interleukin-29/Interferon lambda-1 [IL-29/IFN-λ1])
From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Interleukin-32 [IL-32])
From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Interleukin-34 [IL-34])
From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Interleukin-35 [IL-35])
From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Tumor necrosis factor superfamily member 14 [LIGHT / TNFSF14])
From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Matrix metalloproteinase-1 [MMP-1])
From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Matrix metalloproteinase-2 [MMP-2])
From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Matrix metalloproteinase-3 [MMP-3])
From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Osteocalcin)
From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Osteopontin)
From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Pentraxin-3 [PTX3])
From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Soluble tumor necrosis factor receptor 1 [sTNF-R1])
From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Soluble tumor necrosis factor receptor 2 [sTNF-R2])
From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Thymic stromal lymphopoietin [TSLP])
From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Tumor necrosis factor-like weak inducer of apoptosis/Tumor necrosis factor superfamily member 12 [TWEAK/TNFSF12])
From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter
Measured: Baseline, 3-months post-enrollment, 6-months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start31 Oct 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancersStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622914
- Sponsor's protocol ID
- 18719
- Status last verified
- May 2026
- First submitted
- 18 Jul 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As able and with participant approval, de-identified data will be deposited into Open Science Framework (OSF)
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Elucidation of the Role of Dietary Fiber in Mitigating Sarcopenia Risk in Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT07622914
- Acronym / sponsor ID
- 18719
- Conditions
- Head and Neck Cancers
- Keywords
- Head and neck cancer, Diet, Sarcopenia, Dietary fiber
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sarcopenia remains a consequential prognostic factor that drastically affects morbidity and mortality in head and neck cancer (HNC). Due to the catabolic state associated with sarcopenia, dietary strategies emphasizing energy and protein intake are often encouraged. However, data suggest underlying mechanisms (e.g., inflammation) drive the development of sarcopenia independent of energy or protein intake. Dietary fiber is notably anti-inflammatory and has capacity to improve sarcopenia and other cancer-related outcomes, in part via production of short chain fatty acids (SCFA) and decreased inflammation. This precise relationship is yet explored in HNC. Moreover, it is unknown how patients perceive the feasibility of increasing their dietary fiber intake during treatment. This study seeks to evaluate dietary fiber intake longitudinally from the time of diagnosis for a total of six months in patients diagnosed with HNC, and to elucidate the relationship between dietary fiber intake and measures of SCFA, inflammation, and sarcopenia. Adults newly diagnosed with HNC will be recruited and provide iterative assessments of dietary fiber intake (National Cancer Institute Diet History Questionnaire III [DHQIII] and 24-hour recalls), SCFA (stool samples analyzed using gas-phase chromatography), inflammatory markers (venous blood samples and multiplex kits), skeletal muscle quantity and quality (CT scans analyzed using SliceOMatic), muscle function (Timed Chair Stands, Leg Press Power), and perceptions regarding the feasibility of targeting dietary fiber (semi-structured interviews [SSIs], surveys). Our central hypothesis is that lower dietary fiber intake will significantly predict development of sarcopenia, decreased SCFA, and increased inflammatory markers. In Aim 1, we will determine the relationship between dietary fiber intake, SCFA, inflammatory markers, and skeletal muscle measures in patients being treated for HNC. In Aim 2, we will characterize the feasibility (acceptability, demand, practicality, implementation) of targeting dietary fiber in patients with HNC according to patient perceptions (SSIs, surveys) within Health Belief Model constructs and review of study records (e.g., retention, completion of data collection). This proposal will generate fundamental knowledge and explore the clinical application of this knowledge to support future clinical trials that have the potential to lead to substantial paradigm shifts that could contribute to immense improvements in HNC prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head and neck cancer (HNC) patients | – | –Patients diagnosed with and undergoing treatment for head and neck cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults diagnosed with and beginning treatment for head and neck cancer
Key inclusion criteria (9 listed)
- ≥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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dietary Fiber Intake (mean for 30 days)
Time frame: Baseline/upon enrollment, 3-months post-enrollment, and 6-months post-enrollment
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
Skeletal Muscle Index (SMI)
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
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)
64 secondary outcomes
Dietary Fiber Intake (daily)
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Skeletal Muscle Density
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Intramuscular Adipose Tissue (IMAT)
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Body Weight
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Height
Time frame: Baseline
Fat Free Mass
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Total Body Water
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Skeletal Muscle Mass
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Whole Body Phase Angle
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Limb Lean Mass
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Limb Intracellular Water
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Limb Extracellular Water
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Limb Phase Angle
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Trunk Lean Mass
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Trunk Intracellular Water
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Trunk Extracellular Water
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Trunk Phase Angle
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Time Chair Stands (Time)
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Time Chair Stands (Pain)
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Leg Press Power
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Fecal Short Chain Fatty Acids
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Self-reported Feasibility of Targeting Dietary Fiber Intake
Time frame: Participants will self-report on whether they would be interested in a fiber intervention
Inflammation (platelet-to-lymphocyte ratio [PLR])
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Neutrophil-to-lymphocyte ratio [NLR])
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (systemic immune-inflammation index [SII])
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (basophile-to-lymphocyte ratio [BLR)]
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (monocyte to lymphocyte ratio [MLR])
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (A proliferation-inducing ligand [APRIL], or tumor necrosis factor ligand superfamily member 13 [TNFSF13])
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (B-cell activating factor [BAFF]/tumor necrosis factor ligand superfamily member 13B)
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (soluble CD30/Tumor Necrosis Factor Receptor Superfamily Member 8 [TNFRSF8])
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Soluble CD163 [sCD163])
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Chitinase-3-like 1)
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Glycoprotein 130/Soluble Interleukin-6 Receptor Beta [gp130 / sIL-6Rβ])
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Interferon alpha-2 [IFN-α2])
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Interferon beta [IFN-β])
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Interferon gamma [IFN-γ])
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Interleukin-2 [IL-2])
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Soluble interleukin-6 receptor alpha [sIL-6Rα])
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Interleukin-8 [IL-8])
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Inflammation (Interleukin-10 [IL-10])
Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: Yes. As able and with participant approval, de-identified data will be deposited into Open Science Framework (OSF)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancers, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashlea C Braun, PhD (15672401582, ashlea-braun@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary Fiber Intake (mean for 30 days) (time frame: Baseline/upon enrollment, 3-months post-enrollment, and 6-months post-enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.