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RecruitingObservational

A Preliminary Elucidation of the Role of Dietary Fiber in Mitigating Sarcopenia Risk in Head and Neck Cancer

NCT ID: NCT07622914Sponsor: University of OklahomaLast updated: 2026-06-03

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.

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.

Arms & interventions

Outcome measures

Primary

  • 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

    Time frame: 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)

    Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment

Secondary

  • 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

  • Inflammation (Interleukin-11 [IL-11])

    Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment

  • Inflammation (Interleukin-12 p40 subunit (IL-12 [p40]))

    Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment

  • Inflammation (Interleukin-12 p70 heterodimer (IL-12 [p70]))

    Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment

  • Inflammation (Interleukin-19 [IL-19])

    Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment

  • Inflammation (Interleukin-20 [IL-20])

    Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment

  • Inflammation (Interleukin-22 [IL-22])

    Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment

  • Inflammation (Interleukin-26 [IL-26])

    Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment

  • Inflammation (Interleukin-27 p28 subunit [IL-27 (p28)])

    Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment

  • Inflammation (Interleukin-28A / Interferon lambda-2 [IL-28A / IFN-λ2])

    Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment

  • Inflammation (Interleukin-29/Interferon lambda-1 [IL-29/IFN-λ1])

    Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment

  • Inflammation (Interleukin-32 [IL-32])

    Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment

  • Inflammation (Interleukin-34 [IL-34])

    Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment

  • Inflammation (Interleukin-35 [IL-35])

    Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment

  • Inflammation (Tumor necrosis factor superfamily member 14 [LIGHT / TNFSF14])

    Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment

  • Inflammation (Matrix metalloproteinase-1 [MMP-1])

    Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment

  • Inflammation (Matrix metalloproteinase-2 [MMP-2])

    Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment

  • Inflammation (Matrix metalloproteinase-3 [MMP-3])

    Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment

  • Inflammation (Osteocalcin)

    Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment

  • Inflammation (Osteopontin)

    Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment

  • Inflammation (Pentraxin-3 [PTX3])

    Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment

  • Inflammation (Soluble tumor necrosis factor receptor 1 [sTNF-R1])

    Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment

  • Inflammation (Soluble tumor necrosis factor receptor 2 [sTNF-R2])

    Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment

  • Inflammation (Thymic stromal lymphopoietin [TSLP])

    Time frame: 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])

    Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104

Recruiting
Ashlea C Braun, PhD · Contact
567-240-1582ashlea-braun@ou.edu