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NCT Number: NCT07622914

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.

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Key information

Conditions

Head and Neck Cancers Atrophy Head and Neck Neoplasms Muscular Atrophy Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location status: Recruiting

Location contact

Ashlea C Braun, PhD

CONTACT

[email protected]

567-240-1582

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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)

Secondary outcomes

  1. Dietary Fiber Intake (daily)

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

    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.

  2. Skeletal Muscle Density

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

    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)

  3. Intramuscular Adipose Tissue (IMAT)

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

    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)

  4. Body Weight

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

    Body weight will be measured in pounds using an InBody scale

  5. Height

    Time frame: Baseline

    Height will be measured in centimers

  6. Fat Free Mass

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

    Fat free mass will be measured in pounds using an InBody scale

  7. Total Body Water

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

    Total body water will be measured in pounds using an InBody scale

  8. Skeletal Muscle Mass

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

    Skeletal muscle mass will be measured in pounds using an InBody scale

  9. Whole Body Phase Angle

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

    Whole body phase angle will be measured in degrees using an InBody scale

  10. Limb Lean Mass

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

    Limb lean mass will be measured in pounds using an InBody scale

  11. Limb Intracellular Water

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

    Limb intracellular water will be measured in pounds using an InBody scale

  12. Limb Extracellular Water

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

    Limb extracellular water will be measured in pounds using an InBody scale

  13. Limb Phase Angle

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

    Limb phase angle will be measured in degrees using an InBody scale

  14. Trunk Lean Mass

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

    Trunk lean mass will be measured in pounds using an InBody scale

  15. Trunk Intracellular Water

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

    Trunk intracellular water will be measured in pounds using an InBody scale

  16. Trunk Extracellular Water

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

    Trunk extracellular water will be measured in pounds using an InBody scale

  17. Trunk Phase Angle

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

    Trunk phase angle will be measured in degrees using an InBody scale

  18. Time Chair Stands (Time)

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

    Timed Chair Stands (TS) done per the National Institutes of Health/National Institute on Aging Short Physical Performance Battery, recorded in seconds

  19. Time Chair Stands (Pain)

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

    Pain reported during time chair stands will be recorded (Likert scale rating from 0-10)

  20. Leg Press Power

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

    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

  21. Fecal Short Chain Fatty Acids

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

    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

  22. Self-reported Feasibility of Targeting Dietary Fiber Intake

    Time frame: Participants will self-report on whether they would be interested in a fiber intervention

    Feasibility

  23. Inflammation (platelet-to-lymphocyte ratio [PLR])

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

    From venous blood draws and clinic-assessed complete blood counts

  24. Inflammation (Neutrophil-to-lymphocyte ratio [NLR])

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

    From venous blood draws and clinic-assessed complete blood counts

  25. Inflammation (systemic immune-inflammation index [SII])

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

    From venous blood draws, calculated using neutrophil count multiplied by platelet count and divided by lymphocyte count, from clinic-assessed complete blood counts

  26. Inflammation (basophile-to-lymphocyte ratio [BLR)]

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

    From venous blood draws and clinic-assessed complete blood counts

  27. Inflammation (monocyte to lymphocyte ratio [MLR])

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

    From venous blood draws and clinic-assessed complete blood counts

  28. 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

    From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter

  29. Inflammation (B-cell activating factor [BAFF]/tumor necrosis factor ligand superfamily member 13B)

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter

  30. Inflammation (soluble CD30/Tumor Necrosis Factor Receptor Superfamily Member 8 [TNFRSF8])

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter

  31. Inflammation (Soluble CD163 [sCD163])

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter

  32. Inflammation (Chitinase-3-like 1)

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter

  33. Inflammation (Glycoprotein 130/Soluble Interleukin-6 Receptor Beta [gp130 / sIL-6Rβ])

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter

  34. Inflammation (Interferon alpha-2 [IFN-α2])

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in international units

  35. Inflammation (Interferon beta [IFN-β])

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in international units per milliliter

  36. Inflammation (Interferon gamma [IFN-γ])

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter

  37. Inflammation (Interleukin-2 [IL-2])

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter

  38. Inflammation (Soluble interleukin-6 receptor alpha [sIL-6Rα])

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter

  39. Inflammation (Interleukin-8 [IL-8])

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter

  40. Inflammation (Interleukin-10 [IL-10])

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter

  41. Inflammation (Interleukin-11 [IL-11])

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter

  42. Inflammation (Interleukin-12 p40 subunit (IL-12 [p40]))

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter

  43. Inflammation (Interleukin-12 p70 heterodimer (IL-12 [p70]))

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter

  44. Inflammation (Interleukin-19 [IL-19])

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter

  45. Inflammation (Interleukin-20 [IL-20])

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter

  46. Inflammation (Interleukin-22 [IL-22])

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter

  47. Inflammation (Interleukin-26 [IL-26])

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter

  48. Inflammation (Interleukin-27 p28 subunit [IL-27 (p28)])

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter

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

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter

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

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter

  51. Inflammation (Interleukin-32 [IL-32])

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter

  52. Inflammation (Interleukin-34 [IL-34])

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter

  53. Inflammation (Interleukin-35 [IL-35])

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter

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

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter

  55. Inflammation (Matrix metalloproteinase-1 [MMP-1])

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter

  56. Inflammation (Matrix metalloproteinase-2 [MMP-2])

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter

  57. Inflammation (Matrix metalloproteinase-3 [MMP-3])

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter

  58. Inflammation (Osteocalcin)

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter

  59. Inflammation (Osteopontin)

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter

  60. Inflammation (Pentraxin-3 [PTX3])

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter

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

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter

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

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter

  63. Inflammation (Thymic stromal lymphopoietin [TSLP])

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

    From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter

  64. 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

    From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter

Other outcomes

  1. Dietary Fiber Intake (mean for past year)

    Time frame: Measured at baseline only

    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 the past year, prior to diagnosis

Study contacts

Contact information is provided by the study sponsor or research team.

Ashlea C Braun, PhD

CONTACT

[email protected]

15672401582

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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