Head and Neck Cancers
Conditions
Keywords
Head and neck cancer, Diet, Sarcopenia, Dietary fiber
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.
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.
Interventions
None listed
Sponsors
University of Oklahoma
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dietary Fiber Intake (mean for 30 days) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Dietary Fiber Intake (daily) | 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. |
| Skeletal Muscle Density | 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) |
| Intramuscular Adipose Tissue (IMAT) | 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) |
| Body Weight | Baseline, 3-months post-enrollment, 6-months post-enrollment | Body weight will be measured in pounds using an InBody scale |
| Height | Baseline | Height will be measured in centimers |
| Fat Free Mass | Baseline, 3-months post-enrollment, 6-months post-enrollment | Fat free mass will be measured in pounds using an InBody scale |
| Total Body Water | Baseline, 3-months post-enrollment, 6-months post-enrollment | Total body water will be measured in pounds using an InBody scale |
| Skeletal Muscle Mass | Baseline, 3-months post-enrollment, 6-months post-enrollment | Skeletal muscle mass will be measured in pounds using an InBody scale |
| Whole Body Phase Angle | Baseline, 3-months post-enrollment, 6-months post-enrollment | Whole body phase angle will be measured in degrees using an InBody scale |
| Limb Lean Mass | Baseline, 3-months post-enrollment, 6-months post-enrollment | Limb lean mass will be measured in pounds using an InBody scale |
| Limb Intracellular Water | Baseline, 3-months post-enrollment, 6-months post-enrollment | Limb intracellular water will be measured in pounds using an InBody scale |
| Limb Extracellular Water | Baseline, 3-months post-enrollment, 6-months post-enrollment | Limb extracellular water will be measured in pounds using an InBody scale |
| Limb Phase Angle | Baseline, 3-months post-enrollment, 6-months post-enrollment | Limb phase angle will be measured in degrees using an InBody scale |
| Trunk Lean Mass | Baseline, 3-months post-enrollment, 6-months post-enrollment | Trunk lean mass will be measured in pounds using an InBody scale |
| Trunk Intracellular Water | Baseline, 3-months post-enrollment, 6-months post-enrollment | Trunk intracellular water will be measured in pounds using an InBody scale |
| Trunk Extracellular Water | Baseline, 3-months post-enrollment, 6-months post-enrollment | Trunk extracellular water will be measured in pounds using an InBody scale |
| Trunk Phase Angle | Baseline, 3-months post-enrollment, 6-months post-enrollment | Trunk phase angle will be measured in degrees using an InBody scale |
| Time Chair Stands (Time) | 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 |
| Time Chair Stands (Pain) | Baseline, 3-months post-enrollment, 6-months post-enrollment | Pain reported during time chair stands will be recorded (Likert scale rating from 0-10) |
| Leg Press Power | 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 |
| Fecal Short Chain Fatty Acids | 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 |
| Self-reported Feasibility of Targeting Dietary Fiber Intake | Participants will self-report on whether they would be interested in a fiber intervention | Feasibility |
| Inflammation (platelet-to-lymphocyte ratio [PLR]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and clinic-assessed complete blood counts |
| Inflammation (Neutrophil-to-lymphocyte ratio [NLR]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and clinic-assessed complete blood counts |
| Inflammation (systemic immune-inflammation index [SII]) | 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 |
| Inflammation (basophile-to-lymphocyte ratio [BLR)] | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and clinic-assessed complete blood counts |
| Inflammation (monocyte to lymphocyte ratio [MLR]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and clinic-assessed complete blood counts |
| Inflammation (A proliferation-inducing ligand [APRIL], or tumor necrosis factor ligand superfamily member 13 [TNFSF13]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter |
| Inflammation (B-cell activating factor [BAFF]/tumor necrosis factor ligand superfamily member 13B) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter |
| Inflammation (soluble CD30/Tumor Necrosis Factor Receptor Superfamily Member 8 [TNFRSF8]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter |
| Inflammation (Soluble CD163 [sCD163]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter |
| Inflammation (Chitinase-3-like 1) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter |
| Inflammation (Glycoprotein 130/Soluble Interleukin-6 Receptor Beta [gp130 / sIL-6Rβ]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter |
| Inflammation (Interferon alpha-2 [IFN-α2]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in international units |
| Inflammation (Interferon beta [IFN-β]) | 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 |
| Inflammation (Interferon gamma [IFN-γ]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter |
| Inflammation (Interleukin-2 [IL-2]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter |
| Inflammation (Soluble interleukin-6 receptor alpha [sIL-6Rα]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter |
| Inflammation (Interleukin-8 [IL-8]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter |
| Inflammation (Interleukin-10 [IL-10]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter |
| Inflammation (Interleukin-11 [IL-11]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter |
| Inflammation (Interleukin-12 p40 subunit (IL-12 [p40])) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter |
| Inflammation (Interleukin-12 p70 heterodimer (IL-12 [p70])) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter |
| Inflammation (Interleukin-19 [IL-19]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter |
| Inflammation (Interleukin-20 [IL-20]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter |
| Inflammation (Interleukin-22 [IL-22]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter |
| Inflammation (Interleukin-26 [IL-26]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter |
| Inflammation (Interleukin-27 p28 subunit [IL-27 (p28)]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter |
| Inflammation (Interleukin-28A / Interferon lambda-2 [IL-28A / IFN-λ2]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter |
| Inflammation (Interleukin-29/Interferon lambda-1 [IL-29/IFN-λ1]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter |
| Inflammation (Interleukin-32 [IL-32]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter |
| Inflammation (Interleukin-34 [IL-34]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter |
| Inflammation (Interleukin-35 [IL-35]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter |
| Inflammation (Tumor necrosis factor superfamily member 14 [LIGHT / TNFSF14]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter |
| Inflammation (Matrix metalloproteinase-1 [MMP-1]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter |
| Inflammation (Matrix metalloproteinase-2 [MMP-2]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter |
| Inflammation (Matrix metalloproteinase-3 [MMP-3]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter |
| Inflammation (Osteocalcin) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter |
| Inflammation (Osteopontin) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter |
| Inflammation (Pentraxin-3 [PTX3]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter |
| Inflammation (Soluble tumor necrosis factor receptor 1 [sTNF-R1]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in nanograms per milliliter |
| Inflammation (Soluble tumor necrosis factor receptor 2 [sTNF-R2]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter |
| Inflammation (Thymic stromal lymphopoietin [TSLP]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter |
| Inflammation (Tumor necrosis factor-like weak inducer of apoptosis/Tumor necrosis factor superfamily member 12 [TWEAK/TNFSF12]) | Baseline, 3-months post-enrollment, 6-months post-enrollment | From venous blood draws and analyzed via Bio-Rad assay, measured in picograms per milliliter |
Countries
United States
Contacts
CONTACTAshlea C Braun, PhD
Outcome results
None listed