Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Head and neck cancer (HNC) patients | Patients diagnosed with and undergoing treatment for head and neck cancer |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) | Baseline, 3-months post-enrollment, 6-months post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3-months post-enrollment, 6-months post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary Fiber Intake (mean for past year) | 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 | Measured at baseline only |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Adults diagnosed with and beginning treatment for head and neck cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashlea C Braun, PhD | Contact | 15672401582 | ashlea-braun@ouhsc.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stephenson Cancer Center | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
As able and with participant approval, de-identified data will be deposited into Open Science Framework (OSF)
By the end of the project award
Openly accessible via OSF
Not provided
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
Not provided
Not provided
Not provided
Not provided
Not provided
Blood and stool samples collected and retained.
| 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) | 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) | Baseline, 3-months post-enrollment, 6-months post-enrollment |
| Body Weight | Body weight will be measured in pounds using an InBody scale | Baseline, 3-months post-enrollment, 6-months post-enrollment |
| Height | Height will be measured in centimers | Baseline |
| Fat Free Mass | Fat free mass will be measured in pounds using an InBody scale | Baseline, 3-months post-enrollment, 6-months post-enrollment |
| Total Body Water | Total body water will be measured in pounds using an InBody scale | Baseline, 3-months post-enrollment, 6-months post-enrollment |
| Skeletal Muscle Mass | Skeletal muscle mass will be measured in pounds using an InBody scale | 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 | Baseline, 3-months post-enrollment, 6-months post-enrollment |
| Limb Lean Mass | Limb lean mass will be measured in pounds using an InBody scale | Baseline, 3-months post-enrollment, 6-months post-enrollment |
| Limb Intracellular Water | Limb intracellular water will be measured in pounds using an InBody scale | Baseline, 3-months post-enrollment, 6-months post-enrollment |
| Limb Extracellular Water | Limb extracellular water will be measured in pounds using an InBody scale | Baseline, 3-months post-enrollment, 6-months post-enrollment |
| Limb Phase Angle | Limb phase angle will be measured in degrees using an InBody scale | Baseline, 3-months post-enrollment, 6-months post-enrollment |
| Trunk Lean Mass | Trunk lean mass will be measured in pounds using an InBody scale | Baseline, 3-months post-enrollment, 6-months post-enrollment |
| Trunk Intracellular Water | Trunk intracellular water will be measured in pounds using an InBody scale | Baseline, 3-months post-enrollment, 6-months post-enrollment |
| Trunk Extracellular Water | Trunk extracellular water will be measured in pounds using an InBody scale | Baseline, 3-months post-enrollment, 6-months post-enrollment |
| Trunk Phase Angle | Trunk phase angle will be measured in degrees using an InBody scale | 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 | 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) | 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 | 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 | Baseline, 3-months post-enrollment, 6-months post-enrollment |
| Self-reported Feasibility of Targeting Dietary Fiber Intake | Feasibility | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Baseline, 3-months post-enrollment, 6-months post-enrollment |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |