The Role of Dietary Fiber in Mitigating Sarcopenia Risk in Head and Neck Cancer
ConditionHead and Neck Cancers
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Oklahoma
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥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
Disqualifiers
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 population
Adults diagnosed with and beginning treatment for head and neck cancer
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
59 Participants
are grouped into 1 trial groupGroup A: Head and neck cancer (HNC) patients
Trial outcomes
Primary outcomes
1
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-enrollment2
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-enrollmentSecondary outcomes
1
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.
Time frame
Baseline, 3-months post-enrollment, 6-months post-enrollment2
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)
Time frame
Baseline, 3-months post-enrollment, 6-months post-enrollment3
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)
Time frame
Baseline, 3-months post-enrollment, 6-months post-enrollment4
Body Weight
Body weight will be measured in pounds using an InBody scale
Time frame
Baseline, 3-months post-enrollment, 6-months post-enrollmentOther outcomes
1
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
Time frame
Measured at baseline onlySponsors and contacts
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Source ClinicalTrials.gov