The Role of Dietary Fiber in Mitigating Sarcopenia Risk in Head and Neck Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Head and Neck Cancers. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Preliminary Elucidation of the Role of Dietary Fiber in Mitigating Sarcopenia Risk in Head and Neck Cancer
Overview
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.
Primary outcome measures
- Dietary Fiber Intake (mean for 30 days) [Time frame: Baseline/upon enrollment, 3-months post-enrollment, and 6-months post-enrollment]
- Skeletal Muscle Index (SMI) [Time frame: Baseline, 3-months post-enrollment, 6-months post-enrollment]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Stephenson Cancer Center — Oklahoma City
Identifiers
NCT: NCT07622914 · 18719