Clinical trial · Observational
The Role of Dietary Fiber in Mitigating Sarcopenia Risk in Head and Neck Cancer
A Preliminary Elucidation of the Role of Dietary Fiber in Mitigating Sarcopenia Risk in Head and Neck Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancers | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Head and neck cancer (HNC) patients
- description
- Patients diagnosed with and undergoing treatment for head and neck cancer
Primary outcomes (2)
- measure
- Dietary Fiber Intake (mean for 30 days)
- timeFrame
- Baseline/upon enrollment, 3-months post-enrollment, and 6-months post-enrollment
- description
- 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
- measure
- Skeletal Muscle Index (SMI)
- timeFrame
- Baseline, 3-months post-enrollment, 6-months post-enrollment
- description
- 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 (64)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available