Clinical trial · Observational
The Fibrosis-Lymphedema Continuum 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)
Goal: The primary goal of this study is to longitudinally investigate, in head and neck cancer (HNC) patients, the potential fibrosis-lymphedema continuum. Specifically, we will examine the development, patterns, progression, and prevalence of late-effect fibrosis and/or lymphedema, explore potential biological correlatives including pro-inflammatory cytokines and genetic polymorphisms, and evaluate the relationship among late-effect fibrosis and/or lymphedema and select psychosocial stressors that potentially interact with cytokine pathways. H: A minimum of 20 percent of HNC patients will experience late-effect fibrosis and/or lymphedema. H: We will be able to differentiate characteristics patterns of the development of late-effect fibrosis and/or lymphedema. H: We will be able to differentiate patterns of symptoms associated with late-effect fibrosis and/or lymphedema. H: We will be able to differentiate patterns of inflammatory response and the development of late-effect fibrosis and/or lymphedema. H: Select polymorphisms will increase the likelihood of development of late-effect fibrosis and/or lymphedema. H: Incidence and severity of late-effect fibrosis and/or lymphedema will correlate with total dose of radiation to involved anatomical site. H: HNC patients with fibrosis and/or lymphedema experience greater levels of depression and social withdrawal than those without these conditions.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biomarkers | — | UNRESOLVED | — |
| Depression | — | UNRESOLVED | — |
| Fibrosis | — | UNRESOLVED | — |
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Lymphedema | — | UNRESOLVED | — |
| Polymorphism, Genetic | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Prevelence and nature of fibrosis and/or lymphedema
- timeFrame
- baseline, every six wks. first year pot-tx, and 15 & 18 mths post tx.
- measure
- Relationships among biological mechanisms of fibrosis and/or lymphedema
- timeFrame
- baseline, every 6 weeks after tx. for one year, and 15 and 18 months after tx.
- measure
- Relationship of fibrosis and/or lymphedema and psychosocial stressors
- timeFrame
- baseline, every 6 weeks post tx for 1 year and 15 and 18 months post tx.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * newly diagnosed, histologically proven carcinoma involving the head and neck * Stage II or greater * age of 21 or over * willing and able to undergo baseline and follow-up assessment at the VICC Nashville, or the Nashville Veterans Administration Medical Center (Nashville VA * the ability to speak English Exclusion Criteria: * medical record documentation of cognitive impairment that would preclude the ability to provide informed consent * unwilling to undergo routine follow-up at VICC Nashville or the Nashville VA * recurrent cancer
References
Publications (0)
Data not yet available