Clinical trial · Observational
Monitoring Skeletal Muscle Mass Using CBCT in Patients With H&N Cancer Undergoing Chemoradiotherapy
Monitoring Skeletal Muscle Mass Using Cone-Beam Computed Tomography in Patients With Head and Neck Cancer Undergoing Chemoradiotherapy: Single-center Prospective Study
- 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)
Chemoradiotherapy is the standard treatment for unresectable locally advanced head and neck cancer (HNC). However, malnutrition is present in 44-88% HNC patients during chemoradiotherapy, which leads to loss of skeletal muscle mass (SMM) and poor clinical outcomes. Timely assessment of SMM and early intervention of malnutrition are particularly important for HNC patients undergoing radiotherapy. However, body composition and skeletal muscle loss are not accurately reflected by the current assessment tools of malnutrition, which only measure body mass index and body weight loss. Cone-beam CT (CBCT), a variation of traditional CT, is widely performed to ensure the appropriate position of the patients during radiotherapy. The previous study showed that measuring skeletal muscle areas and its changes using CBCT during radiotherapy is feasible. The hypothesis of this study is loss of SMM is associated with severe adverse effects in HNC patients during radiotherapy compared with body weight loss.
Conditions
Conditions (2)
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 Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Radiotherapy; Adverse Effect | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radical radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Trial cohort
- description
- CBCT: before radiotherapy and once a week during radiotherapy Body weight: before radiotherapy and once a week during radiotherapy The Patient-Generated Subjective Global Assessment (PG-SGA): before radiotherapy, 1st week, 3rd week and the last week during radiotherapy.
- interventionNames
- Radiation: Radical radiotherapy
Primary outcomes (1)
- measure
- The treatment-related severe adverse events
- timeFrame
- 7 weeks
- description
- The association between Loss of SMM and treatment-related severe adverse events including grade 3-4 mucositis, dermatitis, haematological toxicity, interruption of radiotherapy, delayed chemotherapy, and unplanned admission in HNC patients during radiotherapy.
Secondary outcomes (5)
- measure
- The weight loss percentage
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed HNC including Oral Cavity, Oropharyngeal, Nasopharynx, Hypopharyngeal, and Laryngeal Cancers * Clinical stage II-IVa according to the American Joint Committee of Cancer (the seventh edition) * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Exclusion Criteria: * Previous head and neck radiotherapy * Previous cervical lymph node dissection * Active infections * Palliative treatment
References
Publications (0)
Data not yet available