Clinical trial NCT05126095: Monitoring Skeletal Muscle Mass Using CBCT in Patients With H&N Cancer Undergoing Chemoradiotherapy
Official title: Monitoring Skeletal Muscle Mass Using Cone-Beam Computed Tomography in Patients With Head and Neck Cancer Undergoing Chemoradiotherapy: Single-center Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head and Neck Cancer
Radiotherapy; Adverse Effect
Keywords: Cone-beam Computerized tomography
Skeletal Muscle Mass
Body weight
Malnutrition
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with locally advanced HNC scheduled to receive radical radiotherapy

Brief summary: 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.

Detailed description: This is a prospective observational phase II study. Patients with locally advanced HNC scheduled to receive radical radiotherapy are prospectively enrolled in this study. CBCT and body weight are obtained before radiotherapy and once a week during radiotherapy. Severe adverse effects including grade 3-4 mucositis, dermatitis, haematological toxicity, interruption of radiotherapy, delayed chemotherapy, and unplanned admission are recorded during radiotherapy.

Eligibility criteria: 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

Primary outcomes:
measure: The treatment-related severe adverse events
timeFrame: 7 weeks
Secondary outcomes:
measure: The weight loss percentage
timeFrame: 7 weeks
measure: Scored Patient-Generated Subjective Global Assessment (PG-SGA)
timeFrame: 7 weeks
measure: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
timeFrame: 7 weeks
measure: the European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Cancer Module (EORTC QLQ-H&N35)
timeFrame: 7 weeks
measure: Duration ofParenteral nutrition
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: YI PAN
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: YI PAN, Prof.
role: PRINCIPAL_INVESTIGATOR
References: