Monitoring Skeletal Muscle Mass Using CBCT in Patients With H&N Cancer Undergoing Chemoradiotherapy

Head and Neck Cancer Clinical Trial

— MELINOE  

Official title:

Monitoring Skeletal Muscle Mass Using Cone-Beam Computed Tomography in Patients With Head and Neck Cancer Undergoing Chemoradiotherapy: Single-center Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05126095
• Other study ID #: KY-Q-2021-213
• Status: Recruiting
• Start date: November 3, 2021
• Est. completion date: March 30, 2023

Study information

• Verified date: November 2021
• Source: Guangdong Provincial People's Hospital
• Contact: Yi Pan, Prof.
• Phone: +862083827812
• Email: panyiff01[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: March 30, 2023
• Est. primary completion date: June 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Radiation:
• Radical radiotherapy
Intensity-modulated radiation therapy (IMRT)

Locations

Country	Name	City	State
China	YI PAN	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The treatment-related severe adverse events	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.	7 weeks
Secondary	The weight loss percentage	The association between percentage Loss of SMM and weight loss percetage in HNC patients during radiotherapy	7 weeks
Secondary	Scored Patient-Generated Subjective Global Assessment (PG-SGA)	The association between Loss of SMM and PG-SGA in HNC patients during radiotherapy. The PG-SGA scores typically range from 0-35, with a higher score reflecting a greater risk of malnutrition.	7 weeks
Secondary	the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)	The association between Loss of SMM and Quality Of Life in HNC patients during radiotherapy	7 weeks
Secondary	the European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Cancer Module (EORTC QLQ-H&N35)	The association between Loss of SMM and Quality Of Life in HNC patients during radiotherapy	7 weeks
Secondary	Duration ofParenteral nutrition	The association between Loss of SMM and duration of parenteral nutrition in HNC patients during radiotherapy	7 weeks