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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer; Radiotherapy; Adverse Effect
• Intervention / Treatment: Radiation: Radical radiotherapy

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.

• Study Type: Observational
• Enrollment (Anticipated): 135

Contacts and Locations

• Study Contact: Name: Yi Pan, Prof.; Phone Number: 50150 +862083827812; Email: panyiff01@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • YI PAN
      • Contact: YI PAN; Email: panyiff01@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with locally advanced HNC scheduled to receive radical radiotherapy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Trial cohort; 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.	Radiation: Radical radiotherapy; Intensity-modulated radiation therapy (IMRT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The weight loss percentage	The association between percentage Loss of SMM and weight loss percetage in HNC patients during radiotherapy	7 weeks
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
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
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
Duration ofParenteral nutrition	The association between Loss of SMM and duration of parenteral nutrition in HNC patients during radiotherapy	7 weeks

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Investigators: Principal Investigator: YI PAN, Prof., Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 3, 2021
• Primary Completion (ANTICIPATED): June 14, 2022
• Study Completion (ANTICIPATED): March 30, 2023

Study Registration Dates

• First Submitted: November 7, 2021
• First Submitted That Met QC Criteria: November 7, 2021
• First Posted (ACTUAL): November 18, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 2, 2021
• Last Update Submitted That Met QC Criteria: November 21, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Malnutrition; Body weight; Cone-beam Computerized tomography; Skeletal Muscle Mass
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: KY-Q-2021-213

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No