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

• Sponsor: Guangdong Provincial People's Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05126095
• Collaborator: (none)
• Enrollment: 135
• Location: 1
• Anticipated Duration (Months): 16.8
• Patients Per Site Per Month: 8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer; Radiotherapy; Adverse Effect	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 Design

• Study Type: Observational
• Anticipated Enrollment: 135 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Monitoring Skeletal Muscle Mass Using Cone-Beam Computed Tomography in Patients With Head and Neck Cancer Undergoing Chemoradiotherapy: Single-center Prospective Study
• Actual Study Start Date: Nov 3, 2021
• Anticipated Primary Completion Date: Jun 14, 2022
• Anticipated Study Completion Date: Mar 30, 2023

Arms and Interventions

Arm	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)

Outcome Measures

Primary Outcome Measures

1. The treatment-related severe adverse events [7 weeks]

   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 Outcome Measures

1. The weight loss percentage [7 weeks]

   The association between percentage Loss of SMM and weight loss percetage in HNC patients during radiotherapy

2. Scored Patient-Generated Subjective Global Assessment (PG-SGA) [7 weeks]

   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.

3. the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) [7 weeks]

   The association between Loss of SMM and Quality Of Life in HNC patients during radiotherapy

4. the European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Cancer Module (EORTC QLQ-H&N35) [7 weeks]

   The association between Loss of SMM and Quality Of Life in HNC patients during radiotherapy

5. Duration ofParenteral nutrition [7 weeks]

   The association between Loss of SMM and duration of parenteral nutrition in HNC patients during radiotherapy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	YI PAN	Guangzhou	Guangdong	China	510080

Sponsors and Collaborators

• Guangdong Provincial People's Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: YI PAN, Prof., Guangdong Provincial People's Hospital
• ClinicalTrials.gov Identifier: NCT05126095
• Other Study ID Numbers: KY-Q-2021-213
• First Posted: Nov 18, 2021
• Last Update Posted: Dec 2, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by YI PAN, Prof., Guangdong Provincial People's Hospital: Cone-beam Computerized tomography; Skeletal Muscle Mass; Body weight; Malnutrition
• Additional relevant MeSH terms: Head and Neck Neoplasms

Study Results

No Results Posted as of Dec 2, 2021