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

November 21, 2021 updated by: YI PAN, Guangdong Provincial People's Hospital

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 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.
7 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The weight loss percentage
Time Frame: 7 weeks
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)
Time Frame: 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.
7 weeks
the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time Frame: 7 weeks
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)
Time Frame: 7 weeks
The association between Loss of SMM and Quality Of Life in HNC patients during radiotherapy
7 weeks
Duration ofParenteral nutrition
Time Frame: 7 weeks
The association between Loss of SMM and duration of parenteral nutrition in HNC patients during radiotherapy
7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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