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

  • STATUS
    Recruiting
  • participants needed
    135
  • sponsor
    Guangdong Provincial People's Hospital
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Updated on 29 November 2021
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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.

Details
Condition Head and Neck Cancer, Radiotherapy; Adverse Effect
Age 18years or above
Treatment Radical radiotherapy
Clinical Study IdentifierNCT05126095
SponsorGuangdong Provincial People's Hospital
Last Modified on29 November 2021

Eligibility

 Yes No Not Sure

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
Clear my responses
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