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

NCT ID: NCT05126095

Last Updated: 2021-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

135 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-03

Study Completion Date

2023-03-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Head and Neck Cancer Radiotherapy; Adverse Effect

Keywords

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Cone-beam Computerized tomography Skeletal Muscle Mass Body weight Malnutrition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Radical radiotherapy

Intervention Type RADIATION

Intensity-modulated radiation therapy (IMRT)

Interventions

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Radical radiotherapy

Intensity-modulated radiation therapy (IMRT)

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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YI PAN

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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YI PAN, Prof.

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial People's Hospital

Locations

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YI PAN

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yi Pan, Prof.

Role: CONTACT

Phone: +862083827812

Email: [email protected]

Facility Contacts

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YI PAN

Role: primary

Other Identifiers

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KY-Q-2021-213

Identifier Type: -

Identifier Source: org_study_id