An observational study in Head and Neck Cancer and Radiotherapy; Adverse Effect, sponsored by Guangdong Provincial People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-02.
Sponsored by Guangdong Provincial People's Hospital · Observational
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.
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.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's planned enrollment of 135 is above the median of 100 across 441 observational studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Guangdong Provincial People's Hospital is the lead sponsor of 231 studies on the registry; 101 are open to participants now.
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Patients with locally advanced HNC scheduled to receive radical radiotherapy
Exclusion Criteria:
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)
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.
Time frame: 7 weeks
The weight loss percentage
The association between percentage Loss of SMM and weight loss percetage in HNC patients during radiotherapy
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 7 weeks
Duration ofParenteral nutrition
The association between Loss of SMM and duration of parenteral nutrition in HNC patients during radiotherapy
Time frame: 7 weeks
This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Guangdong Provincial People's Hospital