An interventional study of nutrition management in Head and Neck Cancer, Nutrition Related Cancer and Radiation-Induced Mucositis, sponsored by Jing Yan. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-02-10.
Sponsored by Jing Yan · Not applicable, Interventional, and Supportive care
The goal of this clinical trial is to learn about the effect of nutritional management on radiation-induced oral mucositis in patients with advanced head and neck cancer during the peri-radiotherapy period . The main questions it aims to answer are:
Participants will be treated according to the NCCN guidelines. In addition, clinical pharmacists and registered dietitians provided nutritional intervention strategies based on clinical and nutritional assessments for the patients in the peri-radiotherapy nutrition group.
Researchers will compare clinical routine examination and nutritional indicators between the standard treatment group and the peri-radiotherapy nutrition management group to see if nutrition management effects.
2,403 studies on the registry are indexed under Head and Neck Neoplasms; 559 are open to participants now.
This study's planned enrollment of 60 is above the median of 47 across 1,791 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →This is the only study on the registry with Jing Yan as lead sponsor.
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Exclusion Criteria:
Nutritional management was performed by clinical pharmacists and registered dietitians to develop nutritional intervention strategies based on patient clinical assessment and nutritional assessment. PG-SGA score was 0-3 points, and diet guidance was given. PG-SGA score \> 4 points, artificial nutrition intervention was carried out, and the way and amount of nutritional intervention were clarified to achieve the final daily energy and protein target requirements. Nutritional interventions and assessments were adjusted over time.
Behavioral: nutrition management
Nutritional management was performed by clinical pharmacists and registered dietitians to develop nutritional intervention strategies based on patient clinical assessment and nutritional assessment. PG-SGA score was 0-3 points, and diet guidance was given. PG-SGA score \> 4 points, artificial nutrition intervention was carried out, and the way and amount of nutritional intervention were clarified to achieve the final daily energy and protein target requirements. Nutritional interventions and assessments were adjusted over time.
Degree of radiation-induced oral mucositis (RTOG criteria)
The Radiation Oncology Group (RTOG) grade of acute radiation injury was used for evaluation, which was divided into 0 to Ⅳ grades. The mild grade included 0, Ⅰ, and Ⅱgrades (grade 0 was no mucosal response; GradeⅠ: erythema, mild pain; GradeⅡ: spotty mucositis with serous exudation), severe grade Ⅲ- IV (Ⅲ: patchy fibrous mucositis with severe pain; Grade IV: necrosis, ulcer, hemorrhage).
Time frame: six months
No study locations are listed for this record.
Start is estimated for Mar 2023; primary completion for Dec 2025, 33 months later.
Of 412 non-industry interventional studies with no phase under Head and Neck Neoplasms, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 67. This study's planned 33 months is close to that.
Counting every sponsor, half of 427 studies reached it within 34 months; a quarter within 18 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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