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The effects of active nutritional support to patients with head and neck cancer during concurrent chemoradiotherapy

The effects of active nutritional support to patients with head and neck cancer during concurrent chemoradiotherapy - The effects of active nutritional support to patients with head and neck cancer during concurrent chemoradiotherapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004738
Enrollment
70
Registered
2010-12-16
Start date
2011-01-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

head and neck cancer(nasopharyngeal carcinoma, oropharyngeal carcinoma, hypopharyngeal carcinoma, supraglottic laryngeal carcinoma, cancers of the oral cavity)

Interventions

For the interventional group, daily nutritional energy will be calculated by multiplying the BEE by the activity factor (1.2) and the stress factor (1.5). The calculated energy will be administered b
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) will be supplied in the case of insufficient intake. For the control group, daily nutritional energy will be calculated by multiplying the BEE by the activity factor (1.2) and the stress factor (1.1

Sponsors

Osaka Medical Center for Cancer and Cardiovascular Diseases
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)patients with head and neck cancer (nasopharyngeal carcinoma, oropharyngeal carcinoma, hypopharyngeal carcinoma, oral cavity carcinoma, supraglottic carcinoma) 2)clinical stage: II, III, IVA, IVB 3)PS=0, 1, 2 4)Leukocyte count>3,000/mm3 5)Platelet count>10x104/mm3 6)Hemoglobin>10g/dL 7)AST(GOT)<2.0 times the upper limit of normal at hospital 8)ALT(GPT)<2.0 times the upper limit of normal at hospital 9)Total bilirubin<3.0mg/dL 10)Creatinine<1.3mg/dL 11)Patients whose prognosis will be over 3 months 12)Patients who fully understand the study procedures and have given voluntary written informed consent after a full explanation is given

Exclusion criteria

Exclusion criteria: 1)Patients with ileus 2)Patients with no residual intestinal function 3)Patients with severe liver disorder or renal disorder 4)Patients with abnormal glucose metabolism such as severe diabetes mellitus : HbA1c > 7.0% 5)Patients with congenital disorders of amino acid metabolism 6)Patients with allergy to any ingredient of milk 7)Patients with electrolyte metabolism 8)Patients with hemophilia 9)Patients who were given a blood transfusion within 1 month 10)Pregnant women, women suspected of being pregnant, or lactating women

Design outcomes

Primary

MeasureTime frame
Percent change of body weight loss during chemoradiotherapy

Secondary

MeasureTime frame
1)Physical examination, blood test 2)immune status index 3)treatment completion rate 4)occurrence of adverse events

Countries

Japan

Contacts

Public ContactHirokazu Uemura, Susumu Nakahara

Osaka Medical Center for Cancer and Cardiovascular Diseases Department of Otolaryngology, Head and Neck Surgery

06-6972-1181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026