Pilot study about nutritional effect of elemental diet supplementation during chemoradiotherapy for head and neck cancer.

Pilot study about nutritional effect of elemental diet supplementation during chemoradiotherapy for head and neck cancer. - Pilot study of nutritional effect of elemental diet by the difference in regimen of chemoradiotherapy for head and neck cancer.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012740

Enrollment

Registered

2014-01-01

Start date

2012-02-09

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

Interventions

Elemental diet (300kcal/day) administration for at least 2 weeks from start of chemotherapy containing 5-FU Elemental diet (300kcal/day) administration for at least 2 weeks from start of chemotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with head and neck cancer who will undergo chemotherapy. 2.Patient age at the time of obtaining informed consent is 20 years of age or older. 3.Written informed consent.

Exclusion criteria

Exclusion criteria: 1.Past history of serious drug hypersensitivity. 2.Severe diabetes or possibility of glucose metabolism abnormality due to high-dose steroid treatment. 3.Abnormality in amino acid metabolism. 4.Pregnant or nursing women and those with the possibility of pregnancy. 5.Participation judged by physician to be inadvisable.

Design outcomes

Primary

Measure	Time frame
Change of nutritional status during chemoradiotherapy, serum albumin, rapid turnover protein and CRP	—

Secondary

Measure	Time frame
1)Physical examination, blood biochemistries 2)Adverse events	—

Countries

Japan

Contacts

Public ContactKiyoaki Tsukahara

Tokyo Medical University Hachioji Medical Center Otorhinoryngology, Head and Neck surgery

tsuka@tokyo-med.ac.jp042-665-5611

Outcome results

None listed

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