Comparison trial to examine usefulness and safety of nutritional agents with differing fatty acid compositions in head and neck cancer surgery patients with free flaps reconstruction

Comparison trial to examine usefulness and safety of nutritional agents with differing fatty acid compositions in head and neck cancer surgery patients with free flaps reconstruction - examine usefulness and safety of nutritional agents with differing fatty acid compositions in head and neck cancer surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013158

Enrollment

Registered

2014-02-14

Start date

2010-01-01

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 surgery patients with free flaps reconstruction

Interventions

Oxepa Ensure H

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. At least 20 years of age, of either gender 2. Has undergone head/neck cancer surgery with free flaps reconstruction (excepting jejunum surgery cases, no laparotomy) 3. Possibility of nutritional supplementation via enteral nutrition beginning within 24 h of surgery, for at least 5 days 4. Wish to participate in present trial, written informed consent obtained from subject themselves or family member/relative Patients must fulfill all of criteria 1 to 4 above for participation.

Exclusion criteria

Exclusion criteria: 1. Pregnancy or lactation 2. Less than 20 years of age 3. Very short vital prognosis (expected to live less than 28 days due to uncontrolled cancer or other chronic or incurable terminal diseases) 4. Recent stroke or subarachnoid hemorrhage 5. Non-functioning ileus or intestinal tract 6. Significant immunosuppression (leukocytes<1000 cells/mm3) 7. Infection with human immunodeficiency virus 8. Hyperlipidemia (TG>500, T-cho>300) 9. Unsuitability for enteral nutrition 10.Recent gastrointestinal hemorrhage 11. Poorly controlled diarrhea 12. Congenital metabolism disorder 13. Milk protein intolerance 14. Acute nephritis, nephrosis, end-stage renal disease requiring strict limitation of protein, electrolytes 15. Cardiac failure accompanied by nausea, vomiting, diarrhea 16. Participation in another trial within 30 days prior to registration for present trial 17. Judged unsuitable by principal or sub-investigator for other reasons

Design outcomes

Primary

Measure	Time frame
Change in maximum body temperature; CRP; Procalcitonin	—

Secondary

Measure	Time frame
Days in ICU; Days in hospital	—

Countries

Japan

Contacts

Public ContactTsukahara Kiyoaki

Tokyo Medical University Hachioji Medical Center Otolaryngology, Head and Neck Surgery

tsuka@tokyo-med.ac.jp0426655611

Outcome results

None listed

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