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Clinical research on effectiveness of amino acids supplementation on the severity of mucositis during chemoradiotherapy in oral cancer patients.

Clinical research on effectiveness of amino acids supplementation on the severity of mucositis during chemoradiotherapy in oral cancer patients. - Clinical research on effectiveness of amino acids supplementation on the severity of mucositis during chemoradiotherapy in oral cancer patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000022709
Enrollment
52
Registered
2016-06-13
Start date
2016-06-30
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

Oral cancer

Interventions

Test foods containing of amino acids is administered by orally or gavage, twice daily (morning and evening) from the start day of the chemotherapy to 14 days after the chemoradiotherapy. Placebo is

Sponsors

KYOWA HAKKO BIO CO., LTD
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients (men and women aged from 20 to 90 years old) undergo chemoradiotherapy as preoperative treatment 2) Patients from whom written informed consent is obtained 3) Patients deemed suitable by the principal investigator, investigators of the research project or investigators of the sub institution.

Exclusion criteria

Exclusion criteria: 1) Patients who have the severe complications 2) Patients who have the history of severe hypersensitivity 3) Patients who have the history of aminoacidopathy 4) Patients included in other clinical studies within 3 months or in process. 5) Patients with other conditions whom principal investigator, the investigator of this project and the investigator of sub institution consider inadequate such as routine users of similar food (e.g. amino acid supplement) 6) Patients who have renal dysfunction that creatinine clearance are less than 30 ml/min

Design outcomes

Primary

MeasureTime frame
The severity of mucositis

Countries

Japan

Contacts

Public ContactKazunari Oobu

Kyushu University Hospital Department of Oral Surgery

kazunari@dent.kyushu-u.ac.jp092-642-6447

Outcome results

None listed

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