Efficacy and safety of HMB/Gln/Arg for the prophylaxis of chemoradiation -induced mucositis in head and neck squamous cell carcinoma: Randomized Phase II Clinical Study

Efficacy and safety of HMB/Gln/Arg for the prophylaxis of chemoradiation -induced mucositis in head and neck squamous cell carcinoma: Randomized Phase II Clinical Study - Efficacy and safety of HMB/Gln/Arg for the prophylaxis of chemoradiation -induced mucositis in head and neck squamous cell carcinoma: Randomized Phase II Clinical Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000050011

Enrollment

Registered

2023-01-11

Start date

2018-03-01

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 squamous cell carcinoma

Interventions

Administe HMB/Arg/Gln to patients who undergo cis-platinum CRT patients who undergo cis-platinum CRT.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria were historically diagnosed HNSCC arising in nasopharynx, oropharynx, hypopharynx or larynx; age of 20-75years; an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; subject to more than 60Gy of platinum based CRT; and normal findings in pretreatment swallowing videofluorography.

Exclusion criteria

Exclusion criteria: Exclusion criteria were T4 larynx or hypopharynx; T1-2 glottic larynx; and previous history of irradiation in the head and neck.

Design outcomes

Primary

Measure	Time frame
Incidence of more than grade 3 mucositis	—

Countries

Japan

Contacts

Public ContactMuneyuki Masuda

National Hospital Organization Kyushu Cancer Center Head and Neck Surgery

mmuneyuki@icloud.com092-541-3231

Outcome results

None listed

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