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TOPICal Steroid versus placebo for the prevention of radiation dermatitis in head and neck cancer patients receiving chemoradiotherapy : a phase III, randomized, double-blinded trial

TOPICal Steroid versus placebo for the prevention of radiation dermatitis in head and neck cancer patients receiving chemoradiotherapy : a phase III, randomized, double-blinded trial - TOPICS study(J-SUPPORT 1602)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000027161
Enrollment
220
Registered
2017-05-01
Start date
2017-05-07
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

Locally Advanced Squamous Cell Carcinoma of the Head and Heck

Interventions

Basic nursing care with Topical steroid Start:develop to Grade 1 radiation dermatitis or recieced 30Gy of RT Finish:Improved to Grade 1 radiation dermatitis or 8 weeks after start of this treatmen

Sponsors

Department of Radiation Oncology, National Cancer Center Hospital East
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: *PS 0-1 *Have a plan to receive CRT,CDDP/RT *Have a plan to receive >66Gy radiotherapy *Have a plan to receive >200mg/m2 CDDP during RT *No diseases related with dermatitis *Written in informed consent

Exclusion criteria

Exclusion criteria: Received steroid therapy before this treatment Have an infection Have allergies to Vaseline or topical steroid Have severe complications

Design outcomes

Primary

MeasureTime frame
The frequency of radiation dermatitis grade2

Secondary

MeasureTime frame
The frequency of radiation dermatitis grade2 Treatment comliance The frequency of local infection The duration of grade2/3/4 radiation dermatitis the rate of radiation dermatitis grade 2 at 2weeks after the end of radiotherapy Toxicties(including PRO-CTCAE)

Countries

Japan

Contacts

Public ContactSadamoto Zenda

National Cancer Center Hospital East Department of Radiation Oncology

szenda@east.ncc.go.jp04-7133-1111

Outcome results

None listed

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