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CryOtherapy tO prevent OraL mucositis in Patients with Breast Cancer Receiving Dato-DXd: A Pilot Study

COOL study - COOL study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000058003
Enrollment
30
Registered
2025-06-16
Start date
2025-07-01
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

Breast cancer

Interventions

The cryotherapy in this study will be performed according to the following procedure: 1. Begin oral cooling by placing ice chips or ice pops in the mouth starting 5 minutes before the administration

Sponsors

Toranomon hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The patient has been histologically diagnosed with invasive breast cancer. 2. The patient has been diagnosed with metastatic or recurrent breast cancer. 3. The patient is 18 years of age or older at the time of consent. 4. The patient has a performance status (PS) of 0 or 1. 5. The patient is scheduled to receive Dato-DXd treatment. 6. Written informed consent for participation in the study has been obtained.

Exclusion criteria

Exclusion criteria: 1. The patient has oral mucositis prior to study enrollment. 2. The patient is pregnant or breastfeeding. 3. The patient has an active infection requiring treatment.

Design outcomes

Primary

MeasureTime frame
Incidence of oral mucositis by Day 56 from treatment initiation.

Countries

Japan

Contacts

Public ContactTAKESHI YAMAGUCHI

Toranomon hospital Department of medical oncology

takyamag@toranomon.gr.jp03-3588-1111

Outcome results

None listed

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