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The single-armed confirmatory trial for immediate effectivity and safety of palliative arterial embolization for painful bone metastases. (JIVROSG/J-SUPPORT 1903)

The single-armed confirmatory trial for immediate effectivity and safety of palliative arterial embolization for painful bone metastases. (JIVROSG/J-SUPPORT 1903) - PALEM trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000040794
Enrollment
120
Registered
2020-07-01
Start date
2021-03-01
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

bone metastases

Interventions

Arterial embolization with a spherical embolic material is performed for painful bone metastases.

Sponsors

Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Lead Sponsor
Japan Supportive, Palliative and Psychosocial Oncology Group(J-SUPPORT)
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Diagnosed as painful bone metastases 2)Strongest pain site matches the bone metastasis site 3)No spinal cord compression in the bone metastasis site 4)The patient has pain described over 5 in Numerical Rating Scale. 5)Patient has received some form of analgesic medication for pain relief. 6)Radiation therapy (RT) has not been performed on the site of arterial embolization within 2 months. 7)The patuient has not been started new chemotherapy or 8)Originated cancer is not limited. 9)promising over 1 month alive after treatment 10)eGFR is over 30 ml/min/1.73m2 11)PT-INR is over 1.5 and Platelet count is over 50000/dl. 12)over 20 years old 13)Signed a consent form

Exclusion criteria

Exclusion criteria: 1)Difficult to hold rest position 2)The patient could not describe pain by Numeric Rating Scale. 3)Preexisting disorders of being allergic to iodinated contrast material 4)Cannot stop anticoagulants and antithrombotic drugs. 5)Qualified ineligible patients being this clinical trial by responsible doctor

Design outcomes

Primary

MeasureTime frame
1) pain relief at 72 hours after arterial embolization(TAE) 2) adverse events related to TAE 2 weeks after TAE

Countries

Japan

Contacts

Public ContactYasunori Arai

National Cancer Center Hospital East Department of Diagnostic Radiology

yarai1976@gmail.com04-7133-1111

Outcome results

None listed

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