Painful bone metastasis
Conditions
Interventions
HIFU group:HIFU treatment
HIFU treatment:Radiation therapy
Sponsors
Suining Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: ? The pathological diagnosis was confirmed, and the bone lesion biopsy was consistent. It has typical imaging manifestations of bone metastasis. ? The bone metastases were located in the ribs, limbs (including joints), pelvis, shoulder joint and the posterior part of the third lumbar spine (including). The lesions were clearly visible on CT or non-enhanced MR. ? Expected survival time >3 months; ? no radiotherapy or HIFU treatment in the past 2 months; ? The pain site can be identified, the numerical rating scale (NRS) score of the target lesion is =4 points, and the NRS score of the target lesion to be treated is > 2 points than that of other parts; ? the degree of pain is stable, with or without taking analgesics; ? During the study period and within 14 days after the last dose of study drug, no fertility or sperm/egg donation plan and voluntary use of effective physical contraception; ? Before the trial, they have understood the nature, significance, possible benefits, possible inconvenience, potential risks and discomfort of the trial in detail, and voluntarily participate in the clinical trial, can communicate well with the investigators, comply with the requirements of the whole study, and sign the written informed consent.
Exclusion criteria
Exclusion criteria: ? Pain variables >5; New chemotherapy for pain relief initiated within the last 2 weeks; ? The predicted survival time was less than 3 months; ? accompanied by unstable heart disease or active infection and other serious diseases; ?Karnofsky performance status (KPS)<30; ? pregnant or lactating women, or those with a positive pregnancy test; ? Patients are currently participating or have been participating in another study, have received investigational treatment or other new treatment in such a study within 12 weeks before signing the informed consent form, or they do not agree to avoid participating in another study; ? The patient has a new clinical condition, a change in an existing clinical condition, an abnormal laboratory test, or a need for a new treatment or medication that meets one of the exclusion criteria described above or that, in the opinion of the investigator, would pose a risk to the patient if enrolled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NRS(numerical rating scale for pain);OR(overall pain response rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| FPS-R(Wong-Baker faces pain scale-Revised);QLQ-BM22(Cancer Quality of Life Questionnaire-Bone Metastases22); | — |
Countries
China
Contacts
Public ContactWang Zhiqiang
Suining Central Hospital
Outcome results
None listed