High-dose radiation therapy for pain relief in bone metastases

A Pilot Study of Stereotactic Radiosurgical Hypophysectomy for Intractable Pain From Bone Metastases

This study is testing if a single high dose of radiation therapy can help relieve severe pain for people with bone metastases.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (other)
• Drugs / interventions: radiation
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT03377517 on ClinicalTrials.gov

What this trial studies

This research aims to evaluate the effectiveness of delivering a single high dose of radiation therapy to the pituitary gland and stalk to alleviate severe pain caused by bone metastases. Although not yet standard practice, preliminary evidence suggests that radiosurgical hypophysectomy may safely reduce cancer-related pain. This pilot study seeks to provide well-designed prospective data on its safety and efficacy, which could pave the way for larger follow-up trials if successful. Participants will be closely monitored to assess pain relief and overall quality of life improvements.

Who should consider this trial

Good fit: Ideal candidates include adults with confirmed malignancy and uncontrolled pain from bone metastases despite standard treatments.

Not a fit: Patients who do not have intractable pain or those who are not suitable for radiation therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide significant pain relief for patients suffering from intractable pain due to bone metastases.

How similar studies have performed: While this approach is not widely practiced, preliminary small series have shown promise, indicating potential efficacy, but well-designed studies are lacking.

Eligibility criteria

Inclusion Criteria:

1. Cytologic proof of malignancy
2. Radiographic evidence of bone metastases
3. Intractable pain uncontrolled by opioids, medical management, injections/ablation or surgical intervention that would be difficult to address with conventional radiation therapy or other standard options and is limiting the patient's function and quality of life. Intractable pain will be defined as a visual analogue score of at least 4.
4. Definitive radiographic progression of osseous and/or visceral metastases on standard staging scans (CT, MRI, bone scan, PET scan or any other standard of care imaging) performed within the last 3 months in spite of standard oncologic interventions and/or inability to tolerate standard oncologic interventions
5. Life expectancy at least 4 weeks
6. Age≥ 18 years
7. Patients of childbearing potential (male or female) must practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child
8. Patient must have the ability to understand and the willingness to sign a written informed consent document
9. All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria:

1. Prior brain radiation
2. Patients must not have a serious medical or psychiatric illness that would, in the opinion of the treating physician prevent informed consent or completion of protocol treatment
3. Isolated localized pain amenable to focal radiation therapy, or pain well controlled by opioids, medical management, injections/ablation or surgical intervention
4. Malignancies being managed with curative intent
5. Life expectancy \<4 weeks
6. The tumor amenable to curative management

Where this trial is running

Baltimore, Maryland

• The Sidney Kimmel Comprehsensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States (RECRUITING)

Study contacts

• Principal investigator: Kristin Redmond, MD — Johns Hopkins University
• Study coordinator: Kristin Redmond, MD

Conditions: Bone Metastases