RAD ONC FREEDOM Oncology Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiosurgery.
- Who it may be relevant to
- Registry conditions: Cancer Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Functional Radiosurgery for Easing or Eliminating Debilitating Oncologic Morbidity (FREEDOM)
Overview
The investigators propose to conduct a study in medically refractory cancer pain patients utilizing radiosurgery to ablate the pituitary hypophysis, as well as neuromodulate the centromedian and parafascicular complexes within the thalami - the so-called triple target. This involves treating the pituitary hypophysis and thalamus to a dose of 90 Gy. These patients will have previously failed to achieve adequate pain control with opioid pain regimens and interventional approaches. The trial will involve a multidisciplinary approach involving radiation oncology, neurosurgery, palliative care, and medical oncology colleagues across UCLA.
Detailed description
Refractory pain is one of the most debilitating challenges in oncology patients, particularly at the end of life. Over 60% of cancer patients experience pain, with 30% of these patients becoming refractory to opioid pain medication. Interventional techniques such as nerve blocks and pain pumps only transiently relieve pain and are often not viable for advanced cancer patients. In patients with diffuse metastatic disease with less than 3-6 months survival, there is a pressing need for a rapid and thorough relief of pain sensation.
Recently, using highly focused radiation delivered to very unique targets in the brain, patients can have marked reduction in perceived pain. There are centers in the brain dubbed as gateways of pain, including the pituitary hypophysis1 and the centromedian and parafascicular complexes2, with some preliminary data also involving the anterior cingulum. Ablation or neuromodulation of these targets with focused high doses of radiation have been shown in small series to provide pain relief in \~3.5 days with a 50% reduction of perceived pain.
The investigators propose to conduct a study in medically refractory cancer pain patients utilizing radiosurgery to ablate the pituitary hypophysis, as well as neuromodulate the centromedian and parafascicular complexes within the thalami - the so-called “triple target.†3 This involves treating the pituitary hypophysis and thalamus to a dose of 90 Gy. These patients will have previously failed to achieve adequate pain control with opioid pain regimens and interventional approaches. This trial will involve a multidisciplinary approach involving radiation oncology, neurosurgery, palliative care, and medical oncology colleagues across UCLA.
Interventions
- Radiation Radiosurgery
intracranial functional stereotactic radiosurgery (FnSRS) to the triple target: centromedian-parafasciular complex bilaterally, and the hypophysis
Primary outcome measures
- Pain Inventory [Time frame: - Baseline: Daily measurements on three separate days prior to treatment (Day -7 +/- 3 days, Day -3 +/- 1 day, Day -2 +/- 1 day)- Post-baseline: Days +1, 2, 3, 4, 7, 14, 21, 28]
Secondary outcome measures (9)
- Opioid Usage Quantification [Time frame: o Pre-study (screening visit) and Baseline (Day-7, Day-3, & Day-2)o Days +1, 2, 3, 4, 7, 14, 21, 28]
- functional stereotactic radiosurgery (FnSRS) treatment side effects [Time frame: 28 days post treatment]
- Pain anxiety symptom scale (PASS-20) [Time frame: Baseline visit (Day -7) Day +28 after treatment.]
- 17-item Hamilton Depression Rating Scale: [Time frame: Baseline visit (Day -7) Day +28 after treatment.]
- Hamilton Anxiety Rating Scale [Time frame: Baseline visit (Day -7) Day +28 after treatment.]
- Pittsburgh Sleep Quality Index [Time frame: Baseline visit (Day -7) Day +28 after treatment.]
- Social disability screening schedule/WHO disability assessment schedule [Time frame: Baseline visit (Day -7) Day +28 after treatment.]
- Activity of Daily Living Scale [Time frame: Baseline visit (Day -7) Day +28 after treatment.]
- 36-item Short Form-Health Survey/RAND-36 [Time frame: Baseline visit (Day -7) Day +28 after treatment.]
Eligibility criteria
Inclusion criteria
- Male or female ≥ 18 years of age on day of SRS treatment.
- Documentation of insufficiently controlled mixed, complex cancer pain based on Brief Pain Inventory (BPI) >8/10 despite optimization of opioid regimen
- Not eligible for or willing to undergo further pain-relieving interventions
- Written informed consent (and assent when applicable) obtained from patient or patient's legal representative and ability for patient to comply with the study requirements and agree to undergo the study's SRS treatment plan.
Exclusion criteria
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Claustrophobia or inability to life flat
- Inability to undergo routine imaging studies
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Current history of intracranial malignancy or brain metastasis
- Any prior intracranial irradiation
- Previous history of craniotomy, deep brain stimulation (DBS) or laser interstitial themal therapy (LITT).
- Presence of intracranial hardware such as leads for DBS or any other material that may interfere with safe treatment.
- Any comorbidity or condition which would limit full compliance with the protocol
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- UCLA / Jonsson Comprehensive Cancer Center — Los Angeles
Identifiers
NCT: NCT07605546 · 25-0116