Using radiation to treat cancer-related pain by targeting the pituitary gland
Hypophysectomy by Stereotactic Radiosurgery for Cancer-Related Pain
This study is testing if using targeted radiation on the pituitary gland can help relieve severe cancer-related pain for patients who haven't found relief with regular treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06287515 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the feasibility of using stereotactic radiosurgery (SRS) for hypophysectomy to alleviate refractory cancer-related pain in patients at MD Anderson Cancer Center. The primary objective is to enroll and treat a lead-in cohort of 20 patients within one year, assessing their pain levels and quality of life before and after the intervention. Secondary objectives include measuring changes in opioid usage, mood, and self-efficacy related to pain management over time. The study will provide valuable insights into the effectiveness of this novel approach for patients who have not responded to conventional pain management strategies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with poorly controlled cancer-related pain who have exhausted standard pain management options.
Not a fit: Patients with well-controlled pain or those who are not candidates for hypophysectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve pain management and quality of life for patients suffering from refractory cancer-related pain.
How similar studies have performed: While the specific approach of SRS hypophysectomy is novel, similar studies using stereotactic radiosurgery for pain management have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years old on the day of signing informed consent and willing and able to sign a written informed consent. * English fluency in order to complete PROs and neurocognitive assessment * Pathologic or cytologic confirmation of malignancy. * Poorly controlled intractable nociceptive or mixed pain limiting function or quality of life. Participants must have exhausted or not a candidate for standard of care pain control measures such as opioids, injections/ablations, conventional radiation therapy, or surgical intervention with a curative intent and pain limiting function that affects the participants quality of life in the judgment of the treating physician. Refractory status will require at least consultation and two follow-up visits with pain specialists (pain management or supportive care). * ECOG performance status of 0-3. * Life expectancy is greater than 4 weeks and less than 1 year in the treating physician's judgment. Exclusion Criteria: * Participants with prior cranial or head/neck radiation where cumulative organ-at-risk dose constraints cannot be achieved (see section 4.2). * Inability to have an MRI of the brain for reasons such as a non-compatible bioimplant that could be displaced during MRI, shrapnel embedded (such as from war wounds), metal workers, and machinists (potential for metallic fragments in or near the eyes). * Expressions of pain due to depression, delirium or addictive behavior * Participants who are pregnant. * Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study in the judgment of the Investigators.
Where this trial is running
Houston, Texas
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Chenyang Wang, MD — M.D. Anderson Cancer Center
- Study coordinator: Chenyang Wang, MD
- Email: cwang23@mdanderson.org
- Phone: (832) 710-1570
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.