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Radiosurgery for Severe Refractory Cancer Pain: A Sham-Controlled Pilot Trial
Sponsor: Centro Internacional del Cáncer
Summary
This pilot randomized trial assessed whether a sham-controlled comparison of triple-target stereotactic radiosurgery is feasible in adults with advanced (stage IV) cancer and severe mixed pain refractory to optimized pharmacologic and specialist management. Participants were randomized 1:1 to single-session Gamma Knife radiosurgery delivered to the hypophysis and both medial thalami, or to an identical sham procedure without radiation; both arms continued standard pain care. The main comparison was the change in pain intensity on a 0-10 visual analog scale from baseline to day 15. Opioid consumption, quality of life, and safety were explored. Enrollment was stopped after 10 of a planned 20 participants following an ethical reassessment by the investigators.
Official title: Triple-Target Stereotactic Radiosurgery for Refractory Mixed Cancer Pain: A Sham-Controlled Pilot Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2024-04-01
Completion Date
2025-06-01
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
Triple-target stereotactic radiosurgery
Single-session Gamma Knife radiosurgery to the hypophysis and bilateral medial thalamus, 45 Gy prescribed at the 50% isodose line (maximum 90 Gy), plus standard pain care.
Sham radiosurgery
Identical preoperative evaluation, imaging, sedation, stereotactic frame placement and \~40-minute waiting period, with no treatment plan and no radiation delivered, plus standard pain care.
Locations (1)
Centro Internacional de Cáncer
San Salvador, San Salvador Department, El Salvador