Enrollment halted after 10 of 20 planned participants following ethical reassessment by the investigators; continued sham allocation was judged ethically disproportionate.
Triple-Target Stereotactic Radiosurgery for Refractory Mixed Cancer Pain: A Sham-Controlled Pilot Randomized Controlled Trial
Sponsor study identifier
Secondary identifiers
OTHER · National Ethics Committee of El Salvador
interventional
10
1 country
1
Study Start
April 1, 2024
Actual (reported)Primary Completion
June 1, 2025
Actual (reported)Study Completion
June 1, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2025
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1, 2024
Actual (reported)June 1, 2025
Actual (reported)June 1, 2025
Actual (reported)October 7, 2026
Actual (reported)October 13, 2026
Actual (reported)Change in Pain Intensity on a 0-10 Visual Analog Scale (VAS)
Pain measured on a 0-10 VAS (0 = no pain, 10 = worst imaginable pain). Mean change from baseline to day 15, the latest scheduled assessment with complete data in all participants. Negative values indicate pain reduction.
Baseline and 15 days
Change in Daily Opioid Consumption (Morphine Milligram Equivalents)
Baseline up to 12 months
Number of Participants With Serious Adverse Events, Adverse Radiation Effects, or Hypopituitarism
Up to 12 months
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.
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.
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.
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.
Centro Internacional de Cáncer
San Salvador, San Salvador Department, El Salvador
Lovo EE, Moreira A, Cruz C, Carvajal G, Barahona KC, Caceros V, Blanco A, Mejias R, Alho E, Soto T. Radiomodulation in Mixed, Complex Cancer Pain by Triple Target Irradiation in the Brain: A Preliminary Experience. Cureus. 2022 May 28;14(5):e25430. doi: 10.7759/cureus.25430. eCollection 2022 May.
Lovo EE, Campos FJ, Caceros VE, Minervini M, Cruz CB, Arias JC, Reyes WA. Automated Stereotactic Gamma Ray Radiosurgery to the Pituitary Gland in Terminally Ill Cancer Patients with Opioid Refractory Pain. Cureus. 2019 Jun 3;11(6):e4811. doi: 10.7759/cureus.4811.
10 participants (actual enrollment reported by the registry).
First Submitted
October 7, 2026
First Posted
October 13, 2026
Study Start
April 1, 2024
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 1, 2025
Actual (reported)Study Completion
June 1, 2025
Actual (reported)Last Updated
October 13, 2026
Record last verified: 2026-10
De-identified participant-level data, the data dictionary, the study protocol, and the analysis code are available from the corresponding author on reasonable request.
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Source: ClinicalTrials.gov.
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