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Search / Trial NCT06903585

Non Steroidal Anti-inflammatory Drugs in the Prevention of Bone Pain Flares After Palliative Radiotherapy

Launched by AMERICAN UNIVERSITY OF BEIRUT MEDICAL CENTER · Mar 25, 2025

Trial Information

Current as of July 27, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying whether a type of medication called Non-Steroidal Anti-inflammatory Drugs (NSAIDs), specifically Proxen, can help prevent painful bone flares that some patients experience after receiving palliative radiotherapy for cancer. Palliative radiotherapy is a treatment used to relieve pain caused by cancer that has spread to the bones, but unfortunately, about 40% of patients may feel an increase in pain, known as a bone pain flare, within the first 10 days after treatment. This trial aims to see if taking NSAIDs can help reduce this pain flare and improve the quality of life for patients.

To be eligible for this trial, participants must be at least 18 years old and have a solid tumor that has spread to the bones, causing pain. They should also have a minimum pain score of 2 on a scale of 0 to 10. However, individuals with certain conditions, such as blood cancers or those currently using steroids or other specific medications that can’t be stopped, will not be able to participate. If you join the trial, you will be randomly assigned to receive either the NSAID or a placebo (a dummy pill) without knowing which one you received, and researchers will monitor your pain and overall well-being throughout the study.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age 18 years or older
  • Primary Solid tumor (Any type of solid tumor)
  • Painful bone metastases which are otherwise uncomplicated (no fracture and no neurologic symptoms due to nerve impingement or compression)
  • Baseline pain score on a numeric rating scale (0-10) of at least 2
  • Stable dose and schedule of narcotic medications prescribed
  • Exclusion Criteria:
  • Hematologic malignancy
  • Previously irradiated bone
  • Current use of steroids
  • Current use of NSAIDs which cannot be stopped before randomization
  • Contraindications for NSAIDs (hypersensitivity, PUD, prior GI bleed, CKD, HTN, HF, AERD/asthma)
  • Contraindications for PPIs

About American University Of Beirut Medical Center

The American University of Beirut Medical Center (AUBMC) is a leading academic medical institution in the Middle East, dedicated to advancing healthcare through innovative research, education, and clinical excellence. As a prominent sponsor of clinical trials, AUBMC integrates cutting-edge scientific inquiry with patient-centered care to enhance therapeutic options and improve health outcomes. With a commitment to ethical standards and regulatory compliance, AUBMC collaborates with multidisciplinary teams to conduct rigorous trials that contribute to the global medical knowledge base and address critical health challenges in the region and beyond.

Locations

Beirut, , Lebanon

Patients applied

0 patients applied

Trial Officials

Lara Hilal, MD

Principal Investigator

AUBMC

Bassem Youssef, MD

Principal Investigator

AUBMC

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported