Clinical trial NCT06903585: Non Steroidal Anti-inflammatory Drugs in the Prevention of Bone Pain Flares After Palliative Radiotherapy
Official title: Non-steroidal Anti-inflammatory Drugs in the Prevention of Bone Pain Flares After Palliative Radiotherapy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Bone Pain Flare
Bone Metastasis
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2025-03-31
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Solid tumors have the tendency to spread to other organs in around 26% of cases, with many cases involving the bone causing severe bone destruction and pain that reduces patients' quality of life. Palliative radiation therapy is used as a standard of care to decrease cancer-related bone pain, as it has been proven to provide pain relief in many patients, either partially or totally, within only a few weeks. However, some patients experience worsening of bone pain especially within the first 10 days after radiation therapy, this is called bone pain flare, and its incidence is estimated to be around 40%. This pain flare tends to further reduce these patients' quality of life considering their main illness, which necessitates its prevention or alleviation.

Non-Steroidal Anti-inflammatory Drugs (NSAIDs) which are a key component of the World Health Organization (WHO) analgesic options used to alleviate cancer pain have not had a good share of published trials in the prevention of bone pain flares.

In this light the investigators aim to conduct a double-blinded, placebo-controlled randomized controlled trial to investigate the effectiveness of NSAIDs, specifically Proxen, in preventing bone pain flares after palliative radiotherapy, and as a secondary endpoint they will compare the quality of life and side effects experienced by patients in either group.


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

Primary outcomes:
measure: Occurrence of a pain flare within the first 10 days after palliative radiation therapy
timeFrame: From enrollment till 10 days after the start of palliative radiotherapy
Secondary outcomes:
measure: Change in quality of life from start of palliative radiotherapy till one month after
timeFrame: From enrollment till 30 days after the start of palliative radiotherapy
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
Study officials:
affiliation: AUBMC
name: Lara Hilal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AUBMC
name: Bassem Youssef, MD
role: PRINCIPAL_INVESTIGATOR
References: