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

NCT ID: NCT06903585

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 385 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2029-04-30

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.

Conditions

Bone Pain Flare; Bone Metastasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

NSAID arm

People in this arm will receive the NSAID naproxen for 5 days, starting from the day they first receive palliative radiotherapy, they will take it as an initial dose of 500mg then as 250mg every 8 hours for a total of 5 days.

Group Type: ACTIVE_COMPARATOR

Naproxen (Proxen S)

Intervention Type: DRUG

Naproxen will be given for 5 days starting from the day subjects first receive palliative radiotherapy, it will be taken as an initial dose of 500mg then as 250mg every 8 hours for a total of 5 days.

Esomeprazole 20mg once daily

Intervention Type: DRUG

Esomeprazole will be given to all subjects as 20mg once daily starting from the day they start palliative radiotherapy and for a total of 5 days.

Placebo arm

People in this arm will receive placebo pills for 5 days, starting from the day they first receive palliative radiotherapy, they will take a placebo pill every 8 hours for a total of 5 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be given for 5 days starting from the day subjects first receive palliative radiotherapy, it will be given every 8 hours for a total of 5 days.

Esomeprazole 20mg once daily

Intervention Type: DRUG

Esomeprazole will be given to all subjects as 20mg once daily starting from the day they start palliative radiotherapy and for a total of 5 days.

Interventions

Naproxen (Proxen S)

Naproxen will be given for 5 days starting from the day subjects first receive palliative radiotherapy, it will be taken as an initial dose of 500mg then as 250mg every 8 hours for a total of 5 days.

Intervention Type: DRUG

Placebo

Placebo will be given for 5 days starting from the day subjects first receive palliative radiotherapy, it will be given every 8 hours for a total of 5 days.

Intervention Type: DRUG

Esomeprazole 20mg once daily

Esomeprazole will be given to all subjects as 20mg once daily starting from the day they start palliative radiotherapy and for a total of 5 days.

Intervention Type: DRUG

Other Intervention Names

NSAIDs; PPI; Nexium

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American University of Beirut Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Lara Hilal

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lara Hilal, MD

Role: PRINCIPAL_INVESTIGATOR

AUBMC

Bassem Youssef, MD

Role: PRINCIPAL_INVESTIGATOR

AUBMC

Locations

American University of Beirut Medical Center

Beirut, , Lebanon

Countries

Lebanon

Central Contacts

Lara Hilal, MD

Role: CONTACT

lh54@aub.edu.lb

+96171233673

Zeinab Dandash, MD

Role: CONTACT

zd27@aub.edu.lb

+96170214930

Facility Contacts

Lara Hilal, MD

Role: primary

lh54@aub.edu.lb

+96171233673

Zeinab Dandash, MD

Role: backup

zd27@aub.edu.lb

+96170214930

Other Identifiers

BIO-2024-0045

Identifier Type: -

Identifier Source: org_study_id