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

NCT06903585 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: BIO-2024-0045
• Study Type: interventional
• Target: 385
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Occurrence of a pain flare within the first 10 days after palliative radiation therapy

  Subjects will be monitored for the occurrence of a pain flare during the first 10 days after the start of their palliative radiotherapy through daily phone calls by the research fellow who will ask the necessary questions to fill out the Brief Pain Inventory questionnaire and compare baseline pain scores to follow-up pain scores. This questionnaire has a minimum score of 0 and maximum score of 110, with higher scores indicating more pain. A pain flare will be considered positive if there is: * Two-point increase from baseline on a pain scale from 0-10 with no increase in analgesic medication intake OR * At least 25% increase in the intake of analgesic (daily oral morphine) with no decrease in pain scores on a pain scale

  From enrollment till 10 days after the start of palliative radiotherapy

Secondary Outcomes (1)

• Change in quality of life from start of palliative radiotherapy till one month after

  From enrollment till 30 days after the start of palliative radiotherapy

Study Arms (2)

NSAID arm

ACTIVE COMPARATOR

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.

Drug: Naproxen (Proxen S); Drug: Esomeprazole 20mg once daily

Placebo arm

PLACEBO COMPARATOR

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.

Drug: Placebo; Drug: Esomeprazole 20mg once daily

Interventions

Naproxen (Proxen S) 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.

Also known as: NSAIDs

NSAID arm

Placebo 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.

Placebo arm

Esomeprazole 20mg once daily 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.

Also known as: PPI, Nexium

NSAID arm; Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical Center

Beirut, 1107 - 2020, Lebanon

Location

MeSH Terms

Interventions

Naproxen; Anti-Inflammatory Agents, Non-Steroidal; Esomeprazole

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Lara Hilal, MD

  AUBMC

  PRINCIPAL INVESTIGATOR

• Bassem Youssef, MD

  AUBMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lara Hilal, MD

CONTACT

+96171233673; lh54@aub.edu.lb

Zeinab Dandash, MD

CONTACT

+96170214930; zd27@aub.edu.lb

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: March 31, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

LE (1)