Bone Pain FlarePhase 2NCT06903585
Non Steroidal Anti-inflammatory Drugs in the Prevention of Bone Pain Flares After Palliative Radiotherapy
A Phase 2 study testing Naproxen (Proxen S) and Esomeprazole 20mg once daily in people with Bone Pain Flare and Bone Metastasis, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Pain Flare, Bone Metastasis
- What is being tested?
- Naproxen (Proxen S) and Esomeprazole 20mg once daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 385 participants
- Where
- 1 siteLebanon
- Study dates
- Apr 2025to Apr 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lebanon1 site
American University of Beirut Medical Center
Beirut, 1107 - 2020
Lara Hilal, MD, +96171233673, lh54@aub.edu.lb
Zeinab Dandash, MD, +96170214930, zd27@aub.edu.lb
About this study
Official title: Non-steroidal Anti-inflammatory Drugs in the Prevention of Bone Pain Flares After Palliative Radiotherapy: A Randomized Controlled Trial
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
- Being tested
- Naproxen (Proxen S), Placebo, Esomeprazole 20mg once daily
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naproxen (Proxen S)Drug
Also called NSAIDs
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.
PlaceboDrug
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 dailyDrug
Also called PPI, Nexium
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo; Drug: Esomeprazole 20mg once daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Quality of life scores will be assessed through daily phone calls to the subjects performed by the research fellow who will ask the subjects the necessary questions to fill out the European Organization for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-BM22) and compare the baseline scores to the recent ones. This questionnaire has a minimum score of 22 and a maximum score of 88, with higher scores indicating greater distress and hence lower quality of life. The phone calls will be daily the first 10 days after start of palliative radiotherapy, and then weekly for a total of 30 days after the start of palliative radiotherapy.
Measured: From enrollment till 30 days after the start of palliative radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2025
- Study startApr 2025 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Pain FlareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 385 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lara Hilal, American University of Beirut Medical Center
- Investigators
- Lara Hilal, MD, Principal investigator, AUBMCBassem Youssef, MD, Principal investigator, AUBMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903585
- Sponsor's protocol ID
- BIO-2024-0045
- Status last verified
- Apr 2025
- First submitted
- 25 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-steroidal Anti-inflammatory Drugs in the Prevention of Bone Pain Flares After Palliative Radiotherapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06903585
- Acronym / sponsor ID
- BIO-2024-0045
- Conditions
- Bone Pain Flare, Bone Metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 385 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 31 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSAID arm | Active comparator | Drug: Naproxen (Proxen S), Drug: Esomeprazole 20mg once dailyPeople 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. |
| Placebo arm | Placebo comparator | Drug: Placebo, Drug: Esomeprazole 20mg once dailyPeople 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naproxen (Proxen S)Also: NSAIDsNaproxen 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. | Drug | NSAID arm |
| PlaceboPlacebo 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. | Drug | Placebo arm |
| Esomeprazole 20mg once dailyAlso: PPI, NexiumEsomeprazole 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. | Drug | NSAID arm, Placebo arm |
Primary outcome
Occurrence of a pain flare within the first 10 days after palliative radiation therapy
Time frame: From enrollment till 10 days after the start of palliative radiotherapy
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
1 secondary outcome
Change in quality of life from start of palliative radiotherapy till one month after
Time frame: From enrollment till 30 days after the start of palliative radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lara Hilal, MD principal investigator
AUBMC
Bassem Youssef, MD principal investigator
AUBMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Naproxen (Proxen S) and Esomeprazole 20mg once daily in people with Bone Pain Flare and Bone Metastasis, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lara Hilal, MD (+96171233673, lh54@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of a pain flare within the first 10 days after palliative radiation therapy (time frame: From enrollment till 10 days after the start of palliative radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.