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Not yet recruiting NCT06903585

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

Phase II Interventional Bone Pain Flare Bone Metastasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Naproxen (Proxen S), Placebo, Esomeprazole 20mg once daily.
Who it may be relevant to
Registry conditions: Bone Pain Flare, Bone Metastasis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Lebanon
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Non-steroidal Anti-inflammatory Drugs in the Prevention of Bone Pain Flares After Palliative Radiotherapy: A Randomized Controlled Trial

Overview

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.

Interventions

  • Drug 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.
  • 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.
  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Lebanon · 1 center
  • American University of Beirut Medical Center — Beirut

Identifiers

NCT: NCT06903585 · BIO-2024-0045

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗