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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Occurrence of a pain flare within the first 10 days after palliative radiation therapy [Срок оценки: From enrollment till 10 days after the start of palliative radiotherapy]

Вторичные конечные точки (1)

• Change in quality of life from start of palliative radiotherapy till one month after [Срок оценки: From enrollment till 30 days after the start of palliative radiotherapy]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Ливан · 1 центр

• American University of Beirut Medical Center — Beirut

Идентификаторы

NCT: NCT06903585 · BIO-2024-0045

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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