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NCT Number: NCT02107664

The Palliative Radiotherapy And Inflammation Study - PRAIS

Radiation therapy (RT) is one of the primary treatments for bone cancer pain due to metastatic cancer disease. About 6 of 10 patients obtain pain relief from RT. There are no established predictors that can be used to select patients that respond to RT. This raises the need to identify potential clinical characteristics and biomarkers that may better select patients for RT. A similar argument can be stated for the development of cachexia; there are currently no predictors that can identify patients who will develop cachexia later in the cancer disease trajectory. Cancer symptoms can be related to inflammation. Both pain, cachexia and depression are associated with inflammation in experimental and preclinical studies . Still, the clinical data on the relationship between inflammation and pain or cachexia are sparse. This is especially true for longitudinal follow-up studies.

This study will include 1000 adult patients in a multicenter, multinational longitudinal observation study of patients who receive radiation therapy for bone cancer pain. Demographic data, clinical variables, genetic biomarkers and inflammatory substances will be assessed before start of RT. The primary analysis in the study is to identify potential predictors for pain relief from RT. During follow up the study will also explore for predictors for development of cachexia and which inflammatory substances that are associated with changes in pain intensity, depression and development of cachexia.

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Key information

Conditions

Neoplasm Metastasis Behavior Behavioral Symptoms Body Weight Body Weight Changes Bone Diseases Bone Neoplasms Cachexia Depression Inflammation Musculoskeletal Diseases Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Thinness Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept of Oncology, Oslo Universitetssykehus, Oslo, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Verified cancer diagnosis (based on radiological, histological, cytological or operative evidence). Those with hematological malignancies are also eligible.
  • Bone metastasis verified either by bone x-ray, bone scan, computer tomography (CT) or magnetic resonance imaging (MRI)
  • Patients that are about to undergo radiotherapy with palliative intent for painful bone metastasis
  • Radiotherapy should be administered within one week after baseline observations are obtained
  • Age ≥18 years
  • Patient is able to comply with trial procedures.

Exclusion criteria

  • Pathological fracture in long bones (e.g femora or humeral shaft fractures)
  • Patients not consenting to participate in the study
  • On-going RT or RT administered within the last 4 weeks
  • Patients who are not able to follow the trial procedures
  • Previous participation in this study

Treatment and study plan

Palliative RT for bone cancer pain

Radiation

Primary outcomes

  1. Pain response

    Time frame: 3 - 8 weeks

    Complete response implies a numeric rate scale (NRS) worst pain of zero at the treated site on an 11-point rating scale, with no concomitant increase in analgesic intake.

    Partial response is defined as either i) pain reduction of two or more at the treated site on the 11-point NRS worst pain rating scale together with no increase in analgesic intake, or ii) reduction in analgesic intake of at least 25 per cent from baseline without an increase in pain score at the treated site.

    An "intermediate response" category represents any response other than complete or partial response or pain progression

Secondary outcomes

  1. Cachexia

    Time frame: 1 year

    Cachexia defined as a) Weight loss >5% over past 6 months (in absence of simple starvation); or b) body mass index (BMI) <20 and any degree of weight loss >2%; or c) Appendicular skeletal muscle index consistent with sarcopenia (males <7・26 kg/m2; females <5・45 kg/m2) and any degree of weight loss >2%

  2. Depression

    Time frame: 1 year

    Depression symptoms last 2 weeks scored i patient Health Questionnaire (PHQ) - 9.

Other outcomes

  1. Inflammatory Biomarkers

    Time frame: 1 year

    Change in inflammatory biomarkers during longitudinal follow-up in relation to change in pain, depression and cachexia.

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Alesund Hospital
  • European Association for Palliative Care
  • Oslo University Hospital
  • St. Olavs Hospital

Registry information

Official study title

The Palliative Radiotherapy And Inflammation Study: Palliative Radiotherapy of Bone Metastasis. Classification, Inflammatory Biomarkers, and Longitudinal Clinical Follow-up

Acronym: PRAIS

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Apr 8, 2014
Registry last updated
Mar 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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