The Palliative Radiotherapy And Inflammation Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

580 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2018-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Neoplasm Metastasis Bone Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Radiation therapy for bone cancer pain

The group includes all cancer diagnoses, and different fractions of RT planned.

Palliative RT for bone cancer pain

Intervention Type RADIATION

Interventions

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Palliative RT for bone cancer pain

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No