SYmptom Study of radioThErapy in MeSothelioma | Not Recruiting
SYmptom Study of radioThErapy in MeSothelioma
SYSTEMS
Trial Source

Health Conditions
  • Malignant pleural mesothelioma (MPM)
Not Recruiting
Recruitment Status
ISRCTN10644347
Primary Trial ID Number
Summary
The aim of the SYSTEMS study is to assess the effect of radiotherapy on key symptoms in patients with mesothelioma (e.g. pain) using comprehensive and validated symptom assessment measures.
Primary Outcome Measures
  • This research will assess if radiotherapy is beneficial in treating pain in malignant pleural mesothelioma (MPM).
Secondary Outcome Measures
  • 1. To assess whether radiotherapy improves other symptoms (dyspnoea, fatigue, distress) using a number of validated questionnaires
  • 2. Possible biomarkers will be examined and the relationship between inflammation and symptoms explored
Research Question
  • The aim of the SYSTEMS study is to assess the effect of radiotherapy on key symptoms in patients with mesothelioma (e.g. pain) using comprehensive and validated symptom assessment measures.
Design Type
Sorry, this information is not available
Ethics Approval
Not provided at time of registration
Publications
Sorry, this information is not available
Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
Adult
Participant Type
Patient
Trial Sample Size
42
Participant Inclusion Criteria
  • 1. >/=18 years of age.
  • 2. Histological or multi-disciplinary team (MDT) diagnosis of mesothelioma
  • 3. Able to complete study assessments
  • 3. Life expectancy of at least 3 months based on clinical judgement
  • 4. Due to receive radiotherapy for pain resulting from mesothelioma (defined as index site – site of radiotherapy)
  • 5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • 6. CT scan within 6 weeks of radiotherapy
  • 7. Worst pain >4/10 (0-10 Visual Analogue Scale) corresponding to the index site
Participant Exclusion Criteria
  • 1. Received chemotherapy or radiotherapy in the preceding six weeks that is likely to alter pain at the index site during the duration of the study
  • 2. Planned chemotherapy during the period of the study that is likely to alter pain during the course of the study
  • 3. Psychotic disorders or cognitive impairment
  • 4. Co-existing lung tumours at the time of study entry
  • 5. Pregnant or breastfeeding
Interventions
The symtoms will be measured using validated questionnaires at end of radiotherapy treatment (week 1), at week 5 and week 12 (final study visit)
Design Details
Sorry, this information is not available
Study Design
Single arm phase II observational study
Results Reporting
Sorry, this information is not available
Acronym
SYSTEMS
Scientific Title
A single arm observational SYmptom Study of radioThErapy in MeSothelioma
Secondary Trial Identifying Number
SYSTEMS2012
Website
Sorry, this information is not available
Study Funded By
June Hancock Mesothelioma Research Fund (UK)
Funder Type
Sorry, this information is not available
Study Sponsored By
NHS Greater Glasgow and Clyde (UK)
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment

14 Jun 2012

Recruitment End Date

15 Dec 2013

Trial End Date

15 Dec 2013

Date added to Registry

03 Aug 2012

Last Updated

30 Oct 2012