Body Mass Index (BMI) and Quality of Life (QoL) in Cancer Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Rome Tor Vergata
About this trial
BMI is a simple and widely recorded variable that may capture obesity or cachexia in cancer patients. How BMI is associated to health-related quality of life (HR-QoL) in such patients is poorly investigated.
High BMI may be associated to obesity, an increased burden of comorbidity, reduced physical activity and, in some settings, to more aggressive oncological disease. On the other hand, low BMI may reflect enhanced weight loss, cachectic syndrome, higher tumor burden and adverse prognostic features which all deteriorate quality of life. The aim of the present study is to evaluate the association of BMI and HR-QoL as measured by the EORTC-QLQ-C30 or the EQ-5D-5L questionnaire in several cancer settings (such as localized vs metastatic or distinct primary tumors).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed diagnosis of solid tumor
Age >18 years
Signed informed consent
Life expectancy > 12 weeks
Disqualifiers
Inability to fill out the questionnaires.
Absence of a certain diagnosis of solid tumor (e.g. subjects on screening programs)
Diagnosis of second malignancies that might bias results interpretation
Trial population
All consecutive patients with a histologically confirmed diagnosis of solid tumor referred to any of the Medical Oncology Units of the S.I.C.O.G. cooperative group (http://www.sicog.it/).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,380 Participants
are grouped into 1 trial groupGroup A: patients with solid tumor
Trial outcomes
Primary outcomes
1
relationship between BMI and health-related quality-of-life scores according to tumor stage
To assess the relationship between BMI and health-related quality-of-life scores in localized vs metastatic cancer patients
Time frame
Recruitment period of 36 months + follow-up period of 24 months since enrollment of last patientSecondary outcomes
1
relationship between BMI and health-related quality-of-life scores according to different clinical settings other than stage
\- To assess the relationship between BMI and health-related quality-of-life scores according to: * primary tumor * presence vs absence of cardiovascular and/or metabolic comorbidities * Performance status * Ongoing chemotherapy treatment vs observation in disease-free patients (follow-up) * Other clinical and biochemical variables routinely assessed as common practice
Time frame
Recruitment period of 36 months + follow-up period of 24 months since enrollment of last patientSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Rome Tor Vergata
Lead sponsor
S.I.C.O.G. partners
Collaborator
Source ClinicalTrials.gov