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Body Mass Index (BMI) and Quality of Life (QoL) in Cancer Patients (BMI-QoL)

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ClinicalTrials.gov Identifier: NCT03873064
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : March 15, 2019
Sponsor:
Collaborator:
S.I.C.O.G. partners
Information provided by (Responsible Party):
Vincenzo Formica, University of Rome Tor Vergata

Brief Summary:

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 questionnaire in several cancer settings (such as localized vs metastatic or distinct primary tumors).


Condition or disease
Neoplasm Malignant Body Weight Quality of Life

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 1380 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Body Mass Index (BMI) and Quality of Life (QoL) in Cancer Patients
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022

Group/Cohort
patients with solid tumor
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/).



Primary Outcome Measures :
  1. relationship between BMI and EORTC-QLQC30 according to tumor stage [ Time Frame: Recruitment period of 36 months + follow-up period of 24 months since enrollment of last patient ]
    To assess the relationship between BMI and EORTC-QLQC30 scores in localized vs metastatic cancer patients


Secondary Outcome Measures :
  1. relationship between BMI and EORTC-QLQC30 according to different clinical settings other than stage [ Time Frame: Recruitment period of 36 months + follow-up period of 24 months since enrollment of last patient ]

    - To assess the relationship between BMI and EORTC-QLQC30 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study 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/).
Criteria

Inclusion Criteria:

  1. Histologically confirmed diagnosis of solid tumor
  2. Age >18 years
  3. Signed informed consent
  4. Life expectancy > 12 weeks

Exclusion Criteria:

  1. Inability to fill out the EORTC QLQ-C30 questionnaire.
  2. Absence of a certain diagnosis of solid tumor (e.g. subjects on screening programs)
  3. Diagnosis of second malignancies that might bias results interpretation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873064


Contacts
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Contact: Vincenzo Formica, MD, PhD +390620908190 v.formica1@gmail.com
Contact: Cristiano Serci +390620903247 cserci81@gmail.com

Locations
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Italy
Tor Vergata University Hospital Recruiting
Rome, Italy, 00133
Contact: Cristiano Serci    +390620908190      
Sponsors and Collaborators
University of Rome Tor Vergata
S.I.C.O.G. partners
Investigators
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Study Chair: Mario Roselli Tor Vergata University Hospital

Publications:

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Responsible Party: Vincenzo Formica, Consultant in Medical Oncology, Principal Investigator, University of Rome Tor Vergata
ClinicalTrials.gov Identifier: NCT03873064     History of Changes
Other Study ID Numbers: R.S. 102.17
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vincenzo Formica, University of Rome Tor Vergata:
BMI
EORTC QLQ-C30
metastatic cancer
localized cancer
Additional relevant MeSH terms:
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Body Weight
Neoplasms
Signs and Symptoms