NCT03873064

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,380

participants targeted

Target at P75+ for all trials

Timeline
94mo left

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Jan 2019Jan 2034

Study Start

First participant enrolled

January 15, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2019

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2029

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2034

Last Updated

February 2, 2024

Status Verified

February 1, 2024

Enrollment Period

10 years

First QC Date

March 11, 2019

Last Update Submit

February 1, 2024

Conditions

Neoplasm MalignantBody WeightQuality of Life

Keywords

BMIEORTC QLQ-C30metastatic cancerlocalized cancer

Outcome Measures

Primary Outcomes (1)

  • relationship between BMI and EORTC-QLQC30 according to tumor stage

    To assess the relationship between BMI and EORTC-QLQC30 scores in localized vs metastatic cancer patients

    Recruitment period of 36 months + follow-up period of 24 months since enrollment of last patient

Secondary Outcomes (1)

  • relationship between BMI and EORTC-QLQC30 according to different clinical settings other than stage

    Recruitment period of 36 months + follow-up period of 24 months since enrollment of last patient

Study Arms (1)

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/).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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/).

You may qualify if:

  • Histologically confirmed diagnosis of solid tumor
  • Age \>18 years
  • Signed informed consent
  • Life expectancy \> 12 weeks

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tor Vergata University Hospital

Rome, 00133, Italy

RECRUITING

Related Publications (8)

  • Lin LL, Brown JC, Segal S, Schmitz KH. Quality of life, body mass index, and physical activity among uterine cancer patients. Int J Gynecol Cancer. 2014 Jul;24(6):1027-32. doi: 10.1097/IGC.0000000000000166.

    PMID: 24927246BACKGROUND

  • Martin L, Birdsell L, Macdonald N, Reiman T, Clandinin MT, McCargar LJ, Murphy R, Ghosh S, Sawyer MB, Baracos VE. Cancer cachexia in the age of obesity: skeletal muscle depletion is a powerful prognostic factor, independent of body mass index. J Clin Oncol. 2013 Apr 20;31(12):1539-47. doi: 10.1200/JCO.2012.45.2722. Epub 2013 Mar 25.

    PMID: 23530101BACKGROUND

  • Meyerhardt JA, Sloan JA, Sargent DJ, Goldberg RM, Pollak M, Morton RF, Ramanathan RK, Williamson SK, Findlay BP, Fuchs CS. Associations between plasma insulin-like growth factor proteins and C-peptide and quality of life in patients with metastatic colorectal cancer. Cancer Epidemiol Biomarkers Prev. 2005 Jun;14(6):1402-10. doi: 10.1158/1055-9965.EPI-04-0862.

    PMID: 15941948BACKGROUND

  • Renehan AG, Tyson M, Egger M, Heller RF, Zwahlen M. Body-mass index and incidence of cancer: a systematic review and meta-analysis of prospective observational studies. Lancet. 2008 Feb 16;371(9612):569-78. doi: 10.1016/S0140-6736(08)60269-X.

    PMID: 18280327BACKGROUND

  • Twig G, Yaniv G, Levine H, Leiba A, Goldberger N, Derazne E, Ben-Ami Shor D, Tzur D, Afek A, Shamiss A, Haklai Z, Kark JD. Body-Mass Index in 2.3 Million Adolescents and Cardiovascular Death in Adulthood. N Engl J Med. 2016 Jun 23;374(25):2430-40. doi: 10.1056/NEJMoa1503840. Epub 2016 Apr 13.

    PMID: 27074389BACKGROUND

  • Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.

    PMID: 8433390BACKGROUND

  • A'Hern RP. Sample size tables for exact single-stage phase II designs. Stat Med. 2001 Mar 30;20(6):859-66. doi: 10.1002/sim.721.

    PMID: 11252008BACKGROUND

  • Smits A, Lopes A, Das N, Bekkers R, Galaal K. The impact of BMI on quality of life in obese endometrial cancer survivors: does size matter? Gynecol Oncol. 2014 Jan;132(1):137-41. doi: 10.1016/j.ygyno.2013.11.018. Epub 2013 Nov 18.

    PMID: 24262880BACKGROUND

MeSH Terms

Conditions

NeoplasmsBody WeightNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsNeoplastic ProcessesPathologic Processes

Study Officials

  • Mario Roselli

    Tor Vergata University Hospital

    STUDY CHAIR

Central Study Contacts

Vincenzo Formica, MD, PhD

CONTACT

+390620908190v.formica1@gmail.com

Cristiano Serci

CONTACT

+390620903247cserci81@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant in Medical Oncology, Principal Investigator

Study Record Dates

First Submitted

March 11, 2019

First Posted

March 13, 2019

Study Start

January 15, 2019

Primary Completion (Estimated)

January 15, 2029

Study Completion (Estimated)

January 15, 2034

Last Updated

February 2, 2024

Record last verified: 2024-02

Locations

IT(1)