Clinical trial · Observational
Body Mass Index (BMI) and Quality of Life (QoL) in Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Body Weight | — | UNRESOLVED | — |
| Neoplasm Malignant | Malignant Neoplasm | ALIAS | 0.90 |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- patients with solid tumor
- description
- 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 outcomes (1)
- measure
- relationship between BMI and health-related quality-of-life scores according to tumor stage
- timeFrame
- Recruitment period of 36 months + follow-up period of 24 months since enrollment of last patient
- description
- To assess the relationship between BMI and health-related quality-of-life scores in localized vs metastatic cancer patients
Secondary outcomes (1)
- measure
- relationship between BMI and health-related quality-of-life scores according to different clinical settings other than stage
- timeFrame
- Recruitment period of 36 months + follow-up period of 24 months since enrollment of last patient
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 questionnaires. 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
References
Publications (8)
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- BACKGROUNDMartin 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 23530101
- BACKGROUNDMeyerhardt 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 15941948
- BACKGROUNDRenehan 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 18280327
- BACKGROUNDTwig 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 27074389
- BACKGROUNDAaronson 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.