An observational study in Neoplasm Malignant, Body Weight and Quality of Life, sponsored by University of Rome Tor Vergata. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by University of Rome Tor Vergata · Observational
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).
Health-related quality of life (HRQoL) might have a varied association with body weight in patients with solid cancer[1].
On one hand, low body weight may reflect cancer-related anorexia and weight loss and cachectic syndrome, which are associated with impaired performance status, deteriorated general conditions, and advanced cancer[2]. In such patients, the probability of recording a low Body Mass Index (BMI) and, concomitantly, an inferior health-related quality of life (HRQoL, as a patient reported outcome, PRO) is high.
On the other hand, some of the hormonal mediators found at increased concentration in obese patients, such as insulin-like growth factor (IGF), have been demonstrated to be involved in biological pathways that favor improved HRQoL[3].
An additional apparent contradiction is that obesity and high BMI may represent in some cancer settings an adverse feature. In particular, obesity is associated with an increased risk of developing certain tumor types and, in some cancer patients with radically resected primary tumors, of cancer relapse[4]. Moreover high BMI is often associated with an increased burden of comorbidity (e.g. cardiovascular and metabolic diseases)[5] and reduced physical activity. All these factors may reduce HRQoL.
Studies investigating specific associations between BMI and HRQoL in specific cancer settings are therefore warranted.
The present prospective observational cohort study aims to investigate the relationship between BMI and PRO-HRQoL as measured by the EORTC-QLQ-C30 or the EQ-5D-5L questionnaire [6] in different primary tumors (breast, lung, colorectal and others) and in different cancer stages (localized vs metastatic). Patients will also be stratified according to the presence of cardiovascular and metabolic comorbidities, the Karnofsky Performance status, and the oncological treatment received (systemic treatment vs radically resected patients on follow-up). If available, retrospective data will be used to train possible predictive models.
STUDY PROCEDURES Study participation will be offered to all consecutive patients with a histologically confirmed diagnosis of solid tumor referred to the Medical Oncology Units of the S.I.C.O.G. cooperative group (http://www.sicog.it/). Upon acceptance, patients will sign an informed consent forms and be asked to fill out the EORTC QLQ C30 or EQ-5D-5L questionnaire.
All common anthropometric, demographic, clinical, and biochemical variables will be recorded at the time of first referral (within three months).
Re-assessable variables, including re-administration of the EORTC QLQ-C30/EQ-5D-5L questionnaire, will be recorded every 4-6 months thereafter. All data will be stored in a prospectively maintained database.
Among recorded data will be: age, sex, weight, height, occupation, marital status, primary tumor site, tumor stage, possible metastatic sites, past and current type of oncological treatment, concomitant medications, Karnofsky Performance Status, vital signs, and routine and clinically relevant blood tests.
Patients will be oncologically managed according to standard practice. If indicated, patients will also be asked to provide consent for peripheral blood sampling for immune response evaluation. Association between BMI and PROs will be assessed using regression analyses across the different clinical settings identified.
STATISTICAL CONSIDERATIONS The design of the study hypothesizes that in metastatic patients an improved HR-QoL is associated with high BMI (non-cachectic patients) An 'exact single-stage design' will be followed [7]. According to historical data (endometrial cancer), 50% of patients with BMI \< 30 have a high global health status score (GHS) of the EORTC QLQ C30 (i.e. a GHS score ≥ 80%, which would correspond to a EQ-5D-5L index ≥ 0.85) [8].
The hypothesis to be tested will be H0, P \< P0 vs H1, P > P1, where P is the percentage of patients with GHS ≥ 80%. A one-tail alpha error of 0.05 and false-negative (beta) rate of 0.2 will be considered. P0 will be set at 50% and P1 at 65%, looking for a 15% increase in the percentage of high GHS scores among patients with BMI >30. The H0 hypothesis will be rejected and H1 accepted with a statistical power of 80% if at least 42 patients out of 69 with BMI > 30 report a GHS score ≥ 80.
Since BMI > 30 is observed in about 10% of all metastatic patients, a total of 690 metastatic patients will be required. Since metastatic patients represent about half of all cancer patients referred to Medical Oncology Units, a final sample size of 1380 cancer patients (all stages) will be set as the target number. Secondary analyses will evaluate the extent to which clinical and biochemical characteristics documented during the observation period moderate the association between BMI and HRQoL. Additionally, these analyses will quantify the relative contributions of both BMI and HRQoL to anticancer treatment outcomes and overall survival.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 1,380 is above the median of 200 across 2,638 observational studies indexed under Neoplasms.
Browse Neoplasms studies →University of Rome Tor Vergata is the lead sponsor of 96 studies on the registry; 20 are open to participants now.
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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/).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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/).
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 patient
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 patient
Plan to share: Undecided
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University of Rome Tor Vergata