Ignite Creation Date:
2024-05-06 @ 12:53 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03873064
Status:
RECRUITING
Last Update Posted:
2024-02-02
First Post:
2019-03-11
Brief Title:
Body Mass Index BMI and Quality of Life QoL in Cancer Patients
Sponsor:
University of Rome Tor Vergata
Organization:
University of Rome Tor Vergata
Study Overview
Official Title:
Body Mass Index BMI and Quality of Life QoL in Cancer Patients
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BMI-QoL
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
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
Detailed Description:
Health-related quality of life HRQoL might have varied association to body weight in patients with solid cancer1
On one hand low body weight may reflect cancer-related anorexia and weight loss and cachectic syndrome which are associated to impaired performance status deteriorated general conditions and advanced cancer2 In such patients the probability of recording a low Body Mass Index BMI and concomitantly an inferior Health related quality of life HRQoL as 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 an improved HRQoL3
Adding further apparent contradiction is the fact 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 of cancer relapse4 Moreover high BMI carries often an increased burden of comorbidity eg cardiovascular and metabolic diseases5 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 has the aim of investigating the relationship between BMI and PRO-HRQoL as measured by the EORTC-QLQ-C30 questionnaire 6 in different primary tumors breast lung colorectal and others and in different cancer stages localized vs metastatic Patients will be also stratified according to the presence of cardiovascular and metabolic comorbidities to the Karnofsky Performance status and according to the oncological treatment received chemotherapy 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 SICOG cooperative group httpwwwsicogit Upon acceptance patients will sign an informed consent and be asked to fill out the EORTC QLQ C30 questionnaire
All common antropometric demographic clinical and biochemical variables will be recorded around the moment of first referral within three months
Re-assessable variables including EORTC QLQ-C30 questionnaire re-administration 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 civil status primary tumor site tumor stage possible metastatic sites past and actual type of oncological treatment pain score Karnofsky Performance Status vital signs routine blood tests Patients will be oncologically managed according to standard practice Association between BMI and EORTC QLQ-C30 will be assesses 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 has a high global health status score GHS of the EORTC QLQ C30 ie a GHS score 80 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 One-tail alpha error of 005 and false-negative beta rate of 02 will be considered P0 will be set at 50 and P1 at 65 looking for a 15 increase in the percentage of high GHS score 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 will 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 are 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
On one hand low body weight may reflect cancer-related anorexia and weight loss and cachectic syndrome which are associated to impaired performance status deteriorated general conditions and advanced cancer2 In such patients the probability of recording a low Body Mass Index BMI and concomitantly an inferior Health related quality of life HRQoL as 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 an improved HRQoL3
Adding further apparent contradiction is the fact 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 of cancer relapse4 Moreover high BMI carries often an increased burden of comorbidity eg cardiovascular and metabolic diseases5 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 has the aim of investigating the relationship between BMI and PRO-HRQoL as measured by the EORTC-QLQ-C30 questionnaire 6 in different primary tumors breast lung colorectal and others and in different cancer stages localized vs metastatic Patients will be also stratified according to the presence of cardiovascular and metabolic comorbidities to the Karnofsky Performance status and according to the oncological treatment received chemotherapy 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 SICOG cooperative group httpwwwsicogit Upon acceptance patients will sign an informed consent and be asked to fill out the EORTC QLQ C30 questionnaire
All common antropometric demographic clinical and biochemical variables will be recorded around the moment of first referral within three months
Re-assessable variables including EORTC QLQ-C30 questionnaire re-administration 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 civil status primary tumor site tumor stage possible metastatic sites past and actual type of oncological treatment pain score Karnofsky Performance Status vital signs routine blood tests Patients will be oncologically managed according to standard practice Association between BMI and EORTC QLQ-C30 will be assesses 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 has a high global health status score GHS of the EORTC QLQ C30 ie a GHS score 80 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 One-tail alpha error of 005 and false-negative beta rate of 02 will be considered P0 will be set at 50 and P1 at 65 looking for a 15 increase in the percentage of high GHS score 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 will 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 are 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None