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

Quality of Life Clinical Trial

— BMI-QoL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03873064
• Other study ID #: R.S. 102.17
• Status: Recruiting
• Start date: January 15, 2019
• Est. completion date: January 15, 2034

Study information

• Verified date: February 2024
• Source: University of Rome Tor Vergata
• Contact: Vincenzo Formica, MD, PhD
• Phone: +390620908190
• Email: v.formica1[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

Health-related quality of life (HRQoL) might have varied association to 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 to 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 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 HRQoL[3].

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 relapse[4]. Moreover high BMI carries often 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 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 S.I.C.O.G. cooperative group (http://www.sicog.it/). 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 (i.e. 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 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1380
• Est. completion date: January 15, 2034
• Est. primary completion date: January 15, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Neoplasm Malignant
• Neoplasms
• Quality of Life

Locations

Country	Name	City	State
Italy	Tor Vergata University Hospital	Rome

Sponsors (2)

Lead Sponsor	Collaborator
University of Rome Tor Vergata	S.I.C.O.G. partners

Country where clinical trial is conducted

Italy, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	relationship between BMI and EORTC-QLQC30 according to different clinical settings other than stage	- 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	Recruitment period of 36 months + follow-up period of 24 months since enrollment of last patient