Assessment of Patient Frailty Prior to Thoracic Surgery

Lung Cancer Clinical Trial

Official title:

Assessment of Patient Frailty Prior to Thoracic Surgery: A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02803281
• Other study ID #: 15-9170
• Status: Completed
• Start date: July 29, 2015
• Est. completion date: November 21, 2018

Study information

• Verified date: May 2019
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Determine the feasibility of assessment of measures of frailty and determine if these measures provide a clinically important contribution of risk assessment in a population of patients undergoing major thoracic surgery for lung or esophageal cancer.

Description:

Both gastro-esophageal and lung cancers are major causes of morbidity and mortality worldwide. In Canada the incidence for Esophageal Adenocarcinoma has doubled in the last two decades, while lung cancer is the leading cause of cancer death. Surgery is a treatment option for these patients; however, esophagectomy in particular, is associated with significant morbidity, mortality and adverse effect on quality of life. Despite satisfactory standard preoperative testing to evaluate risk for surgery, some patients experience morbidity and never recover fully from surgery. Frailty assessment may offer a more sensitive measure of a patient's physiologic reserve, which may allow identification of patients who are poor candidates for surgery. There is a lack of consensus of how best to assess frailty prior to surgery. This study aims to analyze frailty assessment as a tool for patient selection for surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 21, 2018
• Est. primary completion date: July 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with Esophageal or Lung Cancer who will undergo resectional surgery.

Exclusion Criteria:

• Patients undergoing diagnostic or staging procedures or pulmonary wedge excisions will be excluded.

• Patients unable to give informed consent

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Frailty
• Lung Cancer

Intervention

Other:
• Frailty Assessment
Various physiologic and frailty assessment tests

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario
Canada	University Health Network (Toronto General Hospital)	Toronto	Ontario
Canada	University Health Network: Toronto General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (10)

Chen CH, Ho-Chang, Huang YZ, Hung TT. Hand-grip strength is a simple and effective outcome predictor in esophageal cancer following esophagectomy with reconstruction: a prospective study. J Cardiothorac Surg. 2011 Aug 15;6:98. doi: 10.1186/1749-8090-6-98. — View Citation

Fritz S, Lusardi M. White paper: "walking speed: the sixth vital sign". J Geriatr Phys Ther. 2009;32(2):46-9. Erratum in: J Geriatr Phys Ther. 2009;32(3):110. — View Citation

Hodari A, Hammoud ZT, Borgi JF, Tsiouris A, Rubinfeld IS. Assessment of morbidity and mortality after esophagectomy using a modified frailty index. Ann Thorac Surg. 2013 Oct;96(4):1240-1245. doi: 10.1016/j.athoracsur.2013.05.051. Epub 2013 Jul 31. — View Citation

Makary MA, Segev DL, Pronovost PJ, Syin D, Bandeen-Roche K, Patel P, Takenaga R, Devgan L, Holzmueller CG, Tian J, Fried LP. Frailty as a predictor of surgical outcomes in older patients. J Am Coll Surg. 2010 Jun;210(6):901-8. doi: 10.1016/j.jamcollsurg.2010.01.028. Epub 2010 Apr 28. — View Citation

Roberts HC, Denison HJ, Martin HJ, Patel HP, Syddall H, Cooper C, Sayer AA. A review of the measurement of grip strength in clinical and epidemiological studies: towards a standardised approach. Age Ageing. 2011 Jul;40(4):423-9. doi: 10.1093/ageing/afr051. Epub 2011 May 30. Review. — View Citation

Robinson TN, Eiseman B, Wallace JI, Church SD, McFann KK, Pfister SM, Sharp TJ, Moss M. Redefining geriatric preoperative assessment using frailty, disability and co-morbidity. Ann Surg. 2009 Sep;250(3):449-55. doi: 10.1097/SLA.0b013e3181b45598. — View Citation

Rogalla P, Meiri N, Hoksch B, Boeing H, Hamm B. Low-dose spiral computed tomography for measuring abdominal fat volume and distribution in a clinical setting. Eur J Clin Nutr. 1998 Aug;52(8):597-602. — View Citation

Sheetz KH, Zhao L, Holcombe SA, Wang SC, Reddy RM, Lin J, Orringer MB, Chang AC. Decreased core muscle size is associated with worse patient survival following esophagectomy for cancer. Dis Esophagus. 2013 Sep-Oct;26(7):716-22. doi: 10.1111/dote.12020. Epub 2013 Jan 25. — View Citation

Talsma AK, Damhuis RA, Steyerberg EW, Rosman C, van Lanschot JJ, Wijnhoven BP. Determinants of improved survival after oesophagectomy for cancer. Br J Surg. 2015 May;102(6):668-75. doi: 10.1002/bjs.9792. Epub 2015 Mar 18. — View Citation

Yano Y, Inokuchi T, Kario K. Walking speed is a useful marker of frailty in older persons. JAMA Intern Med. 2013 Feb 25;173(4):325-6. doi: 10.1001/jamainternmed.2013.1629. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility Assessment	Determine the feasibility of assessment of measures of frailty and determine if these measures provide a clinically important contribution of risk assessment in a population of patients undergoing major thoracic surgery for lung or esophageal cancer.	2 years

External Links

•   Canadian Cancer Statistics 2010