Predisposing Factors Associated With Chemotherapy Toxicity in Elderly Cancer Patients

Cancer Clinical Trial

Official title:

Predisposing Factors Associated With Chemotherapy Toxicity in Elderly Cancer Patients: A Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02317757
• Other study ID #: 559/2557(EC3)
• Status: Recruiting
• Phase: N/A
• First received: December 11, 2014
• Last updated: March 31, 2016
• Start date: January 2015
• Est. completion date: December 2016

Study information

• Verified date: March 2016
• Source: Mahidol University
• Contact: Suthinee Ithimakin, MD
• Phone: 66898127440
• Email: Aesi105[@]yahoo.co.th
• Is FDA regulated: No
• Health authority: Thailand: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

These days, there is higher proportion of elderly cancer patients. Most of them have comorbidities, borderline performance status and nutritional status. The discontinuation of chemotherapy due to unbearable toxicities was not uncommon. Comprehensive geriatric assessment might be beneficial in selection of suitable elderly patients for chemotherapy administration.

Description:

The patients with the age more than 70 years old who scheduled for chemotherapy were enrolled. Geriatric assessment was performed before starting chemotherapy. The toxicity will be recorded prospectively. Predisposing factors of grade 3 and 4 toxicity will be reported.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• more than 70 years of age

• plan to receive first cycle of chemotherapy

• histologically or cytologically proved of cancer

Exclusion Criteria:

• patients who have concurrent chemoradiotherapy

• patients who received local chemotherapy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
Thailand	Division of medical oncology, department of medicine Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	predisposing factors of patients developed grade 3 or 4 chemotherapy toxicity		from starting chemotherapy to 1 month after last dose of chemotherapy	No
Secondary	incidence of grade 3 or 4 chemotherapy toxicity in elderly		from starting chemotherapy to 1 month after last dose of chemotherapy	No
Secondary	Factors associated with good quality of life during receiving chemotherapy		from starting chemotherapy to 1 month after last dose of chemotherapy	No