Predisposing Factors Associated With Chemotherapy Toxicity in Elderly Cancer Patients

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

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.

Study Overview

• Status: Unknown
• Conditions: Cancer

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Suthinee Ithimakin, MD; Phone Number: 66898127440; Email: Aesi105@yahoo.co.th

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Recruiting
    • Division of medical oncology, department of medicine Siriraj Hospital
    • Contact: Suthinee Ithimakin, MD; Phone Number: 662-419-4489; Email: aesi105@yahoo.co.th
    • Principal Investigator: Suthinee Ithimakin, MD
    • Sub-Investigator: Varalak Srinonprasert, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

cancer patients who are older than 70 years old and receiving chemotherapy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
cancer patients receiving chemotherapy; Patients who are older than 70 years old receiving chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
predisposing factors of patients developed grade 3 or 4 chemotherapy toxicity	from starting chemotherapy to 1 month after last dose of chemotherapy

Secondary Outcome Measures

Outcome Measure	Time Frame
incidence of grade 3 or 4 chemotherapy toxicity in elderly	from starting chemotherapy to 1 month after last dose of chemotherapy
Factors associated with good quality of life during receiving chemotherapy	from starting chemotherapy to 1 month after last dose of chemotherapy

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Suthinee Ithimakin, MD, Mahidol University

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: December 11, 2014
• First Submitted That Met QC Criteria: December 11, 2014
• First Posted (Estimate): December 16, 2014

Study Record Updates

• Last Update Posted (Estimate): April 4, 2016
• Last Update Submitted That Met QC Criteria: March 31, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: elderly cancer patients, chemotherapy toxicity
• Other Study ID Numbers: 559/2557(EC3)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO