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A Study Comparing Chemotherapy Dosing Based on Either Standard Body Surface Area or Lean Body Mass in Patients With Advanced Lung Cancer

NCT01624051 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2014-09-30

No results posted yet for this study

Summary

Cancer patients are highly variable in their body composition, specifically in the proportion of fat and muscle. Some patients tend to gain fat and lose muscle (or lean body mass) at the same time. These patients can develop severe muscle wasting, termed sarcopenia. Patients with sarcopenia have more severe treatment related toxicity requiring delays, dose reductions and stopping of treatment, and have reduced survival. One potential explanation for this is that patients with sarcopenia have a reduced volume of lean body mass into which chemotherapy drugs are distributed, resulting in a higher concentration and greater toxicity. This study will randomize lung cancer patients to either the standard dosing strategy based on body surface area or experimental, personalized dosing based on lean body mass. Based on retrospective findings in this patient population, the investigators expect to find that severe toxicity will be reduced for sarcopenic patients on the personalized dosing arm based on lean body mass.

Conditions

Interventions

OTHER

Standard dosing method arm: Cisplatin (chemotherapy) dosing based on body surface area

Cisplatin dosing calculated at the rate of 75 mg/m2

OTHER

Experimental dosing method arm: Cisplatin (chemotherapy) dosing based on individual lean body mass

Cisplatin dosing calculated at the rate of 3.10 mg/kg lean body mass

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • AHS Cancer Control Alberta

    lead OTHER

Principal Investigators

  • Michael B Sawyer, MD · Medical Oncologist, Cross Cancer Institute

  • Vickie Baracos, PhD · Grant Holder, Department of Oncology, University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01624051 on ClinicalTrials.gov