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Alkylating agents

Lean Body Mass Dosing for Lung Cancer

Phase 2
Waitlist Available
Led By Michael B Sawyer, MD
Research Sponsored by AHS Cancer Control Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed every 60 days from the date of removal from the trial (an expected average of 9 months)
Awards & highlights

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.

Eligible Conditions
  • Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed every 60 days from the date of removal from the trial (an expected average of 9 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 60 days from the date of removal from the trial (an expected average of 9 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose limiting toxicity rates
Number of Cycles completed
Secondary outcome measures
Survival

Side effects data

From 2014 Phase 4 trial • 45 Patients • NCT02000531
29%
Nausea
19%
Leukopenia
14%
White blood cell count decreased
14%
Vomiting
14%
Thrombocytopenia
14%
Alanine aminotransferase increased
14%
Anaemia
14%
Neutropenia
10%
Neutrophil count decreased
10%
Platelet count decreased
10%
Aspartate aminotransferase increased
5%
Dizziness
5%
Back pain
5%
Diarrhea
5%
Musculoskeletal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erlotinib-Chemotherapy
Chemotherapy-Erlotinib

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Lean Body Mass DosingExperimental Treatment1 Intervention
Experimental dosing arm based on individual lean body mass
Group II: Body Surface Area DosingActive Control1 Intervention
Standard dosing arm based on body surface area

Find a Location

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,348 Previous Clinical Trials
26,455,441 Total Patients Enrolled
AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
36,068 Total Patients Enrolled
Michael B Sawyer, MDPrincipal InvestigatorMedical Oncologist, Cross Cancer Institute
2 Previous Clinical Trials
105 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~13 spots leftby May 2025