Effect of Cabozantinib S-Malate or Lenvatinib Mesylate on Weight and Body Composition in Patients With Metastatic Endocrine Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02592356
Status
Completed

Conditions

  • Differentiated Thyroid Gland Carcinoma
  • Malignant Adrenal Gland Pheochromocytoma
  • Malignant Paraganglioma
  • Thyroid Gland Medullary Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Computed Tomography — PROCEDURE
    Correlative studies
  • Dual X-ray Absorptiometry — PROCEDURE
    Correlative studies
  • Physical Examination — PROCEDURE
    Correlative studies
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Cabozantinib — DRUG
  • Lenvatinib — DRUG

Study Details

The goal of this clinical research study is to learn about possible weight, muscle, and/or fat loss in patients receiving cabozantinib or lenvatinib.

Key Dates

Start date
Nov 16, 2015
Status verified
Mar 2024
Primary completion
Mar 1, 2024
Completion
Mar 1, 2024

Study Design

Enrollment
23 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Cabozantinib or Lenvatinib
    Patients treated with cabozantinib s-malate or lenvatinib mesylate are observed for body weight, skeletal muscle and adipose tissue changes. Patients complete 3 to 4 questionnaires every 2 weeks for 6 months and then monthly up to 12 months. Patients also undergo physical assessments and body composition measurements by DXA and CT scans at baseline, months 3, 6, and 12.

Primary Outcome Measure

Change in weight among patients who have no gastrointestinal (GI) adverse events (AEs) or have =< grade 1 symptoms and those with grade 2 or above AEs, according to the National Cancer Institute Common Toxicity Criteria version 4.0 [ Time Frame: Baseline to up to 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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By research site
M D Anderson Cancer Center· Houston, TX

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