Clinical trial · Interventional
Effect of Cabozantinib S-Malate or Lenvatinib Mesylate on Weight and Body Composition in Patients With Metastatic Endocrine Cancer
Effects of Tyrosine Kinase Inhibitors on Body Composition in Endocrine Tumors -- A Pilot Study
NCT02592356CI-TRIAL-00074671completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical research study is to learn about possible weight, muscle, and/or fat loss in patients receiving cabozantinib or lenvatinib.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Differentiated Thyroid Gland Carcinoma | Differentiated Thyroid Gland Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Malignant Adrenal Gland Pheochromocytoma | — | UNRESOLVED | — |
| Malignant Paraganglioma | — | UNRESOLVED | — |
| Thyroid Gland Medullary Carcinoma | Thyroid Gland Medullary Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cabozantinib | Drug | Cabozantinib | ALIAS |
| Computed Tomography | Procedure | — | UNRESOLVED |
| Dual X-ray Absorptiometry | Procedure | — | UNRESOLVED |
| Lenvatinib | Drug | Lenvatinib | ALIAS |
| Physical Examination | Procedure | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cabozantinib or Lenvatinib
- description
- 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.
- interventionNames
- Procedure: Computed Tomography
- Procedure: Dual X-ray Absorptiometry
- Procedure: Physical Examination
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Drug: Cabozantinib
- Drug: Lenvatinib
Primary outcomes (1)
- 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
- timeFrame
- Baseline to up to 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>/= 18 years * Initiating cabozantinib for progressive DTC, MTC, malignant PH or PGs or lenvatinib for progressive DTC or MTC as determined by patient's endocrinologist * ECOG performance status 0-2 * Able to communicate in English or Spanish * Able to provide informed consent Exclusion Criteria: * Active participation in any weight reduction program including use of drugs used for weight loss * Inability to ambulate without assistance (e.g. cane, walker) * Multiple Endocrine Neoplasia (MEN) 2B (due to differences in body habitus) * Patients unwilling or unable to comply with the protocol. * Use of chronic (\>3 months consecutively) non-physiological (15 mg/m² hydrocortisone equivalent) doses of glucocorticoids * Non-English speaking PH and PG patients
References
Publications (0)
Data not yet available
No reference posted for this study.