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

NCT02592356 | Completed

• 2 other identifiers: 2014-0864NCI-2015-02058
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• 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

  2-sided paired t-test will be used to measure weight change after successful intervention of diarrhea and anorexia. Linear mixed-effects model will be used to explore the longitudinal weight changes. Summary descriptive statistics, including proportions, medians, means, 95% confidence intervals, and other simple statistics will be provided for demographics, gastrointestinal adverse events, body composition changes and blood markers. 95% confidence intervals (CI) will be reported for the accuracy of DXA compared to computed tomography CT. The correlation between change of weight/body composition and tumor response will be investigated by logistic regression.

  Baseline to up to 6 months

Secondary Outcomes (3)

• Change in weight in patients with metastatic endocrine tumors during active intervention to control diarrhea and anorexia

  Baseline to up to 12 months

• Change in adipose tissue in patients with metastatic endocrine tumors during active intervention to control diarrhea and anorexia

  Baseline to up to 12 months

• Change in skeletal muscle in patients with metastatic endocrine tumors during active intervention to control diarrhea and anorexia

  Baseline to up to 12 months

Other Outcomes (2)

• Tumor response

  Up to 12 months

• Quality of life change

  Baseline to up to 12 months

Study Arms (1)

Cabozantinib or Lenvatinib

EXPERIMENTAL

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.

Procedure: Computed Tomography; Procedure: Dual X-ray Absorptiometry; Procedure: Physical Examination; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Cabozantinib; Drug: Lenvatinib

Interventions

Computed Tomography PROCEDURE

Correlative studies

Also known as: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography

Cabozantinib or Lenvatinib

Dual X-ray Absorptiometry PROCEDURE

Correlative studies

Also known as: BMD scan, bone mineral density scan, DEXA, DEXA Scan, dual energy x-ray absorptiometric scan, Dual Energy X-ray Absorptiometry, Dual X-Ray Absorptometry, DXA, DXA SCAN

Cabozantinib or Lenvatinib

Physical Examination PROCEDURE

Correlative studies

Also known as: assessment, Physical, Physical Assessment, PHYSICAL EXAM

Cabozantinib or Lenvatinib

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Cabozantinib or Lenvatinib

Questionnaire Administration OTHER

Ancillary studies

Cabozantinib or Lenvatinib

Cabozantinib DRUG

Also known as: XL-184, XL184

Cabozantinib or Lenvatinib

Lenvatinib DRUG

Also known as: E7080, Lenvima

Cabozantinib or Lenvatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Paraganglioma, Extra-Adrenal; Carcinoma, Medullary

Interventions

Absorptiometry, Photon; Restraint, Physical; cabozantinib; lenvatinib

Condition Hierarchy (Ancestors)

Paraganglioma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Carcinoma, Neuroendocrine; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Behavior Control; Therapeutics; Immobilization

Study Officials

• Naifa L Busaidy

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: October 30, 2015
• Study Start: November 16, 2015
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

US (1)