Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02592356
Other study ID # 2014-0864
Secondary ID NCI-2015-0205820
Status Completed
Phase N/A
First received
Last updated
Start date November 16, 2015
Est. completion date March 1, 2024

Study information

Verified date March 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Baseline Visit If you agree to take part in this study, you will have the following tests and procedures at a baseline visit within 10 days after starting either cabozantinib or lenvatinib: Your height, weight, waist, and hips will be measured. You will have basic tests of your physical strength and balance. Your hand grip strength will be measured, you will be asked to rise from a chair without using your arms to push off, and you will complete a 6-minute walk test. You will have a full-body dual-energy x-ray absorptiometry (DXA) scan to measure the amount of fat and muscle in your body. Images from a standard computed tomography (CT) scan will also be collected and reviewed for this purpose. If you are scheduled only for a chest CT scan as part of your regular care, your abdomen will also be scanned at the same time for research purposes. You will meet with a dietician to talk about your current and past eating habits. You will fill out questionnaires about any pain or other symptoms you may have had; about any gastrointestinal (GI) side effects you may be having before you start chemotherapy; about the amount of physical exercise and activity you get; and about your food intake over the last 24 hours. Together the questionnaires should take about 20-25 minutes to complete. You will be receiving cabozantinib or lenvatinib as part of your standard of care. Study Visits After the baseline visit, you will have study visits on the following schedule. Some of these visits will be at the same time as your scheduled clinic visits with your regular doctor. However, some assessments will be done in between clinic visits online or by phone. Month 1 and 2: One (1) time every 2 weeks (+/- 1 week) during Months 1 and 2, you will fill out 3 questionnaires at home: You will be asked about any gastrointestinal (GI) and other side effects you may be having. This will be done by phone and should take about 5-10 minutes. You will fill out an online questionnaire at home about your eating habits over the last 24 hours. If you do not have internet access, you will complete the questionnaire over the phone with a member of the study staff. This should take about 10 minutes. You will complete a questionnaire about any symptoms you may be having online or by phone. This should take about 5-8 minutes. At Months 3, 6, and 12 (± 4 weeks) you will come to the clinic: Your height, weight, waist, and hips will be measured. You will have the same tests of your physical strength and balance that you had at the baseline visit. You will complete the same questionnaires you completed at the baseline visit. These will be done on paper or on a computer or tablet. You will have a DXA scan to measure the amount of fat and muscle in your body. If you are having certain GI side effects (such as diarrhea, nausea, vomiting, mouth sores, and so on), the study doctor will talk with you about receiving standard drugs to help with those side effects. You may ask the study staff for information about how the drugs are given and their risks. You may also meet with a dietician, who may recommend ways to help improve some side effects. Between clinic visits: Two (2) times per month (+/- 1 week) between Months 3 and 6, and once a month (+/- 1 week) between Months 6 and 12, you will complete 3 questionnaires at home about your food intake over the past 24 hours; any symptoms you may be having; and any GI or other side effects you may be having. The questionnaires may be completed online or by phone and together should take about 20 minutes. Length of Study Participation Your participation in this study will be over after the Month 12 visit


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date March 1, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Lenvatinib


Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Tumor response Summary descriptive statistics, including proportions, medians, means, 95% confidence intervals, and other simple statistics will be provided for demographics, tumor response rates and blood markers. 95% CI will be reported for the accuracy of DXA compared to CT. The correlation between change of weight/body composition and tumor response will be investigated by logistic regression. Up to 12 months
Other Quality of life change Summary descriptive statistics, including proportions, medians, means, 95% confidence intervals, and other simple statistics will be provided for demographics, tumor response rates and blood markers. 95% CI will be reported for the accuracy of DXA compared to CT. The correlation between change of weight/body composition and tumor response will be investigated by logistic regression. Baseline to up to 12 months
Primary 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 Change in weight in patients with metastatic endocrine tumors during active intervention to control diarrhea and anorexia Summary descriptive statistics, including proportions, medians, means, 95% confidence intervals, and other simple statistics will be provided for demographics, body composition changes and blood markers. 95% CI will be reported for the accuracy of DXA compared to CT. The correlation between change of weight/body composition and tumor response will be investigated by logistic regression. Baseline to up to 12 months
Secondary Change in adipose tissue in patients with metastatic endocrine tumors during active intervention to control diarrhea and anorexia Summary descriptive statistics, including proportions, medians, means, 95% confidence intervals, and other simple statistics will be provided for demographics, body composition changes and blood markers. 95% CI will be reported for the accuracy of DXA compared to CT. The correlation between change of weight/body composition and tumor response will be investigated by logistic regression. Baseline to up to 12 months
Secondary Change in skeletal muscle in patients with metastatic endocrine tumors during active intervention to control diarrhea and anorexia Summary descriptive statistics, including proportions, medians, means, 95% confidence intervals, and other simple statistics will be provided for demographics, body composition changes and blood markers. 95% CI will be reported for the accuracy of DXA compared to CT. The correlation between change of weight/body composition and tumor response will be investigated by logistic regression. Baseline to up to 12 months
See also
  Status Clinical Trial Phase
Completed NCT01204476 - Cixutumumab, Everolimus, and Octreotide Acetate in Treating Patients With Advanced Low to Intermediate Grade Neuroendocrine Carcinoma Phase 1
Completed NCT00028496 - Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer Phase 1
Completed NCT01709435 - Cabozantinib S-Malate in Treating Younger Patients With Recurrent or Refractory Solid Tumors Phase 1
Active, not recruiting NCT02293954 - Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer N/A
Active, not recruiting NCT02867592 - Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors Phase 2
Completed NCT01155258 - Temsirolimus and Vinorelbine Ditartrate in Treating Patients With Unresectable or Metastatic Solid Tumors Phase 1
Completed NCT00519896 - Sunitinib Malate in Treating Patients With Iodine-Refractory Recurrent or Metastatic Thyroid Cancer Phase 2
Recruiting NCT04759911 - Selpercatinib Before Surgery for the Treatment of RET-Altered Thyroid Cancer Phase 2
Completed NCT00134043 - Suberoylanilide Hydroxamic Acid in Treating Patients With Metastatic and/or Locally Advanced or Locally Recurrent Thyroid Cancer Phase 2
Completed NCT00118248 - Tanespimycin in Treating Patients With Inoperable Locoregionally Advanced or Metastatic Thyroid Cancer Phase 2
Completed NCT00655655 - Everolimus and Vatalanib in Treating Patients With Advanced Solid Tumors Phase 1
Completed NCT00068497 - Gefitinib in Treating Patients With Metastatic or Unresectable Head and Neck Cancer or Non-Small Cell Lung Cancer N/A
Completed NCT00004074 - Interleukin-12 and Trastuzumab in Treating Patients With Cancer That Has High Levels of HER2/Neu Phase 1
Recruiting NCT03892993 - Patient Decision Aid in Supporting Decision-Making About When to Start or Stop New Drugs, Join Clinical Trials, or Continue Active Surveillance in Patients With Medullary Thyroid Cancer and Their Caregivers N/A