Differentiated Thyroid Gland CarcinomaNCT02592356
Effect of Cabozantinib S-Malate or Lenvatinib Mesylate on Weight and Body Composition in Patients With Metastatic Endocrine Cancer
A study testing Computed Tomography, Dual X-ray Absorptiometry and Physical Examination in people with Differentiated Thyroid Gland Carcinoma and Malignant Adrenal Gland Pheochromocytoma, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Differentiated Thyroid Gland Carcinoma, Malignant Adrenal Gland Pheochromocytoma, Malignant Paraganglioma
- What is being tested?
- Computed Tomography, Dual X-ray Absorptiometry and Physical Examination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2015to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Tyrosine Kinase Inhibitors on Body Composition in Endocrine Tumors -- A Pilot Study
The goal of this clinical research study is to learn about possible weight, muscle, and/or fat loss in patients receiving cabozantinib or lenvatinib.
Read the detailed 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
- Conditions
- Differentiated Thyroid Gland Carcinoma, Malignant Adrenal Gland Pheochromocytoma, Malignant Paraganglioma, Thyroid Gland Medullary Carcinoma
- Being tested
- Computed Tomography, Dual X-ray Absorptiometry, Physical Examination, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Paraganglioma, Extra-Adrenal, Carcinoma, Medullary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, computerized tomography
Correlative studies
Dual X-ray AbsorptiometryProcedure or surgery
Also called BMD scan, bone mineral density scan, DEXA, DEXA Scan
Correlative studies
Physical ExaminationProcedure or surgery
Also called assessment, Physical, Physical Assessment, PHYSICAL EXAM
Correlative studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
CabozantinibDrug
Also called XL-184, XL184
LenvatinibDrug
Also called E7080, Lenvima
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Computed Tomography; Procedure: Dual X-ray Absorptiometry; Procedure: Physical Examination; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Cabozantinib; Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline to up to 12 months
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.
Measured: Baseline to up to 12 months
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.
Measured: Baseline to up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study start16 Nov 2015
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Differentiated Thyroid Gland CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Naifa L Busaidy, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592356
- Sponsor's protocol ID
- 2014-0864
- Other IDs
- NCI-2015-02058, 2014-0864
- Status last verified
- Mar 2024
- First submitted
- 27 Oct 2015
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tyrosine Kinase Inhibitors on Body Composition in Endocrine Tumors -- A Pilot Study
- ClinicalTrials.gov ID
- NCT02592356
- Acronym / sponsor ID
- 2014-0864
- Conditions
- Differentiated Thyroid Gland Carcinoma, Malignant Adrenal Gland Pheochromocytoma, Malignant Paraganglioma, Thyroid Gland Medullary Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Nov 2015 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 30 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn about possible weight, muscle, and/or fat loss in patients receiving cabozantinib or lenvatinib.
Detailed 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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cabozantinib or Lenvatinib | Experimental | Procedure: Computed Tomography, Procedure: Dual X-ray Absorptiometry, Procedure: Physical Examination, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Drug: Cabozantinib, Drug: LenvatinibPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, computerized tomographyCorrelative studies | Procedure or surgery | Cabozantinib or Lenvatinib |
| Dual X-ray AbsorptiometryAlso: BMD scan, bone mineral density scan, DEXA, DEXA ScanCorrelative studies | Procedure or surgery | Cabozantinib or Lenvatinib |
| Physical ExaminationAlso: assessment, Physical, Physical Assessment, PHYSICAL EXAMCorrelative studies | Procedure or surgery | Cabozantinib or Lenvatinib |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Cabozantinib or Lenvatinib |
| Questionnaire AdministrationAncillary studies | Other | Cabozantinib or Lenvatinib |
| CabozantinibAlso: XL-184, XL184 | Drug | Cabozantinib or Lenvatinib |
| LenvatinibAlso: E7080, Lenvima | Drug | Cabozantinib or Lenvatinib |
Primary outcome
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
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.
3 secondary outcomes
Change in weight in patients with metastatic endocrine tumors during active intervention to control diarrhea and anorexia
Time frame: Baseline to up to 12 months
Change in adipose tissue in patients with metastatic endocrine tumors during active intervention to control diarrhea and anorexia
Time frame: Baseline to up to 12 months
Change in skeletal muscle in patients with metastatic endocrine tumors during active intervention to control diarrhea and anorexia
Time frame: Baseline to up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naifa L Busaidy principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computed Tomography, Dual X-ray Absorptiometry and Physical Examination in people with Differentiated Thyroid Gland Carcinoma and Malignant Adrenal Gland Pheochromocytoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.