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Study of Muscle Energy Metabolism in RCC Patients Treated With Sunitinib

2 juli 2019 bijgewerkt door: AHS Cancer Control Alberta

Evaluation of Technetium-99m Sestamibi to Determine Muscle Energy Metabolism in RCC (Renal Cell Cancer) Patients Treated With Sunitinib

Sunitinib is a chemotherapy approved by the FDA as a standard of care treatment for renal cell carcinoma (RCC). Fatigue is a very common side effect of sunitinib that frequently causes dose reductions. The cause of this fatigue remains unclear. This study will use a special type of scan to study sunitinib-induced fatigue in relation to exercise.

Studie Overzicht

Toestand

Ingetrokken

Gedetailleerde beschrijving

Sunitinib, a type of tyrosine kinase inhibitor (TKI) has been approved by the FDA as a standard of care treatment for renal cell carcinoma (RCC). Fatigue is a very common side effect of sunitinib that frequently causes dose reductions. The cause of this fatigue remains unclear. It has been shown that TKIs disrupt growth factor pathways in muscles leading to muscle shrinkage. If sunitinib associated fatigue is due to altered muscle physiology at a molecular level, there will be observable changes in the uptake of 99mTc-sestamibi in scintigraphy scans. The study objective is to determine if sunitinib-induced fatigue as determined by VO2 and QOL fatigue related questionnaire responses are correlated to molecular changes in the muscles as evidenced by 99mTc-sestamibi uptake.

Studietype

Observationeel

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Men and women aged 18 years of age or older with a confirmed diagnosis of renal cell carcinoma. Participants will receive standard of care treatment with sunitinib. Participants must be willing to undergo exercise testing and diagnostic imaging with technitium 99m-sestamibi

Beschrijving

Inclusion Criteria:

  1. Signed informed consent before any study procedures completed
  2. Patients must have histologically or cytologically confirmed RCC.
  3. Four weeks must have elapsed since prior chemotherapy, hormonal therapy, targeted therapy or radiation therapy. There is no restriction on the amount of bone marrow previously radiated.
  4. Recovery to baseline or, at most, grade 1 of all drug-related toxicities due to prior chemotherapy, radiation, hormonal therapy, or molecular targeted therapy, expect for alopecia.
  5. Male / female subject ≥ 18 years of age
  6. Eastern Cooperative Oncology Group (ECOG) Performance Status of <2 (Karnofsky >70%)
  7. Life expectancy of at least 12 weeks
  8. Normal organ and marrow function as defined by :

    • absolute neutrophil count (ANC) > 1500/mcL
    • hemoglobin (Hb) > 90 g/L
    • platelet count ≥ 1000.000/mcL,
    • total bilirubin ≤ 1.5 x the upper limit of normal range (ULN)
    • alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN (<5 x ULN presence of liver metastases)
    • creatinine < 1.5 x institutional ULN
  9. Cardiac ejection fraction by MUGA scan or echocardiogram must be >50% for patients at baseline.
  10. Ability to understand the purpose of the study and the willingness to sign a written informed consent document
  11. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment. Standard Nuclear Medicine department pregnancy screening will be conducted prior to each 99mTc-sestamibi scan. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. The investigator is requested to advise the patient how to achieve an adequate contraception.
  12. Patients must give written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.

Exclusion Criteria:

  1. Patients who have had chemotherapy, hormonal therapy, molecular targeted therapy, or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  2. Patients may not be receiving any other investigational agents, chemotherapy, immunotherapy, radiotherapy, or molecular targeted agents.
  3. Prior treatment with a drug with known anti-angiogenic properties, including other tyrosine kinase inhibitors to VEGFR
  4. Any psychological, familial, sociological, or geographical conditions that do not permit medical follow-up and compliance with the study protocol.
  5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, HIV, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  6. Patients that are on therapeutic dose of coumadin or an INR of 1.5 c ULN. Patients that are on low dose coumadin (2mg or less for patency of the central venous catheter) or therapeutic dose of low molecular weight heparin will be allowed.
  7. Patients who cannot swallow
  8. Patients who are breast-feeding.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
99mTc-sestamibi uptake in muscle cells
Tijdsspanne: 12 weeks from start of treatment
12 weeks from start of treatment
99mTc-sestamibi uptake in muscle cells
Tijdsspanne: 24 weeks from start of treatment
24 weeks from start of treatment
99mTc-sestamibi uptake in muscle cells
Tijdsspanne: 36 weeks from start of treatment
36 weeks from start of treatment

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Incidence of sunitinib related fatigue
Tijdsspanne: 36 weeks after the start of sunitinib treatment
36 weeks after the start of sunitinib treatment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Michael Sawyer, MD, Alberta Health Services

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juni 2015

Primaire voltooiing (Werkelijk)

18 maart 2019

Studie voltooiing (Werkelijk)

18 maart 2019

Studieregistratiedata

Eerst ingediend

21 april 2015

Eerst ingediend dat voldeed aan de QC-criteria

23 april 2015

Eerst geplaatst (Schatting)

28 april 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 juli 2019

Laatste update ingediend die voldeed aan QC-criteria

2 juli 2019

Laatst geverifieerd

1 juli 2019

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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