Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-01-22 @ 7:27 PM
Study NCT ID:
NCT02428335
Status:
WITHDRAWN
Last Update Posted:
2019-07-05
First Post:
2015-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Muscle Energy Metabolism in RCC Patients Treated With Sunitinib
Sponsor:
AHS Cancer Control Alberta
Organization:
Study Overview
Official Title:
Evaluation of Technetium-99m Sestamibi to Determine Muscle Energy Metabolism in RCC (Renal Cell Cancer) Patients Treated With Sunitinib
Status:
WITHDRAWN
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient financial resources to conduct research and complete trial.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: