NCT00936364|TerminatedDMC
Study Stopped
Insufficient accrual
Short-Term Fasting: Impact on Toxicity
Short-Term Fasting Prior To Platinum-based Chemotherapy: Feasibility and Impact on Toxicity
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Sponsor study identifier
interventional
47
1 country
1
Study Start
July 9, 2009
Actual (reported)Primary Completion
September 1, 2024
Actual (reported)Study Completion
May 23, 2025
Actual (reported)This partially randomized clinical trial studies short-term fasting in reducing side effects in patients receiving gemcitabine hydrochloride and cisplatin for advanced solid tumors. Short-term fasting before chemotherapy may reduce the side effects caused by chemotherapy. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 23, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 9, 2009
Actual (reported)July 9, 2009
Actual (reported)July 10, 2009
Actual (reported)September 1, 2024
Actual (reported)May 23, 2025
Actual (reported)Identification of the longest duration of fasting which is safe
Up to 5 years
Significant toxicity as assessed by CTCAE v3.0
Up to 5 years
Changes in plasma insulin, glucose, IGF1 and IGF binding protein (IGFBP) levels, and GRP78 expression in WBCs
Up to 2 courses
Changes in grp78 expression after fasting and after chemotherapy administration
After 2 courses
Patients fast for 24 hours on day -1
Patients fast for 48 hours on days -2 and -1
No calories will be consumed during periods of fasting. Good oral hydration will be encouraged. Water may be consumed, as well as non-caloric beverages (i.e. zero calorie soft drinks, black coffee or tea).
USC/Norris Comprehenseive Cancer Center
Los Angeles, California, 90033, United States
Dorff TB, Groshen S, Garcia A, Shah M, Tsao-Wei D, Pham H, Cheng CW, Brandhorst S, Cohen P, Wei M, Longo V, Quinn DI. Safety and feasibility of fasting in combination with platinum-based chemotherapy. BMC Cancer. 2016 Jun 10;16:360. doi: 10.1186/s12885-016-2370-6.
David I Quinn, MD
University of Southern California
47 participants (actual enrollment reported by the registry).
First Submitted
July 9, 2009
First Posted
July 10, 2009
Study Start
July 9, 2009
Actual (reported)The Meta-SHIFT Study: How Metabolic Shift Shapes Human Immunometabolism - a Fasting Trial
Patients fast for 72 hours on days -3, -2, and -1
Patients undergo a modified 48-hour fast with minimal caloric intake on day -2 and -1
Minimal caloric intake on days -2 and -1
Day -1
Days -2 and -1
Days -3, -2, and -1
48-hour fast with minimal caloric intake on days -2 and -1
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
September 1, 2024
Actual (reported)Study Completion
May 23, 2025
Actual (reported)Last Updated
June 2, 2025
Record last verified: 2025-05
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Source: ClinicalTrials.gov.
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