Spots Global Cancer Trial Database for Short-Term Fasting: Impact on Toxicity

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Trial Identification

Brief Title: Short-Term Fasting: Impact on Toxicity

Official Title: Short-Term Fasting Prior To Platinum-based Chemotherapy: Feasibility and Impact on Toxicity

Study ID: NCT00936364

Conditions

Fasting in Malignant Solid Tumors

Interventions

Short-term fasting

Modified fast

Fasting

Study Description

Brief Summary: 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.

Detailed Description: OBJECTIVES: I. To determine the safety and feasibility of short-term fasting prior to administration of combination chemotherapy with platinum in patients with advanced solid tumor malignancies. II. To evaluate the toxicity profile of platinum-based chemotherapy in subjects who eat normally compared to those who undertake short-term starvation. III. To investigate changes in plasma insulin, glucose, IGF1 and IGF binding protein (IGFBP) levels, and oxidative stress markers in subjects who undertake short-term fasting compared to controls. IV. To investigate whether changes in grp78 expression occur after fasting and after chemotherapy administration in human subjects. OUTLINE: STAGE I: Patients are assigned to 1 of 4 treatment groups. GROUP I: Patients fast for 24 hours on day-1. GROUP II: Patients fast for 48 hours on days -2 and -1. GROUP III: Patients fast for 72 hours on days -3, -2, and-1. GROUP IV: Patients undergo a modified 48-hour fast with minimal caloric intake on days -2 and -1. STAGE II: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients fast for 72 hours on days -2, and on day 1. ARM II: Patients proceed to chemotherapy without fasting. All patients receive gemcitabine hydrochloride intravenously (IV) on days 1 and 8 and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.