Status:
TERMINATED
Short-Term Fasting: Impact on Toxicity
Lead Sponsor:
University of Southern California
Conditions:
Fasting in Malignant Solid Tumors
Eligibility:
All Genders
19+ years
Phase:
NA
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...
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....
Eligibility Criteria
Inclusion
- Age \> 18 years
- Histologically confirmed malignancy for which platinum-based chemotherapy on a 21 day cycle or 14 day cycle is being recommended.
- Disease state:
- Stage I of the trial: newly diagnosed disease for which neoadjuvant or adjuvant chemotherapy is planned in the curative setting, or metastatic disease.
- Stage II of the trial: Measurable disease by RECIST criteria must be present for all subjects in the randomized component of the trial- if surgery or radiation is planned, the target lesions may not be so treated until after the assessment of the effect of chemotherapy.
- Prior chemotherapy
- Stage I: subjects may have already received no more than 2 cycle of platinum-based chemotherapy, but should not have received other prior chemotherapy regimens with the exception of patients with metastatic disease who received neoadjuvant or adjuvant chemotherapy and that chemotherapy was completed \> 6 months prior to enrollment.
- Stage II: subjects must have received no prior chemotherapy regimens for metastatic disease, and no more than 2 cycles of their current platinum chemotherapy regimen for metastatic disease. They may have received prior neoadjuvant or adjuvant chemotherapy, provided such therapy was completed \>6 months prior to enrollment.
- Prior Radiotherapy is allowed, provided at least 2 weeks have elapsed from completion of radiotherapy to initiation of protocol treatment.
- BMI \> 18.5
- ECOG performance status 0-1
- Adequate renal function (Creatinine \<1.25 ULIN or calculated creatinine clearance \> 50 ml/min)
- Premenopausal women must have a negative pregnancy test and must agree to use barrier contraception throughout the study period.
Exclusion
- Diabetes Mellitus
- Recent significant or unexplained weight loss that the investigator feels may pose an unacceptable risk for enrollment. Candidates who are overweight and have lost weight intentionally via diet or exercise should not be excluded.
- Peripheral Neuropathy \> grade 1
- History of significant cardiac disease, particularly uncompensated congestive heart failure NYHA grade 2 or more or LVEF \< 40% on any prior assessment. (Assessment of LVEF prior to therapy is not required in the absence of other clinical indicators of heart disease). Patients with a prior LVEF \<40% will require re-evaluation prior to study entry.
- Subjects on medications that may not be safely stopped during the fasting portion of the study, or which may not be safely consumed without food.
- A history of syncope with calorie restriction in the past or other medical comorbidity, which would make fasting potentially dangerous.
Key Trial Info
Start Date :
July 9 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2025
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00936364
Start Date
July 9 2009
End Date
May 23 2025
Last Update
June 2 2025
Active Locations (1)
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1
USC/Norris Comprehenseive Cancer Center
Los Angeles, California, United States, 90033