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

Status: Terminated
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
USC/Norris Comprehenseive Cancer Center
Los Angeles
Time Frame
Start Date: 2009-07-09
Completion Date: 2025-05-23
Participants
Target number of participants: 47
Treatments
Experimental: Group I (Stage I of study)
Patients fast for 24 hours on day -1
Experimental: Group II (Stage I of study)
Patients fast for 48 hours on days -2 and -1
Experimental: Group III (Stage I of study)
Patients fast for 72 hours on days -3, -2, and -1
Experimental: Group IV (Stage I of study)
Patients undergo a modified 48-hour fast with minimal caloric intake on day -2 and -1
Sponsors
Leads: University of Southern California

This content was sourced from clinicaltrials.gov

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