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Short-Term Fasting: Impact on Toxicity

NCT00936364 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2025-06-02

No results posted yet for this study

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.

Conditions

  • Fasting in Malignant Solid Tumors

Interventions

OTHER

Short-term fasting

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).

OTHER

Modified fast

Minimal caloric intake on days -2 and -1

OTHER

Fasting

Day -1

OTHER

Fasting

Days -2 and -1

OTHER

Fasting

Days -3, -2, and -1

OTHER

Fasting

48-hour fast with minimal caloric intake on days -2 and -1

Sponsors & Collaborators

  • University of Southern California

    lead OTHER

Principal Investigators

  • David I Quinn, MD · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-09
Primary Completion
2024-09-01
Completion
2025-05-23

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00936364 on ClinicalTrials.gov