Short-Term Fasting: Impact on Toxicity

May 27, 2025 updated by: University of Southern California

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • USC/Norris Comprehenseive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I (Stage I of study)
Patients fast for 24 hours on day -1
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 Names:
  • fasting
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
Experimental: Group II (Stage I of study)
Patients fast for 48 hours on days -2 and -1
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 Names:
  • fasting
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
Experimental: Group III (Stage I of study)
Patients fast for 72 hours on days -3, -2, and -1
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 Names:
  • fasting
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
Experimental: Group IV (Stage I of study)
Patients undergo a modified 48-hour fast with minimal caloric intake on day -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
Other: Modified fast
Minimal caloric intake on days -2 and -1
Other Names:
  • fasting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identification of the longest duration of fasting which is safe
Time Frame: Up to 5 years
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Significant toxicity as assessed by CTCAE v3.0
Time Frame: Up to 5 years
Up to 5 years
Changes in plasma insulin, glucose, IGF1 and IGF binding protein (IGFBP) levels, and GRP78 expression in WBCs
Time Frame: Up to 2 courses
Up to 2 courses
Changes in grp78 expression after fasting and after chemotherapy administration
Time Frame: After 2 courses
After 2 courses

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Investigators

  • Principal Investigator: David I Quinn, MD, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2009

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

May 23, 2025

Study Registration Dates

First Submitted

July 9, 2009

First Submitted That Met QC Criteria

July 9, 2009

First Posted (Estimated)

July 10, 2009

Study Record Updates

Last Update Posted (Actual)

June 2, 2025

Last Update Submitted That Met QC Criteria

May 27, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 0S-08-9

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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