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Fasting for Cancer Side Effect Reduction

N/A

Waitlist Available

Led By David I Quinn, MD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18 years

Histologically confirmed malignancy for which platinum-based chemotherapy on a 21 day cycle or 14 day cycle is being recommended

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying if fasting may reduce side effects from gemcitabine hydrochloride and cisplatin in patients with solid tumors.

Who is the study for?

This trial is for adults over 18 with advanced solid tumors who are recommended platinum-based chemotherapy. They must have adequate kidney function, an ECOG performance status of 0-1, and a BMI above 18.5. Women must not be pregnant and agree to use contraception. Exclusions include diabetes, recent unexplained weight loss, severe neuropathy or heart disease, certain medications that can't be stopped during fasting, or health issues making fasting dangerous.Check my eligibility

What is being tested?

The study examines if short-term fasting before receiving gemcitabine hydrochloride and cisplatin reduces side effects in patients with advanced tumors. Participants will either fast or follow a modified fast prior to chemotherapy to see if it impacts the treatment's toxicity.See study design

What are the potential side effects?

Potential side effects from the chemotherapy drugs may include nausea, vomiting, low blood cell counts leading to increased infection risk or bleeding problems, kidney damage, and nerve issues like numbness or tingling sensations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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My cancer is confirmed and I am recommended to have platinum-based chemotherapy every 2 or 3 weeks.

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My cancer is newly diagnosed and I am planning to undergo chemotherapy.

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My kidney function is within normal limits.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Identification of the longest duration of fasting which is safe

Secondary outcome measures

Changes in grp78 expression after fasting and after chemotherapy administration

Changes in plasma insulin, glucose, IGF1 and IGF binding protein (IGFBP) levels, and GRP78 expression in WBCs

Significant toxicity as assessed by CTCAE v3.0

Trial Design

4Treatment groups

Experimental Treatment

Group I: Group IV (Stage I of study)Experimental Treatment2 Interventions

Patients undergo a modified 48-hour fast with minimal caloric intake on day -2 and -1

Group II: Group III (Stage I of study)Experimental Treatment2 Interventions

Patients fast for 72 hours on days -3, -2, and -1

Group III: Group II (Stage I of study)Experimental Treatment2 Interventions

Patients fast for 48 hours on days -2 and -1

Group IV: Group I (Stage I of study)Experimental Treatment2 Interventions

Patients fast for 24 hours on day -1

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor

905 Previous Clinical Trials

1,596,208 Total Patients Enrolled

1 Trials studying Fasting

24 Patients Enrolled for Fasting

David I Quinn, MDPrincipal InvestigatorUniversity of Southern California

3 Previous Clinical Trials

162 Total Patients Enrolled

Media Library

Short-term fasting Clinical Trial Eligibility Overview. Trial Name: NCT00936364 — N/A

Fasting Research Study Groups: Group IV (Stage I of study), Group I (Stage I of study), Group III (Stage I of study), Group II (Stage I of study)

Fasting Clinical Trial 2023: Short-term fasting Highlights & Side Effects. Trial Name: NCT00936364 — N/A

Short-term fasting 2023 Treatment Timeline for Medical Study. Trial Name: NCT00936364 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently opportunities for individuals to become involved in this trial?

"Reported on clinicaltrials.gov, the trial is no longer enrolling patients - it was first posted in July 2009 and has been edited as recently as November 2022. Fortunately, there are other studies that are actively looking for volunteers at this time."

Answered by AI

Recent research and studies

BMC CancerJournal

Safety and Feasibility of Fasting in Combination with Platinum-based Chemotherapy

Dorff, Tanya B., Susan Groshen, Agustin Garcia, Manali Shah, Denice Tsao-Wei, Huyen Pham, Chia-Wei Cheng, et al.. 2016. “Safety and Feasibility of Fasting in Combination with Platinum-based Chemotherapy”. BMC Cancer. Springer Science and Business Media LLC. doi:10.1186/s12885-016-2370-6.

clinicaltrials.govStudy

Short-Term Fasting: Impact on Toxicity

2009. "Short-Term Fasting: Impact on Toxicity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00936364.

All > Toxicity > Paid Studies California