Fasting for Cancer Side Effect Reduction

Recruiting in Palo Alto (17 mi)

Overseen by David I Quinn, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Southern California

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

David I Quinn, MD

Principal Investigator

University of Southern California

Eligibility Criteria

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.

Inclusion Criteria

I've had limited chemotherapy and none recently for my cancer stage.

You have a body mass index (BMI) above 18.5.

Premenopausal women must have a negative pregnancy test and must agree to use barrier contraception throughout the study period

Exclusion Criteria

I have not had any recent, unexplained weight loss that could be risky.

I do not have severe numbness or pain in my hands or feet.

I take medications that cannot be stopped or must be taken with food.

Treatment Details

Interventions

• Fasting (Other)
• Modified fast (Other)
• Short-term fasting (Other)

Trial Overview 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.

Participant Groups

Group I: Group IV (Stage I of study) Experimental Treatment 2 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 Treatment 2 Interventions

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

Group III: Group II (Stage I of study) Experimental Treatment 2 Interventions

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

Group IV: Group I (Stage I of study) Experimental Treatment 2 Interventions

Patients fast for 24 hours on day -1

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Dr. Samir A.

University of Southern California

Chief Executive Officer since 2024

PhD in Molecular Biology from the University of Southern California

Dr. Chung

University of Southern California

Chief Medical Officer since 2016

MD from UC San Diego