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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
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have severe numbness or pain in my hands or feet.
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I have a history of serious heart disease, but my heart function has been checked if needed.
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I have diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
946 Previous Clinical Trials
1,604,549 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had any recent, unexplained weight loss that could be risky.I've had limited chemotherapy and none recently for my cancer stage.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.You have a body mass index (BMI) above 18.5.I finished my radiotherapy at least 2 weeks ago.My cancer can be measured and hasn't been treated with surgery or radiation yet.I am older than 18 years.My cancer is confirmed and I am recommended to have platinum-based chemotherapy every 2 or 3 weeks.My cancer is newly diagnosed and I am planning to undergo chemotherapy.My kidney function is within normal limits.I have a history of serious heart disease, but my heart function has been checked if needed.I have fainted from not eating enough or have a health condition that makes fasting unsafe.I have diabetes.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: Group IV (Stage I of study)
- Group 2: Group I (Stage I of study)
- Group 3: Group III (Stage I of study)
- Group 4: Group II (Stage I of study)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.