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Fasting + PD-1/PD-L1 Inhibitors for Skin Cancer
Study Summary
This trial is testing the effects of fasting before treatment with a PD-L1 or PD-1 inhibitor for skin cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I haven't had radiation or certain drug treatments in the last 4 weeks.I have been treated with drugs that target PD-1 or PD-L1.You had allergic reactions to drugs similar to the PD-1 or PD-L1 inhibitor.I have not had major surgery in the last 2 weeks or have recovered from any major complications.I have had 2 or fewer treatments for my cancer, not counting initial treatments.You have a sufficient number of a type of white blood cell called lymphocytes in your blood.I have fainted due to not eating or have a condition that makes fasting unsafe.I am fully active or can carry out light work.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I haven't taken high doses of steroids in the last 2 weeks.My kidney function is within the required range.I haven't needed drugs for an autoimmune disease in the last 2 years, except for hormone replacements.My skin cancer is advanced, can be measured for its size, and might have spread to other parts.My cancer is recommended to be treated with specific immune therapy drugs.Your total bilirubin level is not higher than 1.5 times the upper limit of normal at the institution.I haven't taken immune system drugs within the last 4 weeks.Your AST and ALT blood test results should not be more than three times the normal limit.I have had a solid organ or bone marrow transplant.I am not currently on any other cancer treatments or experimental drugs.I do not have diabetes or I had it but it's resolved and I'm not on medication.I take medications that cannot be stopped or must be taken with food.I do not have brain metastases.You are pregnant, nursing, or breastfeeding, as the treatment could harm the baby.You weigh enough for your height.Your platelet count must be at least 75,000 per microliter.Your absolute neutrophil count is at least 1,000 per microliter.Your hemoglobin level is at least 8.0 grams per deciliter.
- Group 1: Treatment (STF, PD-1/PD-L1 inhibitor)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Frequently Asked Questions
What potential risks could be associated with engaging in short-term fasting?
"The team at Power assigned a score of 1 to short-term fasting, due to its limited evidence of safety and efficacy in clinical trials."
How many people are being enrolled in this clinical trial?
"Indeed, according to the information on clinicaltrials.gov, this medical trial initiated recruitment on August 12th 2020 and is still actively seeking participants. 16 individuals need to be enrolled across 2 distinct sites."
What medical benefits are typically associated with Short-Term Fasting?
"Short-Term Fasting is most often utilized to treat cancerous neoplasms, but can also be employed for the management of other maladies like microsatellite instability high, unresectable melanoma, and squamous cell carcinoma."
Is this investigation a pioneering endeavor?
"According to the most up-to-date information, 2433 Short-Term Fasting trials are taking place in 81 countries and 4285 cities. The initial study was conducted by Hoffmann-La Roche back in 2008 with 720 participants; since then 835 other studies have been completed. This trial achieved Phase 2 drug approval status upon conclusion."
Are there still openings available to participate in this experiment?
"Indeed, according to clinicaltrials.gov this medical trial is in the process of recruitment and has been since August 12th 2020. The study was last updated on August 19th 2022 and requires 16 participants across 2 sites."
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