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Low-Protein Diet for Cancer
N/A
Recruiting
Research Sponsored by State University of New York at Buffalo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically documented solid tumor malignancies which is amenable for immunotherapy treatment with immune checkpoint inhibitors (i.e. PD1, PD-L1, CTLA inhibitors) as single agents or in combination.
Metastatic disease as evidenced by soft tissue and/or bony metastases on baseline bone scan and/or computed tomography (CT) scan of the chest, abdomen, and pelvis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
Study Summary
This trial will test whether a low protein diet can make immunotherapy more effective by changing the environment around the tumor.
Who is the study for?
Adults over 18 with solid tumor cancers suitable for immunotherapy can join this trial. They must have a certain level of white blood cells, platelets, and proper organ function. People on high-dose vitamin D, systemic steroids or immunosuppressants, those with poor physical status (ECOG >2), or infections needing antibiotics recently cannot participate.Check my eligibility
What is being tested?
The study is testing if eating low-protein meals can boost the body's immune response to cancer when patients are also receiving treatments known as immune checkpoint inhibitors. The goal is to see if diet changes can make these cancer treatments more effective.See study design
What are the potential side effects?
Since the intervention involves dietary changes rather than medication, side effects may include nutritional deficiencies or gastrointestinal discomfort due to alterations in usual eating habits.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is suitable for immunotherapy treatment.
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My scans show cancer has spread to my bones or soft tissues.
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My blood, kidney, and liver tests are within normal ranges.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies.
Secondary outcome measures
To assess the Drop-out rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention
To assess the enrollment rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention
To assess the safety and tolerability of the combination of immunotherapies and low-protein diet intervention
+2 moreTrial Design
2Treatment groups
Active Control
Group I: Low-Protein Diet ArmActive Control1 Intervention
intervention low-protein diet arm (10% protein content)
Group II: Control Diet ArmActive Control1 Intervention
control diet arm (~20% protein content)
Find a Location
Who is running the clinical trial?
State University of New York at BuffaloLead Sponsor
246 Previous Clinical Trials
49,458 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is suitable for immunotherapy treatment.My scans show cancer has spread to my bones or soft tissues.I am taking more than 7.0 μg of calcitriol per week.My blood, kidney, and liver tests are within normal ranges.I am 18 years old or older.I am not on systemic corticosteroids, but I may use inhaled, nasal, or topical steroids.I need medication to suppress my immune system.I haven't had a fever or needed IV antibiotics in the last week.You have an allergy or medical condition that prevents you from receiving the special dye needed for the CT scan.I haven't taken specific medications or undergone certain treatments in the last 28 days.I need assistance with daily activities due to my health condition.You are expected to live for at least 6 more months.
Research Study Groups:
This trial has the following groups:- Group 1: Low-Protein Diet Arm
- Group 2: Control Diet Arm
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum number of participants in this clinical research?
"Affirmative. The information on clinicaltrials.gov indicates that this trial is presently hunting for test subjects. It was initially posted on May 4th, 2022 and had its most recent refreshment on July 25th, 2022. This experiment involves the enrolment of 30 participants at 1 medical facility."
Answered by AI
Does this research initiative currently accept participants?
"Yes, the details found on clinicaltrials.gov demonstrate that this experiment is currently recruiting participants. This study was initially posted to the public domain on May 4th 2022 and most recently updated on July 25th of the same year. A total of 30 patients are required from a single site for participation in this trial."
Answered by AI
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