A Pilot and Feasibility Study of a Dietary Intervention With Low-protein Meals in Cancer Patients Receiving Immunotherapies
Dietary changes may boost cancer immunotherapy effectiveness
Plain English Summary
A Pilot and Feasibility Study of a Dietary Intervention With Low-protein Meals in Cancer Patients Receiving Immunotherapies is a Not Applicable clinical trial sponsored by State University of New York at Buffalo studying Medical Oncology, Integrative Oncology, Medical Nutrition Therapy. This study tests if a low-protein diet can improve how well immunotherapy works for cancer patients. It is for adults with solid tumors who are receiving or will receive immunotherapy drugs. Participants will follow either a standard diet or a special low-protein diet for 4 months. Standard cancer treatments and other dietary approaches are current alternatives. The trial aims to enroll 30 participants.
Official Summary
The main idea of this study is that a low protein diet may alter the environment surrounding the tumor, enhancing the body's immune response leading to greater anticancer effects of treatment. This study intends to use a low-protein diet as a tool to enhance the immune response generated by immune check point inhibitor treatments.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older with solid tumors that can be treated with immunotherapy. Patients must have advanced cancer and a life expectancy of at least 6 months. Good blood counts, kidney, and liver function are required. Individuals with certain other medical conditions or those taking specific medications (like high-dose steroids) may not be eligible. This trial is studying Medical Oncology, Integrative Oncology, Medical Nutrition Therapy, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary goal is to see if patients can stick to a low-protein diet, which is crucial for determining if this dietary approach can be safely combined with immunotherapy. The specific primary outcome measures are: To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies. (4 Months); To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies. (4 Months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial explores a dietary strategy to potentially enhance the effectiveness of existing cancer immunotherapies, addressing a need for supportive treatments that improve outcomes. This research targets Medical Oncology, Integrative Oncology, Medical Nutrition Therapy, where improved treatment options are needed.
Investor Insight
This pilot study investigates a novel, low-cost intervention to improve immunotherapy response, potentially expanding the market for supportive care in oncology.
Is This Trial Right for Me?
Ask your doctor if a low-protein diet is appropriate for you and how it might interact with your current treatment. You will be randomly assigned to either a standard diet or a diet with 10% protein for 4 months. The study will involve regular check-ups and monitoring of your health and treatment response. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 30 participants
Interventions
- OTHER: Diet — Control diet consisting of 20% protein, intervention diet consisting of 10% protein
Primary Outcomes
- To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies. (4 Months)
- To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies. (4 Months)
Secondary Outcomes
- To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies (4 Months)
- To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies (4 Months)
- To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies (4 Months)
- To assess the enrollment rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention (4 Months)
- To assess the Drop-out rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention (4 Months)
Full Eligibility Criteria
Inclusion Criteria:
* 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
* Life expectancy of at least 6 months
* Adults ≥ 18 years of age
* Adequate hematologic, renal, and liver function as evidenced by the following:
* White blood cell (WBC) ≥ 2,500 cells/μL
* Absolute neutrophil count (ANC) ≥ 1,000 cells/μL
* Platelet Count ≥ 100,000 cells/μL
* Hemoglobin (HgB) ≥ 9.0 g/dL
* Creatinine ≤ 2.0 mg/dL
* Total bilirubin ≤ 2 x upper limit of normal (ULN)
* Aspartate aminotransaminase (AST, SGOT) ≤ 2.5 x ULN
* Alanine aminotransaminase (ALT, SGPT) ≤ 2.5 x ULN
Exclusion Criteria:
* • Eastern Cooperative Oncology Group (ECOG) performance status 2 or higher
* Treatment with any of the following medications or interventions within 28 days of registration:
* Systemic corticosteroids; however, use of inhaled, intranasal, and topical steroids is acceptable.
* High dose calcitriol \[1,25(OH)2VitD\] (i.e., \> 7.0 μg/week)
* A requirement for systemic immunosuppressive therapy for any reason
* Any infection requiring parenteral antibiotic therapy or causing fever (temperature \> 100.5°F or 38.1°C) within 1 week prior to registration
* A known allergy, intolerance, or medical contraindication to receiving the contrast dye required for the protocol-specified CT imaging
* Any medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements or otherwise compromise the study's objectivesTrial Locations
- University at Buffalo / Great Lakes Cancer Care, Buffalo, New York, United States
Frequently Asked Questions
What is clinical trial NCT05356182?
NCT05356182 is a Not Applicable INTERVENTIONAL study titled "A Pilot and Feasibility Study of a Dietary Intervention With Low-protein Meals in Cancer Patients Receiving Immunotherapies." It is currently recruiting and is sponsored by State University of New York at Buffalo. The trial targets enrollment of 30 participants.
What conditions does NCT05356182 study?
This trial investigates treatments for Medical Oncology, Integrative Oncology, Medical Nutrition Therapy. The primary condition under study is Medical Oncology.
What treatments are being tested in NCT05356182?
The interventions being studied include: Diet (OTHER). Control diet consisting of 20% protein, intervention diet consisting of 10% protein
What does Not Applicable mean for NCT05356182?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT05356182?
This trial is currently "Recruiting." It started on 2022-05-04. The estimated completion date is 2028-02.
Who is sponsoring NCT05356182?
NCT05356182 is sponsored by State University of New York at Buffalo. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05356182?
The trial aims to enroll 30 participants. The trial is currently recruiting and accepting new participants.
How is NCT05356182 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT05356182?
The primary outcome measures are: To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies. (4 Months); To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies. (4 Months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05356182 being conducted?
This trial is being conducted at 1 site, including Buffalo, New York (United States).
Where can I find official information about NCT05356182?
The official record for NCT05356182 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05356182. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05356182 testing in simple terms?
This study tests if a low-protein diet can improve how well immunotherapy works for cancer patients. It is for adults with solid tumors who are receiving or will receive immunotherapy drugs.
Why is this trial significant?
This trial explores a dietary strategy to potentially enhance the effectiveness of existing cancer immunotherapies, addressing a need for supportive treatments that improve outcomes.
What are the potential risks of participating in NCT05356182?
Potential side effects of a low-protein diet can include fatigue, muscle loss, and nutrient deficiencies. Some patients may experience gastrointestinal issues or changes in their energy levels. The study requires regular blood tests and scans to monitor for any adverse effects. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05356182?
Ask your doctor if a low-protein diet is appropriate for you and how it might interact with your current treatment. You will be randomly assigned to either a standard diet or a diet with 10% protein for 4 months. The study will involve regular check-ups and monitoring of your health and treatment response. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05356182 signal from an investment perspective?
This pilot study investigates a novel, low-cost intervention to improve immunotherapy response, potentially expanding the market for supportive care in oncology. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will follow either a standard diet or a special low-protein diet for 4 months. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.