Medical OncologyNCT05356182
A Pilot and Feasibility Study of a Dietary Intervention With Low-protein Meals in Cancer Patients Receiving Immunotherapies
A study testing Diet in people with Medical Oncology and Integrative Oncology, run by State University of New York at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medical Oncology, Integrative Oncology, Medical Nutrition Therapy
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2022to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- • 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 objectives
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University at Buffalo / Great Lakes Cancer Care
Buffalo, New York, 14203
Ashlee Lang, MPH, 716-860-0267, alang@kaleidahealth.org
Kyle Pasquariello, MA, 716-529-6470, kpasquariello@gppconline.com
About this study
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.
Read the detailed description
This is a single center, randomized, open label study to assess the feasibility of a low-protein diet intervention in cancer patients who are receiving immunotherapies. Subjects will be randomized in a 1:1 ratio to either immunotherapy plus control diet arm (~20% protein content) or immunotherapy plus intervention low-protein diet arm (10% protein content).
- Being tested
- Diet
- Keywords
- Oncology, Nutrition, Immunotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Control diet consisting of 20% protein, intervention diet consisting of 10% protein
| Study group | Role | What they receive |
|---|---|---|
| Control Diet Arm | Active comparator | control diet arm (~20% protein content) Receives: Other: Diet |
| Low-Protein Diet Arm | Active comparator | intervention low-protein diet arm (10% protein content) Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies.
Change in blood urea nitrogen (BUN) from baseline to post-intervention (following 3 cycles of treatment) will be measured to assess adherence of following the diet intervention.
Measured: 4 Months
To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies.
Change in urine urea nitrogen (UUN) from baseline to post-intervention (following 3 cycles of treatment) will be measured to assess adherence of following the diet intervention.
Measured: 4 Months
Secondary outcomes (9)
To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies
Includes isolation and characterization of antigen specific T cell clones
Measured: 4 Months
To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies
Includes evaluation of antigen specific T cell populations by spectratyping T cell receptor expression
Measured: 4 Months
To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies
Includes characterization of antigen response by cytokine and chemokine production
Measured: 4 Months
To assess the enrollment rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention
Enrollment rate
Measured: 4 Months
To assess the Drop-out rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention
Drop-out rate
Measured: 4 Months
To assess the safety and tolerability of the combination of immunotherapies and low-protein diet intervention
Compliance with diet measured by self-report of patient
Measured: 4 Months
To obtain preliminary evidence of clinical efficacy of immunotherapies and low-protein diet compared to immunotherapies and control-diet using the RECIST v1.1 criteria
Objective Response Rate (ORR)
Measured: 4 Months
To obtain preliminary evidence of clinical efficacy of immunotherapies and low-protein diet compared to immunotherapies and control-diet using the RECIST v1.1 criteria
Progression-Free Survival (PFS)
Measured: 4 Months
To obtain preliminary evidence of clinical efficacy of immunotherapies and low-protein diet compared to immunotherapies and control-diet using the RECIST v1.1 criteria
Overall Survival(OS)
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start4 May 2022
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical OncologyStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Pili, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356182
- Sponsor's protocol ID
- STUDY00005755
- Status last verified
- Mar 2026
- First submitted
- 1 Apr 2022
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot and Feasibility Study of a Dietary Intervention With Low-protein Meals in Cancer Patients Receiving Immunotherapies
- ClinicalTrials.gov ID
- NCT05356182
- Acronym / sponsor ID
- STUDY00005755
- Keywords
- Oncology, Nutrition, Immunotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 4 May 2022 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single center, randomized, open label study to assess the feasibility of a low-protein diet intervention in cancer patients who are receiving immunotherapies. Subjects will be randomized in a 1:1 ratio to either immunotherapy plus control diet arm (~20% protein content) or immunotherapy plus intervention low-protein diet arm (10% protein content).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Diet Arm | Active comparator | Other: Dietcontrol diet arm (~20% protein content) |
| Low-Protein Diet Arm | Active comparator | Other: Dietintervention low-protein diet arm (10% protein content) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (8 listed)
- • Eastern Cooperative Oncology Group (ECOG) performance status 2 or higher
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietControl diet consisting of 20% protein, intervention diet consisting of 10% protein | Other | Control Diet Arm, Low-Protein Diet Arm |
Primary outcome
To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies.
Time frame: 4 Months
Change in blood urea nitrogen (BUN) from baseline to post-intervention (following 3 cycles of treatment) will be measured to assess adherence of following the diet intervention.
To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies.
Time frame: 4 Months
Change in urine urea nitrogen (UUN) from baseline to post-intervention (following 3 cycles of treatment) will be measured to assess adherence of following the diet intervention.
9 secondary outcomes
To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies
Time frame: 4 Months
To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies
Time frame: 4 Months
To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies
Time frame: 4 Months
To assess the enrollment rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention
Time frame: 4 Months
To assess the Drop-out rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention
Time frame: 4 Months
To assess the safety and tolerability of the combination of immunotherapies and low-protein diet intervention
Time frame: 4 Months
To obtain preliminary evidence of clinical efficacy of immunotherapies and low-protein diet compared to immunotherapies and control-diet using the RECIST v1.1 criteria
Time frame: 4 Months
To obtain preliminary evidence of clinical efficacy of immunotherapies and low-protein diet compared to immunotherapies and control-diet using the RECIST v1.1 criteria
Time frame: 4 Months
To obtain preliminary evidence of clinical efficacy of immunotherapies and low-protein diet compared to immunotherapies and control-diet using the RECIST v1.1 criteria
Time frame: 4 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: Undecided. undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University at Buffalo / Great Lakes Cancer Care
Buffalo, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with Medical Oncology and Integrative Oncology, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies. (time frame: 4 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.