Medical OncologyNCT05359848
A Pilot, Feasibility Study of Intermittent Caloric Restriction Plus Plant-based Diet in Cancer Patients Receiving Chemotherapy
A study testing Diet in people with Medical Oncology and Integrative Oncology, run by State University of New York at Buffalo at 2 sites in United States.
Trial summary
Caloric restriction may alter the response to chemotherapy induced stress response and enhance its antitumor effect. This study intends to use an intermitted caloric restriction protocol with alternate days before the chemotherapy administration to enhance the cytotoxic effect generated by standard treatment of cancer. 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
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Apr 2022to 1 Jun 2027
- 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, cancer patients who are eligible to receive cytotoxic chemotherapy.
- 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
Show all 12Show fewer
- 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)
- 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/MRI 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 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
- Recruiting
University at Buffalo / Great Lakes Cancer Care
Buffalo, New York, 14206
Ashlee Lang, MPH, 716-860-0267, alang@kaleidahealth.org
Kyle Pasquariello, MA, 716-529-6470, kpasquariello@gppconline.com
About this study
Official title: A Pilot, Feasibility Study of Intermittent Caloric Restriction Plus Plant-based Protein Diet in Cancer Patients Receiving Chemotherapy
Caloric restriction may alter the response to chemotherapy induced stress response and enhance its antitumor effect. This study intends to use an intermitted caloric restriction protocol with alternate days before the chemotherapy administration to enhance the cytotoxic effect generated by standard treatment of cancer.
Read the detailed description
This pilot trial will provide preliminary evidence that 1) intermittent caloric restriction and a plant-based diet is feasible in cancer patients; 2) intermittent caloric restriction and a plant-based diet can be safely combined with standard chemotherapy; and 3) intermittent caloric restriction and a plant-based diet may reduce the side effects but increase the antitumor effects of standard chemotherapy.
- Being tested
- Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Using dietary interventions as an adjuvant tool may represent an effective step toward advancing the treatment options of cancer. Dietary modifications can impact the growth and proliferation of tumors via multiple mechanisms
What is being measured
The primary outcome is the main question the study is designed to answer.
The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy
enrollment rate
Measured: 12 Months
The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy
drop-out rate
Measured: 12 Months
The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy
compliance with diet measured by self-reports
Measured: 12 Months
Secondary outcomes (3)
To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction
objective response rate (partial + complete response)
Measured: 12 Months
To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction
progression-free survival (PFS)
Measured: 12 Months
To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction
overall survival (OS)
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start15 Apr 2022
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jun 2027 (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
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with cancer where SOC is represented by chemotherapy will be eligible for the study. After informed consent, eligible patients will be scheduled to the chemotherapy. Each cycle will be every 14, 21 or 28 days depending on the regimen. The diet intervention will commence 1 week prior to the first infusion (i.e. on Day -5 for regimens every 21-28 days, on Day-3 for regimens every 14 days) and will continue until the end of cycle 4 or 6 depending on the regimen in the neoadjuvant or adjuvant setting. For metastatic disease the dietary intervention will last until cycle 6 and not beyond
- 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
- NCT05359848
- Sponsor's protocol ID
- STUDY00005648
- Status last verified
- Feb 2026
- First submitted
- 25 Apr 2022
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Feasibility Study of Intermittent Caloric Restriction Plus Plant-based Protein Diet in Cancer Patients Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT05359848
- Acronym / sponsor ID
- STUDY00005648
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 4 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.
Caloric restriction may alter the response to chemotherapy induced stress response and enhance its antitumor effect. This study intends to use an intermitted caloric restriction protocol with alternate days before the chemotherapy administration to enhance the cytotoxic effect generated by standard treatment of cancer.
Detailed description
This pilot trial will provide preliminary evidence that 1) intermittent caloric restriction and a plant-based diet is feasible in cancer patients; 2) intermittent caloric restriction and a plant-based diet can be safely combined with standard chemotherapy; and 3) intermittent caloric restriction and a plant-based diet may reduce the side effects but increase the antitumor effects of standard chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Patients with cancer where SOC is represented by chemotherapy will be eligible for the study. After informed consent, eligible patients will be scheduled to the chemotherapy. Each cycle will be every 14, 21 or 28 days depending on the regimen. The diet intervention will commence 1 week prior to the first infusion (i.e. on Day -5 for regimens every 21-28 days, on Day-3 for regimens every 14 days) and will continue until the end of cycle 4 or 6 depending on the regimen in the neoadjuvant or adjuvant setting. For metastatic disease the dietary intervention will last until cycle 6 and not beyond
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- • Histologically documented, cancer patients who are eligible to receive cytotoxic chemotherapy.
Key exclusion criteria (7 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 |
|---|---|---|
| DietUsing dietary interventions as an adjuvant tool may represent an effective step toward advancing the treatment options of cancer. Dietary modifications can impact the growth and proliferation of tumors via multiple mechanisms | Other | – |
Primary outcome
The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy
Time frame: 12 Months
enrollment rate
The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy
Time frame: 12 Months
drop-out rate
The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy
Time frame: 12 Months
compliance with diet measured by self-reports
3 secondary outcomes
To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction
Time frame: 12 Months
To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction
Time frame: 12 Months
To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction
Time frame: 12 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 20 Feb 2026.
- Individual participant dataSharing planned: 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
University at Buffalo / Great Lakes Cancer Care
Buffalo, United States
2 sites 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 2 sites 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 12 inclusion and 7 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 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy (time frame: 12 Months). The study lists 3 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 20 Feb 2026.