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Trial record 1 of 1 for:    Plant-based | Cancer | University at Buffalo | United States
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A Pilot, Feasibility Study of Intermittent Caloric Restriction Plus Plant-based Diet in Cancer Patients Receiving Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05359848
Recruitment Status : Recruiting
First Posted : May 4, 2022
Last Update Posted : July 26, 2022
Sponsor:
Information provided by (Responsible Party):
Roberto Pili, State University of New York at Buffalo

Brief 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.

Condition or disease Intervention/treatment Phase
Medical Oncology Integrative Oncology Medical Nutrition Therapy Other: Diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: A Pilot, Feasibility Study of Intermittent Caloric Restriction Plus Plant-based Protein Diet in Cancer Patients Receiving Chemotherapy
Actual Study Start Date : April 15, 2022
Estimated Primary Completion Date : May 2, 2023
Estimated Study Completion Date : November 1, 2023

Intervention Details:
  • Other: Diet
    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


Primary Outcome Measures :
  1. The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy [ Time Frame: 12 Months ]
    enrollment rate

  2. The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy [ Time Frame: 12 Months ]
    drop-out rate

  3. 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


Secondary Outcome Measures :
  1. To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction [ Time Frame: 12 Months ]
    objective response rate (partial + complete response)

  2. To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction [ Time Frame: 12 Months ]
    progression-free survival (PFS)

  3. To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction [ Time Frame: 12 Months ]
    overall survival (OS)


Other Outcome Measures:
  1. The safety and tolerability of the combination of chemotherapy and caloric restriction [ Time Frame: 12 Months ]
    assessed using NCI CTCAE



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • 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
      • 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)
    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05359848


Locations
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United States, New York
University at Buffalo / Great Lakes Cancer Care Recruiting
Buffalo, New York, United States, 14203
Contact: Ashlee Lang, MPH    716-860-0267    alang@kaleidahealth.org   
Contact: Kyle Pasquariello, MA    716-529-6470    kpasquariello@gppconline.com   
Principal Investigator: Roberto Pili, MD         
University at Buffalo / Great Lakes Cancer Care Recruiting
Buffalo, New York, United States, 14206
Contact: Ashlee Lang, MPH    716-860-0267    alang@kaleidahealth.org   
Contact: Kyle Pasquariello, MA    716-529-6470    kpasquariello@gppconline.com   
Principal Investigator: Roberto Pili, MD         
Sponsors and Collaborators
State University of New York at Buffalo
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Responsible Party: Roberto Pili, Associate Dean for Cancer Research and Integrative Oncology, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT05359848    
Other Study ID Numbers: STUDY00005648
First Posted: May 4, 2022    Key Record Dates
Last Update Posted: July 26, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms