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Official title A Pilot, Feasibility Study of Intermittent Caloric Restriction Plus Plant-based Diet in Cancer Patients Receiving Chemotherapy
ClinicalTrials.gov ID: NCT05359848
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Buffalo, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buffalo, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.