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Chemotherapy
Treatment for Cancer
N/A
Recruiting
Research Sponsored by State University of New York at Buffalo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate liver function: 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
Adults ≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial will use a method of calorie restriction every other day to see if it increases the effectiveness of chemotherapy in treating cancer.
Who is the study for?
This trial is for adults over 18 with documented cancer, set to undergo chemotherapy, and have good blood counts and organ function. They must expect to live at least 6 months but can't join if they're too sick (ECOG status >1), recently took certain steroids or vitamin D, are allergic to contrast dye needed for scans, have an infection needing IV antibiotics, or any issue that might affect study participation.Check my eligibility
What is being tested?
The study tests whether intermittent caloric restriction combined with a plant-based diet before chemotherapy can boost the treatment's effectiveness against tumors. Participants will alternate days of reduced calorie intake prior to receiving their standard chemotherapy regimen.See study design
What are the potential side effects?
Potential side effects may include fatigue due to caloric restriction, possible nutritional deficiencies from the diet change, and typical reactions associated with fasting such as headaches or dizziness. The impact on individuals undergoing chemotherapy could vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver is functioning within the required limits.
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I am 18 years old or older.
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My blood counts meet the required levels for treatment.
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My kidney function is good, with creatinine levels at or below 2.0 mg/dL.
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My cancer is confirmed by lab tests and I can receive chemotherapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy
Secondary outcome measures
To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction
Other outcome measures
The safety and tolerability of the combination of chemotherapy and caloric restriction
Find a Location
Who is running the clinical trial?
State University of New York at BuffaloLead Sponsor
245 Previous Clinical Trials
49,438 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken strong steroids, high dose vitamin D, had serious infections, or allergies to contrast dye recently.My liver is functioning within the required limits.I need assistance with my daily activities due to my health condition.I have no health issues that would stop me from following the study's requirements.I am 18 years old or older.My blood counts meet the required levels for treatment.My kidney function is good, with creatinine levels at or below 2.0 mg/dL.My cancer is confirmed by lab tests and I can receive chemotherapy.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants is the trial looking to recruit?
"Yes indeed. According to information on clinicaltrials.gov, this medical trial is presently recruiting participants and was first posted on April 15th 2022 with the most recent update being July 25th 2022. The research initiative seeks 30 people from a single location."
Answered by AI
Is access to this research trial currently available for individuals?
"Verified, the trial is actively seeking eligible patients. It was initially published on April 15th 2022 and lastly edited on July 25th 2022. This study needs 30 participants from a single site to take part in the investigation."
Answered by AI
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