Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263, United States
Location contact
Eric Kauffmann, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07714018
This clinical trial compares two different weight-loss programs, daily continuous calorie energy reduction (CER) versus (vs.) 5:2 intermittent fasting (IF), in preventing progression of kidney (renal) cancer among patients with one or more small renal masses (SRM) undergoing active surveillance (AS). Kidney cancer patients tend to have changes in metabolism that may increase body weight, but weight-loss strategies that work for best for these patients are unknown. The CER program requires a set daily limit for calories. The IF program requires fasting for 2 days a week and normal eating for the remaining 5 days. Both will include self-monitoring with interventionist feedback. This trial may help researchers determine whether the IF program works better than the CER program in improving weight loss, physical health, and/or reducing the risk of kidney cancer progression among patients with small renal masses undergoing AS
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Buffalo, New York, 14263, United States
Eric Kauffmann, MD
PRINCIPAL_INVESTIGATOR
PRIMARY OBJECTIVES:
I. Adapt two evidence-based behavioral weight loss intervention programs (IF and CER) with a goal to cause weight loss in SRM patients on AS.
II. Determine the feasibility of the two intervention programs (IF and CER).
SECONDARY OBJECTIVE:
I. Measure and explore preliminary effect sizes of IF vs. CER on body weight, diet, body composition, tumor growth, and rates of clinical progression and invasive treatment conversion
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The IF intervention will instruct participants how to fast safely, how to conduct a 5:2 fast, and encourage moderate physical activity. Self-monitoring with interventionist feedback will also be included
Lessons about lowering caloric intake each day and moderate physical activity with self-monitoring and interventionist feedback
Time frame: At 6 months
This will assess the rate of eligible persons who enroll after invitation and the mean proportion of intervention components completed by arm and participant
Time frame: At baseline and at 6 months
Will be assessed based on radiologic imaging. Within-group differences between baseline and 6 months will be examined using paired t-tests or Wilcoxon signed-rank tests for continuous variables, and McNemar's test for categorical variables.
Time frame: Up to 6 months
defined based on radiologic tumor size (> 4 cm), stage (> cT1a) and growth rate (> 5 mm/year for < 3 cm size; > 3 mm/year for tumor size > 3 cm), in addition to biopsy histology (high grade or unclassified renal cell carcinoma histologic subtype) and patient symptomology (bleeding or paraneoplastic symptoms/signs attributable to the tumor), as per the International Consultation for Urologic Disease guidelines
Time frame: Baseline and 6 months
Participants will complete 3 recalls over the phone regarding dietary intake over a prior 24-hour period.
Time frame: Baseline and at 6 months
Will be measured using a body composition monitor, which uses bioelectrical impedance analysis to measure whole body and segmental body composition, including trunk fat..
Roswell Park Cancer Institute
Other
Development and Analysis of Weight Loss Programs for Renal Cell Carcinoma Patients on Active Surveillance
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07636785
Adenocarcinoma, Bronchial Neoplasms
Scottsdale, Arizona, United States
View Trial DetailsNCT07636148
Adenocarcinoma, Bone Cancer Metastatic
Lyon, Auvergne-Rhône-Alpes, France
View Trial DetailsNCT07627464
Adenocarcinoma, Carcinoma
Beijing, China
View Trial DetailsNCT07620574
Adenocarcinoma, Cancer
View Trial Details