20 Participants NeededMy employer runs this trial

Weight Loss Programs for Kidney Cancer

AR
Overseen ByASK RPCI
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Roswell Park Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the most effective weight-loss strategy for individuals with kidney cancer who have small renal masses and are under observation without immediate treatment. It compares two programs: Continuous Energy Restriction, which limits daily calories, and intermittent fasting, which involves fasting for 2 days a week and eating normally for 5 days. Researchers aim to determine which plan better supports weight loss, physical health, and potentially slows cancer progression. Individuals with kidney cancer, a body mass index (BMI) of 25 or higher, and no recent significant weight loss may be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to enhance understanding of effective weight-loss strategies for kidney cancer patients.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both continuous energy restriction (CER) and intermittent fasting (IF) are generally safe for most people, including those with cancer. CER involves reducing calorie intake, and studies have found that cancer patients can tolerate this well. This approach is similar to the ketogenic diet, which is safe for individuals with kidney cancer. No major safety issues have been reported with these methods.

Intermittent fasting may help reduce fatigue and nausea in cancer patients and is considered safe, even when combined with treatments like chemotherapy. Some research suggests that fasting might enhance the immune system's ability to fight cancer.

Both approaches appear safe, but individual experiences can vary. Always consult a healthcare provider before making significant dietary changes.12345

Why are researchers excited about this trial?

Researchers are excited about exploring weight loss programs like Continuous Energy Restriction (CER) and Intermittent Fasting (IF) for kidney cancer because these approaches are non-invasive and focus on dietary changes rather than medication or surgery. Unlike standard treatments that might include surgery, targeted therapies, or immunotherapy, these methods aim to potentially slow cancer progression by leveraging metabolic changes induced by calorie restriction. The CER program involves a consistent reduction in calorie intake, while the IF program incorporates two fasting days each week, offering flexibility and potentially enhancing patient adherence. These strategies could offer a complementary option that supports traditional cancer treatments by improving overall health and potentially impacting cancer progression through metabolic pathways.

What evidence suggests that this trial's weight-loss programs could be effective for kidney cancer?

This trial will compare two weight loss programs for kidney cancer: Continuous Energy Restriction (CER) and Intermittent Fasting (IF). Research has shown that consistently eating fewer calories, known as CER, may help slow the progression of kidney cancer. Studies comparing different weight-loss methods have found that reducing daily calorie intake can help manage weight and might also slow the disease in kidney cancer patients.

Intermittent Fasting (IF), which involves alternating between eating and fasting periods, also shows promise in cancer treatment. Some research suggests that fasting can make cancer cells more sensitive to treatments and help protect healthy cells. Both CER and IF, tested in separate arms of this trial, have shown potential benefits for managing weight and slowing cancer progression. However, more research is needed to confirm their effectiveness specifically for kidney cancer.26789

Who Is on the Research Team?

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Eric Kaufmann

Principal Investigator

Roswell Park Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for people with small kidney tumors who are being closely monitored instead of having immediate treatment. Participants should be able to follow a weight-loss program and self-monitor their progress.

Inclusion Criteria

I am not taking any medication that affects my weight.
Not pregnant or lactating
No more than 5% body weight loss in the past 3 months
See 6 more

Exclusion Criteria

I have had weight loss surgery in the past 10 years.
BMI < 25 kg/m^2
Medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either the CER or IF weight loss program for 6 months

6 months
Regular self-monitoring with interventionist feedback

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Continuous Energy Restriction (CER)
  • Intermittent Fasting

Trial Overview

The study compares two weight loss methods: daily calorie restriction versus intermittent fasting (fasting 2 days per week, normal eating the other days). Both groups get support and feedback while researchers track cancer progression and health changes.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Arm I - CER ProgramActive Control1 Intervention
Group II: Arm II - IF ProgramActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials
427
Recruited
40,500+

Citations

Survival benefits of Cytoreductive Nephrectomy in patients ...

CN was associated with a 71% reduction in all-cause mortality (HR = 0.29, 95% CI = 0.25–0.33) and RCC-specific mortality (HR = 0.29, 95% CI = 0.25–0.34). Five- ...

Comparing Two Weight Loss Programs for the Prevention ...

This clinical trial compares two different weight-loss programs, daily continuous calorie energy reduction (CER) preventing progression of kidney (renal) ...

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4381-Renal cell carcinoma definitive stereotactic EBRT

INTERPRETATION: SABR is effective and safe in the long term for patients with primary renal cell carcinoma. Single-fraction SABR might yield less local failure ...

The role of diet in renal cell carcinoma incidence - PMC - NIH

Increased intake of vegetables and vitamin C is negatively associated with RCC risk. Moderate drinking might be beneficial for Europeans and ...

Nutrient intake and renal cancer: molecular pathways ...

Antioxidant gene signature impacts the immune infiltration and predicts the prognosis of kidney renal clear cell carcinoma.

New Team Science Award Aims to Unlock Mysteries of Kidney ...

The database comprises clinical information, including imaging and pathology data from more than 800 Sylvester kidney cancer patients dating ...

Feasibility and Safety of a Ketogenic Diet During Systemic ...

The CETOREIN pilot study demonstrates that a ketogenic diet is feasible and safe for selected patients with metastatic renal cell carcinoma, although long-term ...