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Lifestyle Changes for Cancer (LCBH Trial)

N/A

Waitlist Available

Led By John Jakicic, PhD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of histologically confirmed bladder cancer (non-metastatic) or colorectal adenoma

Under clinical surveillance with no evidence of disease

Must not have

Cancer diagnosis (other than bladder cancer or non-melanoma skin cancer) in the previous 5 years

History of bariatric surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up blood samples will be collected as part of the 12 month assessment (as feasible)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a diet and exercise intervention can prevent telomeres from shortenings in people who have had bladder cancer or colorectal adenoma.

Who is the study for?

This trial is for individuals who have been treated for non-metastatic bladder cancer or colorectal adenoma, with a BMI of 25 to <40. They should not have had any other cancers (except non-melanoma skin cancer) in the past 5 years, no severe high blood pressure, psychiatric treatments, recent significant weight loss or conditions that affect body weight like diabetes.

What is being tested?

The study tests if a combined diet and exercise program can help improve the length of leukocyte telomere (part of your cells that are linked to aging) in patients with histories of bladder cancer or colorectal adenomas compared to just a diet intervention.

What are the potential side effects?

Since this trial involves lifestyle changes such as dietary adjustments and increased physical activity rather than medication, side effects may include muscle soreness from exercise and potential dietary adjustment discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a confirmed history of bladder cancer or colorectal adenoma.

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My cancer is currently not detectable under medical observation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with cancer, other than bladder or non-melanoma skin cancer, in the last 5 years.

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I have had weight loss surgery in the past.

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I have a history of heart issues or conditions needing blood thinners.

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I currently have heart failure or symptoms that could mean a higher risk of a heart event soon.

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I am currently being treated for a psychiatric condition or have been on medication for one in the past year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ blood samples will be collected as part of the 12 month assessment (as feasible)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~blood samples will be collected as part of the 12 month assessment (as feasible)

This trial's timeline: 3 weeks for screening, Varies for treatment, and blood samples will be collected as part of the 12 month assessment (as feasible) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Leukocyte telomere length (LTL) at the 6 month assessment (controlling for appropriate covariates)

Secondary study objectives

8-OHdG level at 3 months (controlling for appropriate covariates)

8-OHdG level at 6 months (controlling for appropriate covariates)

Glutathione

+12 more

Other study objectives

Body Mass Index (BMI) at 3 months (controlling for appropriate covariates)

Body Mass Index (BMI) at 6 months (controlling for appropriate covariates)

Body composition at 3 months (controlling for appropriate covariates)

+21 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: DIETActive Control1 Intervention

Group II: DIET-PAActive Control2 Interventions

This group will be prescribed a Dietary Intervention that reduces energy intake by 500-1000 kcal/day and induces a weight loss of approximately 1-2 pounds per week during the intervention, with the weight loss goal individualized to each participant. In addition, this group will be prescribed moderate-intensity Physical Activity Intervention that will progressively increase to the goal of 250 minutes/week.

0 / 7Eligibility criteria met