Lifestyle Changes for Cancer

(LCBH Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must not be taking: Psychotropic medications

Disqualifiers: Diabetes, Heart failure, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 months

8 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of the research is to provide a first critical test of the novel scientific idea that a combined diet and exercise intervention may ameliorate shortening of leukocyte telomere length (LTL) in individuals with histories of successfully treated non-metastatic bladder cancer (BC) or colorectal adenoma (CRA) compared to a diet only intervention.

Research Team

Dana Bovbjerg, PhD

Principal Investigator

University of Pittsburgh

John Jakicic, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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.

Inclusion Criteria

Your body mass index (BMI) is between 25.0 and less than 40 kg/m2, which means you have a certain level of body weight.

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

My cancer is currently not detectable under medical observation.

Exclusion Criteria

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

You have an eating disorder that would make it unsafe for you to lose weight or engage in physical activity.

You have a history of alcohol or drug abuse.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a diet and exercise intervention to study its effects on leukocyte telomere length

6 months

Monthly assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessments at 3, 6, and 12 months

Treatment Details

Interventions

• Dietary Intervention
• Physical Activity Intervention

Trial Overview 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.

Participant Groups

Group I: DIET Active Control 1 Intervention

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.

Group II: DIET-PA Active Control 2 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.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+