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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining diet and exercise improves the health of individuals with a history of non-metastatic bladder cancer or colorectal adenoma (a type of colon polyp) more effectively than dieting alone. One group of participants will follow a diet plan (Dietary Intervention) to lose weight, while another group will follow the same diet and incorporate regular moderate exercise (Physical Activity Intervention). Individuals with a BMI between 25 and less than 40, who have a history of these conditions and are currently disease-free, might be suitable candidates. As an unphased trial, this study allows participants to contribute to valuable research that could enhance lifestyle recommendations for others with similar health histories.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking daily or extended-release psychotropic medications, you may not be eligible to participate.

What prior data suggests that this combined diet and exercise intervention is safe for individuals with histories of non-metastatic bladder cancer or colorectal adenoma?

Research has shown that changing one's diet is generally safe, even for those undergoing cancer treatment. One study found these changes to be helpful and safe, particularly during chemotherapy, allowing dietary adjustments without major safety concerns.

Studies also confirm the safety of combining diet changes with exercise. This approach can alleviate issues like tiredness, anxiety, and depression for individuals in cancer treatment. Another study found that adding exercise to a healthy diet may lead to better health outcomes for cancer patients, emphasizing its safety and benefits.

Both diet changes alone and combined with exercise are well-tolerated by most people. Research has not linked these lifestyle changes to any serious side effects, indicating that trying these changes is generally considered safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Lifestyle Changes for Cancer trial because it explores how combining dietary changes and physical activity can be a powerful approach to cancer care. Unlike standard treatments like surgery, chemotherapy, or radiation, which directly target cancer cells, this trial focuses on lifestyle interventions to potentially improve overall health and support cancer treatment. The dietary intervention aims for a sustainable weight loss through reduced energy intake, while the physical activity component gradually increases to 250 minutes of moderate exercise per week. This holistic approach might offer patients a way to enhance their quality of life and treatment outcomes naturally.

What evidence suggests that this trial's treatments could be effective for cancer survivors?

This trial will compare a Dietary Intervention with a combined Dietary and Physical Activity Intervention. Research has shown that dietary changes can slow tumor growth and enhance the effectiveness of cancer treatments. Some studies suggest that specific diets can improve cancer outcomes and help manage treatment side effects. Participants in this trial may receive either a Dietary Intervention alone or in combination with a Physical Activity Intervention. Evidence indicates that combining dietary changes with exercise can reduce body weight and inflammation, potentially leading to better health after cancer treatment. Physical activity, along with a healthy diet, also improves physical function and reduces fatigue and anxiety in cancer survivors. These strategies may be promising for improving the health of individuals with a history of bladder cancer or colorectal adenoma. ^{1 3 4 6 7}

Who Is on the Research Team?

Dana Bovbjerg, PhD

Principal Investigator

University of Pittsburgh

John Jakicic, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11223872/

Dietary interventions in cancer: a systematic review of all ... Observational studies and nonrandomized trials have frequently reported improved cancer outcomes with adherence to various specific diets (2,3). However, these ...

2. nature.com nature.com/articles/s41392-024-01771-x

Effects of dietary intervention on human diseases Emerging evidence indicates that dietary interventions might affect the nutrient availability in tumors, thereby increasing the efficacy of ...

3. academic.oup.com academic.oup.com/jnci/article/115/8/886/7172380

nutrition as prevention for improved cancer outcomes | JNCI ... Overall, nutritional intervention studies (see evidence review Chapter 7 (7)) showed mixed results for the effectiveness of supplementation ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1471491423000746

Dietary interventions and precision nutrition in cancer therapy Recent studies have demonstrated the powerful potential of particular diets in preventing tumorigenesis, delaying tumor growth, and improving the effectiveness ...

5. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)34566-1/fulltext

Systematic review and meta-analysis of the evidence for ... This systematic review suggests an overall positive effect of nutritional interventions during chemo(radio)therapy on BW.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10290234/

Nutrition as prevention for improved cancer health outcomes Only 30% to 50% of cancer patients at risk for malnutrition receive nutrition intervention (12,13). Considering that an estimated 1.9 million individuals were ...

7. mdpi.com mdpi.com/1718-7729/32/1/3

Nutritional Counseling During Chemotherapy Treatment In conclusion, nutritional interventions were feasible and safe for patients undergoing chemotherapy and demonstrated preliminary efficacy to improve ...