Nutrition and Exercise Program for Cancer Survivors

(OnPoint Trial)

Overseen By Tracy Crane, PhD, RDN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Dementia, Psychiatric disease, Stroke, others

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

Compensation: Varies

Number of Visits: Unknown

306 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a personalized nutrition and exercise program, Precise Oncology Interventions in Nutrition and Training (OnPoint), can help cancer survivors improve their diet and maintain physical activity. It targets individuals who have had breast, prostate, or colorectal cancer and are not meeting specific healthy living guidelines. Participants will be divided into groups, with some receiving varying levels of support while others continue with their usual care. Those who completed treatment at least six months ago, are not adhering to a healthy diet or exercise plan, and have internet access might be suitable candidates. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance post-cancer care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor.

What prior data suggests that the Precise Oncology Interventions in Nutrition and Training (OnPoint) program is safe for cancer survivors?

Research has shown that specific nutrition and exercise programs, such as the OnPoint program, are generally safe for cancer survivors. These programs aim to enhance diet and physical activity. Studies have found that participants typically handle these programs well and report few, if any, negative side effects. OnPoint offers personalized diet and exercise plans, similar to those already used in healthcare. Unlike drugs or medical treatments, these programs often carry fewer risks. Overall, this program is designed to be safe and help cancer survivors lead healthier lives. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nutrition and Exercise Program for Cancer Survivors because it explores how tailored lifestyle interventions can enhance recovery and quality of life for cancer survivors. Unlike standard post-cancer care, which often focuses on routine monitoring and general advice, this program offers personalized nutrition and exercise plans (OnPoint) that vary in complexity. These interventions aim to improve physical health and well-being more effectively by adapting to individual needs and capabilities. By investigating the impact of low, moderate, and high complexity interventions, researchers hope to identify the most effective strategies for supporting long-term health in cancer survivors.

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

This trial will compare various levels of personalized nutrition and exercise interventions for cancer survivors. Studies have shown that personalized nutrition and exercise can enhance health in cancer survivors. Research indicates these approaches help survivors improve their diet and increase activity levels. Exercising during cancer treatment has improved physical abilities and reduced fatigue. It also alleviates anxiety and depression. For cancer survivors, maintaining an active lifestyle and a healthy diet can significantly aid recovery and overall well-being. Participants in this trial will join either a control group or one of the experimental groups receiving low, moderate, or high complexity interventions. ^{1 2 3 4 6}

Who Is on the Research Team?

Tracy E Crane, PhD, RDN

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for survivors of breast, prostate, or colorectal cancer. Participants should be interested in improving their diet and physical activity with the help of professionals like dietitians and exercise physiologists.

Inclusion Criteria

I am willing to participate in a 60-90 minute interview.

Healthcare Providers: Provide full- or part-time care in an oncology clinical care setting at Sylvester Comprehensive Cancer Center

Patients: Able to provide consent

Exclusion Criteria

I cannot read or understand English or Spanish.

Any contraindication for diet change or exercising as determined by physician

Engaging in >150 minutes of moderate to vigorous physical activity on average per week for the prior month

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a targeted nutrition and exercise program based on their assigned complexity group

8 weeks

Follow-up

Participants are monitored for dietary and physical activity changes after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Precise Oncology Interventions in Nutrition and Training (OnPoint)

Trial Overview The OnPoint trial tests if a personalized program including nutrition courses, prescriptions, weekly sessions with a dietitian and an exercise physiologist, plus monitoring through Fitbit can improve the health habits of cancer survivors.

How Is the Trial Designed?

Group I: Moderate Complexity Group Experimental Treatment 4 Interventions

Participants in this group will receive the moderate complexity intervention for up to eight (8) weeks.

Group II: Low Complexity Group Experimental Treatment 2 Interventions

Participants in this group will receive the low complexity intervention for up to eight (8) weeks.

Group III: High Complexity Group Experimental Treatment 4 Interventions

Participants in this group will receive the high complexity intervention for up to eight (8) weeks.

Group IV: Control Group Active Control 1 Intervention

Participants randomized to this arm will receive routine care and will not receive any study materials until the end of the study at 24 weeks.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

The Applebaum Foundation

Collaborator

Trials

2

Recruited

330+

Published Research Related to This Trial

The simultaneous stage-matched exercise and diet (SSED) intervention was found to be feasible and well-accepted among 45 breast cancer survivors, with 91% completing the trial and 100% receiving intervention calls.

Participants in the SSED group showed significant improvements in motivational readiness for exercise and diet, as well as better emotional functioning, reduced fatigue, and lower depression compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized pilot test of a simultaneous stage-matched exercise and diet intervention for breast cancer survivors. Kim, SH., Shin, MS., Lee, HS., et al.[2022]

Targeted exercise and nutrition strategies show promise in helping to prevent muscle and bone loss in cancer patients undergoing treatment, indicating a potential area for supportive care.

Despite the encouraging evidence, the optimal combination of exercise and nutrition interventions is still unclear, highlighting the need for further research to fully understand their effects on muscle and bone health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and Nutritional Approaches to Combat Cancer-Related Bone and Muscle Loss. Kiss, N., Baguley, BJ., Dalla Via, J., et al.[2021]

Interventions promoting exercise and healthy body weight are increasingly recognized as important for improving the long-term health of cancer survivors, addressing issues like obesity and physical inactivity.

The review highlights differences in research and clinical priorities between Europe and North America regarding energy balance interventions, suggesting a need for international collaboration to enhance care and outcomes for post-treatment cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to promote energy balance and cancer survivorship: priorities for research and care. Alfano, CM., Molfino, A., Muscaritoli, M.[2023]

Physical activity and exercise therapy are beneficial for cancer patients during treatment and recovery, helping to manage side effects and improve overall outcomes.

Integrating nutrition therapy with physical activity into cancer treatment plans can enhance patient care and should be considered for both cancer patients and the general population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive Care in Oncology-From Physical Activity to Nutrition. Schmidt, T., Süß, P., Schulte, DM., et al.[2022]

Incorporating lifestyle changes, such as diet and physical activity, during and after cancer treatment can significantly improve patients' quality of life and reduce the risk of sarcopenia, which is the loss of muscle mass and strength.

Specifically, a combination of physical activity and the APA-diet can lower the risk of cancer relapse in remission, especially for overweight patients, highlighting the importance of personalized interventions by trained professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nutrition and physical activity (PA) during and after cancer treatment: Therapeutic benefits, pathophysiology, recommendations, clinical management]. Gouez, M., Raynard, B., Marijnen, P., et al.[2022]

A 6-month individualized nutrition intervention for breast cancer patients led to significant reductions in body weight (3.1 kg) and fat mass (2.7 kg), while preserving muscle mass during treatment.

The program, which included tailored dietary plans and regular follow-ups, helped participants make healthier food choices and effectively reduced abdominal and visceral fat without negatively impacting bone density or muscle mass.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An individualized food-based nutrition intervention reduces visceral and total body fat while preserving skeletal muscle mass in breast cancer patients under antineoplastic treatment. Limon-Miro, AT., Valencia, ME., Lopez-Teros, V., et al.[2021]

A consensus was reached among 82 stakeholders, including healthcare professionals and consumers, on 24 essential elements for optimal dietary and exercise referral practices for cancer survivors, indicating a strong agreement on their importance (mean rating of 4.28 or higher).

The study highlights the need for future research to implement and evaluate these essential elements to enhance dietary and exercise care for cancer survivors, ensuring that health professionals have clear guidance in their practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Essential elements of optimal dietary and exercise referral practices for cancer survivors: expert consensus for medical and nursing health professionals. Joseph, R., Hart, NH., Bradford, N., et al.[2022]

The Flinders Living Well Self-Management Program™ (FLW Program) is a feasible and acceptable intervention for Australian cancer survivors, showing promise in maintaining muscle mass and improving exercise capacity during and after treatment.

Participants in the program experienced small but positive changes in body composition and significant improvements in global health status, particularly in those who were post-treatment, suggesting that early implementation during chemotherapy could be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of Self-Management-based Nutrition and Physical Activity Intervention in Cancer Survivors. Miller, M., Zrim, S., Lawn, S., et al.[2018]

Malnutrition and muscle loss are common yet often overlooked issues in cancer patients, but early nutrition screening and intervention can lead to better outcomes.

A multidisciplinary approach that includes nutrition and exercise as standard care can significantly improve patients' physical functioning, quality of life, and treatment results, as recommended by a panel of experts in oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining guidelines and new evidence in oncology nutrition: a position paper on gaps and opportunities in multimodal approaches to improve patient care. Prado, CM., Laviano, A., Gillis, C., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06534918

Precise Oncology Interventions in Nutrition and Training ... The purpose of this study is to see if survivors of breast, prostate, or colorectal cancer who receive a personal referral to a targeted ...

2. news.med.miami.edu news.med.miami.edu/nutrition-exercise-for-cancer-survivors/

Can Nutrition and Exercise Help Cancer Survivors? - InventUM The OnPOINT trial is focusing on precisely catering diet and exercise recommendations to individual cancer survivors.

3. craneresearchlab.org craneresearchlab.org/ongoing-reseach-studies/onpoint

Precision Oncology Interventions in Nutrition and Training ... OnPOINT is a two-arm randomized controlled trial designed to evaluate a tailored nutrition and exercise interventions for cancer survivors.

4. trialstoday.org trialstoday.org/trial/NCT06534918

Precise Oncology Interventions in Nutrition and Training ... The purpose of this study is to see if survivors of breast, prostate, or colorectal cancer who receive a personal referral to a targeted ...

5. academic.oup.com academic.oup.com/jnci/article/117/1/9/7730230

Exercise and Nutrition to Improve Cancer Treatment-Related ... Exercise interventions during cancer treatment improve self-reported physical functioning, fatigue, anxiety, and depression.

6. ancora.ai ancora.ai/de/details/NCT06534918

OnPoint: Precise Oncology Interventions in Nutrition and ... The purpose of this study is to see if survivors of breast, prostate, or colorectal cancer who receive a personal referral to a targeted nutrition and exer.