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

Trial Summary

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 data supports the effectiveness of the treatment OnPoint for cancer survivors?

Research shows that combining exercise and nutrition can help cancer survivors by reducing muscle and bone loss, improving physical and psychological health, and minimizing treatment side effects. These approaches are recommended for cancer care and can improve overall outcomes for survivors. ^{1 2 3 4 5}

Is the Nutrition and Exercise Program for Cancer Survivors safe for humans?

The Nutrition and Exercise Program for Cancer Survivors, including variations like OnPoint, has been shown to be safe for cancer survivors, with studies indicating no significant safety concerns and potential benefits such as improved muscle mass and quality of life. ^{1 6 7 8 9}

How is the OnPoint treatment different from other treatments for cancer survivors?

The OnPoint treatment is unique because it combines personalized nutrition and exercise programs specifically designed for cancer survivors, focusing on improving energy balance and reducing the chronic effects of cancer. Unlike standard treatments, it emphasizes individualized interventions to enhance prognosis and survivorship outcomes through tailored diet and physical activity plans. ^{1 2 3 4 5}

What is the purpose of this trial?

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 exercise program will be able to eat a healthier diet and be more physically activity.

Research Team

Tracy E Crane, PhD, RDN

Principal Investigator

University of Miami

Eligibility Criteria

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: Agree to be randomly assigned to any study group

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

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

Treatment Details

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.

Participant Groups

Group I: Moderate Complexity Group Experimental Treatment 5 Interventions

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

Group II: Low Complexity Group Experimental Treatment 3 Interventions

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

Group III: High Complexity Group Experimental Treatment 5 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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Exercise and Nutritional Approaches to Combat Cancer-Related Bone and Muscle Loss. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Supportive Care in Oncology-From Physical Activity to Nutrition. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Interventions to promote energy balance and cancer survivorship: priorities for research and care. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Randomized pilot test of a simultaneous stage-matched exercise and diet intervention for breast cancer survivors. [2022]

5. Germany 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A Pilot Study of Self-Management-based Nutrition and Physical Activity Intervention in Cancer Survivors. [2018]

7. France pubmed.ncbi.nlm.nih.gov

[Nutrition and physical activity (PA) during and after cancer treatment: Therapeutic benefits, pathophysiology, recommendations, clinical management]. [2022]

8. Germany 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. [2022]

9. England 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. [2021]