Nutrition & Exercise Prehabilitation for Obesity-Related Cancer

Overseen By Melissa Carton

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Disqualifiers: Chemotherapy, Digestive disease, Cardiac disease, others

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

Compensation: Varies

Number of Visits: Unknown

30 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. However, if you are receiving chemotherapy during the preoperative study period, you would be excluded from participating.

What data supports the effectiveness of the treatment Prehabilitation Intervention for obesity-related cancer?

Research shows that weight loss and physical activity can improve body composition and potentially influence cancer-related biomarkers in breast cancer patients. Prehabilitation, which includes nutrition and exercise, aims to enhance functional capacity before cancer treatment, suggesting potential benefits for patients with obesity-related cancer. ^{1 2 3 4 5}

Is the Nutrition & Exercise Prehabilitation for Obesity-Related Cancer generally safe for humans?

The research on prehabilitation, which includes nutrition and exercise interventions, suggests it is generally safe for humans, as it is used to improve health outcomes and reduce treatment-related complications in cancer patients. However, the studies highlight the need for standardized nutritional assessments and monitoring to ensure safety and effectiveness. ^{1 4 6 7 8}

How does the Prehabilitation Intervention treatment differ from other treatments for obesity-related cancer?

The Prehabilitation Intervention is unique because it combines nutrition and exercise to improve patients' physical condition before cancer treatment, aiming to enhance recovery and outcomes. Unlike standard treatments that focus solely on medical or surgical interventions, this approach emphasizes preparing the body through lifestyle changes, which is not commonly integrated into traditional cancer care. ^{3 4 5 7 9}

What is the purpose of this trial?

The purpose of this study is to assess the feasibility of a prehab intervention among American Indian (AI) patients diagnosed with obesity-related cancer and measure inflammatory biomarkers to evaluate the preliminary impact of the trial intervention. The central hypothesis is that this community-informed prehab intervention will demonstrate feasibility, patient acceptability, and modulation of host and tumor-microenvironment inflammatory biomarkers. Aim 1: Implement the prehab translational clinical trial for AI patients with obesity-related solid tumor cancer scheduled for surgery. Aim 2 Measure host and tumor-microenvironment (TME) biomarkers using paired serum and tissue samples to compare baseline and post-intervention levels of expression. Serum markers include CRP, IL-6, IL-10, TNFa, IGF-1, VEGF, complete blood count (CBC) with differential, comprehensive metabolic panel (CMP), and prealbumin. Tissue markers include Ki67, insulin receptor, TNFa, NFKB, NOS2, and cleaved caspase 3. Aim 3: (optional exploratory aim): Assess differential expression of inflammatory genes in the TME using tumor tissue samples to compare baseline and post-intervention levels of expression. This will be done with a panel that analyzes inflammatory genes only.

Research Team

Jennifer Erdrich, MD

Principal Investigator

University of Arizona

Eligibility Criteria

This trial is for American Indian patients who have obesity-related cancers and are scheduled for surgery. It's designed to test a prehabilitation program that includes nutrition and exercise, aiming to improve their health before treatment.

Inclusion Criteria

My cancer is related to obesity and affects organs like the thyroid, breast, or liver.

I am scheduled for surgery to remove my tumor.

Enrolled member of the San Carlos Apache nation

Exclusion Criteria

I have a digestive condition that limits my diet changes.

I am currently receiving or will receive chemotherapy before surgery.

Allergy to the foods intended for the nutrition intervention

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation Intervention

Participants engage in a tailored prehab program involving nutrition and exercise to modify inflammatory biomarkers before surgery

3 weeks

Daily exercise and bi-weekly fitness sessions

Follow-up

Participants are monitored for changes in inflammatory biomarkers and lifestyle behavior post-intervention

2 weeks

Post-intervention assessments

Treatment Details

Interventions

• Prehabilitation Intervention

Trial Overview The study tests a 'prehab' intervention combining diet and physical activity to see if it can change certain blood and tissue markers linked with inflammation in these cancer patients. The effects will be measured before and after the intervention.

Participant Groups

Group I: Prehabilitation Intervention Experimental Treatment 1 Intervention

This is a single-arm, pre-post, window of opportunity trial. The tailored prehab program will be implemented for AI cancer patients preparing for cancer surgery for a 3-week duration in the preoperative window of opportunity. The prehab intervention is designed to modify inflammatory biomarkers in paired pre/post-intervention blood and tissue samples. 30 individuals who are 18-80 years old with a diagnosis of obesity-related solid tumor cancer, scheduled at least 3 weeks out from cancer surgery who are receiving care at SCAHC will be recruited over the duration of the study. Blood samples will be collected before and after the prehab, and inflammatory biomarkers will be measured in the paired pre/post blood sample. Unstained slides from the diagnostic biopsy and resected tumor specimen will be requested, and inflammatory biomarkers will be measured in the paired pre/post tissue sample.

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The ENERGY study is a 4-year clinical trial involving 693 overweight or obese women with early-stage breast cancer, aimed at demonstrating the feasibility of sustained weight loss and its impact on quality of life and co-morbidities.

The trial's intervention includes a cognitive-behavioral weight loss program, which could establish weight loss support as a new standard of care for breast cancer survivors, potentially improving their clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing breast cancer recurrence with weight loss, a vanguard trial: the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial. Rock, CL., Byers, TE., Colditz, GA., et al.[2021]

A scoping review of 110 prehabilitation studies in cancer treatment revealed that while many interventions focus on multimodal or exercise-only approaches, only 34% included a nutrition component, highlighting a significant gap in nutritional integration.

The review found that nutritional assessments were often inconsistent and not based on validated tools, with two-thirds of studies failing to monitor or evaluate the effectiveness of nutrition interventions, suggesting a need for standardized practices in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Landscape of Nutrition Within Prehabilitation Oncology Research: A Scoping Review. Gillis, C., Davies, SJ., Carli, F., et al.[2023]

Prehabilitation, which includes exercise, nutrition, and psychoeducation, has been shown to improve various health outcomes such as gait, cardiopulmonary function, and mood in cancer patients 30 days post-treatment, based on a review of 16 randomized controlled trials with 2017 participants.

Combining prehabilitation with rehabilitation yielded greater improvements in physical functioning compared to prehabilitation alone, highlighting the need for larger studies to confirm these benefits and enhance long-term outcomes for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation for adults diagnosed with cancer: A systematic review of long-term physical function, nutrition and patient-reported outcomes. Faithfull, S., Turner, L., Poole, K., et al.[2020]

Multimodal prehabilitation, which includes both nutrition and exercise, can improve functional walking capacity and pulmonary function in lung cancer patients before surgery, although it does not seem to affect postoperative outcomes.

A nutrition-only intervention showed a significant reduction in postoperative complications, suggesting that optimizing preoperative nutrition may provide important benefits that need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of preoperative nutrition and multimodal prehabilitation on functional capacity and postoperative complications in surgical lung cancer patients: a systematic review. Ferreira, V., Lawson, C., Ekmekjian, T., et al.[2021]

In a study of colorectal and esophageal cancer patients undergoing the Fit4Surgery prehabilitation program, 56.3% achieved the target protein intake of ≥1.5 g/kg body weight per day, indicating good adherence to the nutritional intervention.

Mean daily protein intake significantly increased from 1.20 g/kg to 1.61 g/kg after prehabilitation, demonstrating that dietary counseling and whey protein supplementation effectively enhance nutritional status before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to and Efficacy of the Nutritional Intervention in Multimodal Prehabilitation in Colorectal and Esophageal Cancer Patients. van Exter, SH., Drager, LD., van Asseldonk, MJMD., et al.[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]

References

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

An international review and meta-analysis of prehabilitation compared to usual care for cancer patients. [2022]

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

Reducing breast cancer recurrence with weight loss, a vanguard trial: the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial. [2021]

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

Randomized trial of weight loss in primary breast cancer: Impact on body composition, circulating biomarkers and tumor characteristics. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Current Landscape of Nutrition Within Prehabilitation Oncology Research: A Scoping Review. [2023]

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

What are the most effective exercise, physical activity and dietary interventions to improve body composition in women diagnosed with or at high-risk of breast cancer? A systematic review and network meta-analysis. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Prehabilitation for adults diagnosed with cancer: A systematic review of long-term physical function, nutrition and patient-reported outcomes. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

Effects of preoperative nutrition and multimodal prehabilitation on functional capacity and postoperative complications in surgical lung cancer patients: a systematic review. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Adherence to and Efficacy of the Nutritional Intervention in Multimodal Prehabilitation in Colorectal and Esophageal Cancer Patients. [2023]

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

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