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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special program of nutrition and exercise can help American Indian patients with obesity-related cancer better prepare for surgery. Researchers seek to understand if this "prehabilitation" intervention can alter specific blood and tumor markers that indicate inflammation. The trial is recruiting participants diagnosed with obesity-related solid tumor cancer who are scheduled for surgery at least three weeks later. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance surgical outcomes for future patients.

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 prior data suggests that this prehabilitation intervention is safe for American Indian patients with obesity-related cancer?

Research has shown that prehabilitation is generally safe for patients. One study found that prehabilitation safely reduced belly fat in obese patients with stomach cancer. Another study discovered that a high-protein prehabilitation program helped patients maintain their physical health during chemotherapy.

Most patients complete prehabilitation without major issues, as acceptance and completion rates remain high. Evidence suggests that prehabilitation can lead to shorter hospital stays and reduced time in intensive care.

Overall, these findings indicate that prehabilitation is well-tolerated and can improve recovery for patients undergoing surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Prehabilitation Intervention for obesity-related cancer because it focuses on improving patient readiness for surgery through a tailored program combining nutrition and exercise. Unlike traditional treatments that primarily target the cancer itself, this intervention aims to enhance overall health and modify inflammatory biomarkers, potentially leading to better surgical outcomes. The unique aspect of this approach is its focus on a short, intensive pre-surgery period, which could offer patients a non-invasive way to boost recovery and resilience, setting a new standard for preoperative care.

What evidence suggests that this prehabilitation intervention is effective for obesity-related cancer?

Research has shown that preparing for surgery with exercise and good nutrition, known as prehabilitation, can lead to better surgery results and faster recovery. Studies have found that it can reduce belly fat by 17% and improve overall health. For cancer patients, prehabilitation is linked to better physical ability and less fatigue. It also decreases the chance of post-surgery complications. This trial will implement a tailored prehabilitation program for individuals with obesity-related cancers preparing for surgery, making it a promising option for improving outcomes in this patient group. ^{4 6 7 8 9}

Who Is on the Research Team?

Jennifer Erdrich, MD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

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Prehabilitation: Impact on Postoperative Outcomes - PMC

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Safety, Compliance, and Efficacy of Prehabilitation in ...

No adverse events were observed, and the visceral fat area reduced by 17%. To the best of our knowledge, this is the first report to ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S074879832400800X

A scoping review of preoperative weight loss interventions ...

All reported weight reductions of −1.3 to −6 kg and 4.5–6.9 % (n = 7), compared to baseline. Three of four non-randomized trials observed a reduction in ...

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bmccancer.biomedcentral.com

bmccancer.biomedcentral.com/articles/10.1186/s12885-024-13023-w

Efficacy of Prehabilitation in cancer patients: an Rcts ...

Patients with cancer (PwC) who undergo specific treatments reported greater fatigue and reduced functional capacity as predominant outcomes, ...

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Impact of Prehabilitation in Major Gastrointestinal ...

Multimodal prehabilitation programs demonstrated significant improvements in functional capacity, reductions in postoperative complications, ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12334139/

Safety, Compliance, and Efficacy of Prehabilitation in ...

Prehabilitation can safely reduce visceral fat area before performing minimally invasive gastrectomy in patients with gastric cancer who are obese. Keywords: ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S2161831325000286

Prehabilitation Strategies: Enhancing Surgical Resilience ...

The study found that prehabilitation with high-protein supplementation helped prevent the decline in functional and physical status during chemotherapy. However ...

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bmcgastroenterol.biomedcentral.com

bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-025-03626-3

The role of exercise-based prehabilitation in enhancing ...

The acceptance and completion rates of prehabilitation were commendably high at 61% (95% CI: 47–75%) and 90% (95% CI: 87–93%), respectively, ...

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mdpi.com

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Prehabilitation in Adults Undergoing Cancer Surgery

Prehabilitation is a unimodal or multimodal strategy that aims to increase a patient's functional capacity to reduce postoperative complications.