Exercise and Nutrition Program for Pancreatic Cancer

Overseen By Morgan Bean

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: Unstable cardiac, Pulmonary, Musculoskeletal, others

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

Compensation: Varies

Number of Visits: Unknown

26 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a remote exercise and nutrition program for individuals preparing for pancreatic cancer surgery. It evaluates whether the program is easy for patients to follow and aids in better surgical preparation. Participants will join one of two groups: one receiving both exercise and nutrition guidance, and another receiving only nutrition guidance. This trial suits those diagnosed with pancreatic cancer who plan to undergo surgery, do not regularly exercise, and can manage light physical activity. As an unphased trial, it provides a unique opportunity to contribute to research that may enhance pre-surgery preparation 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. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this prehabilitation program is safe for patients preparing for pancreatic cancer resection?

Research has shown that exercise and nutrition programs are generally safe for people with pancreatic cancer. Previous studies found that patients can enhance their physical abilities without major safety issues, and no significant harmful effects were reported.

This trial includes a remote exercise and nutrition program designed to assist patients before surgery. The program aims to improve overall health through guided physical activity and healthy eating. Due to the nature of this program, the risks are lower compared to drug treatments. For any concerns, consulting a healthcare provider is recommended. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Exercise and Nutrition Program for pancreatic cancer because it offers a unique approach by emphasizing lifestyle changes rather than traditional medical treatments like surgery, chemotherapy, or radiation. This program includes remote exercise and nutritional prehabilitation, which empowers patients to actively participate in their care from the comfort of their homes. The program's innovative use of tele-resistance training and personalized nutrition counseling aims to improve patients' physical and nutritional status, potentially leading to better overall health outcomes and quality of life. By focusing on these non-invasive methods, the trial hopes to discover new ways to support pancreatic cancer patients in their treatment journey.

What evidence suggests that this prehabilitation program is effective for pancreatic cancer?

Research has shown that exercise and good nutrition before surgery can help patients with pancreatic cancer feel better and improve their quality of life. In this trial, participants will join one of two groups. One group will engage in a program that includes physical activity, tele-resistance training, nutrition counseling, and monitoring. The other group will focus on physical activity, nutrition counseling, and monitoring without the tele-resistance training component. Patients with pancreatic cancer that can potentially be removed by surgery have demonstrated significant improvement in their physical abilities when participating in prehabilitation, which includes both exercise and nutrition. This type of program, even when done from home, can help patients become stronger and better prepared for surgery. By focusing on exercise and nutrition before surgery, patients may achieve better results and recover more quickly. ^{2 4 6 7 8}

Who Is on the Research Team?

Pamela Hodul, MD

Principal Investigator

Moffitt Cancer Center

Nathan Parker, PhD, MPH

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals preparing for pancreatic cancer surgery. It's designed to see if a program of exercise and nutrition advice before the operation can help patients.

Inclusion Criteria

My pancreatic cancer is confirmed and might be removable with surgery.

I can take care of myself and am up and about more than 50% of my waking hours.

I am currently receiving chemotherapy that includes both radiation and surgery.

Exclusion Criteria

I regularly exercise, focusing on all major muscle groups twice a week.

Screen failure for exercise safety based on PAR-Q

My pain level is at least 7 out of 10.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants undergo a remote exercise and nutritional prehabilitation program to prepare for pancreatic cancer resection

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after the prehabilitation program

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Remote Exercise and Nutritional Prehabilitation

Trial Overview The study tests a 'prehabilitation' program that includes physical activity, resistance training, and nutrition counseling to improve patient outcomes before pancreatic cancer surgery.

How Is the Trial Designed?

Group I: Physical activity, tele-resistance training, nutrition counseling and monitoring group (RT/N) Experimental Treatment 3 Interventions

Group II: Physical activity, nutrition counseling and monitoring group (PA/N) Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Published Research Related to This Trial

In a study of 137 patients undergoing surgery for pancreatic cancer, a significant prevalence of malnutrition was found, with 62.3% experiencing over 5% weight loss prior to surgery.

Implementing a dietetic intervention for at least 14 days led to an average weight gain of 1.8% and improved handgrip strength by 7.9%, along with significant reductions in gastrointestinal symptoms, highlighting the importance of nutritional support in enhancing recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From prehab to rehab: Nutritional support for people undergoing pancreatic cancer surgery. Bibby, N., Rajai, A., O'Reilly, DA.[2023]

A systematic review of 25 randomized-controlled trials involving 2682 cancer patients found that prehabilitation programs focusing on exercise training did not show clear benefits over usual care in improving health-related quality of life or reducing postoperative complications.

The overall certainty of the evidence was assessed as very low due to serious methodological concerns, indicating that more research is needed to determine the true effectiveness of prehabilitation programs for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation programs for individuals with cancer: a systematic review of randomized-controlled trials. Meneses-Echavez, JF., Loaiza-Betancur, AF., Díaz-López, V., et al.[2023]

Prehabilitation programs before pancreatic surgery can improve postoperative outcomes, such as reducing delayed gastric emptying and shortening hospital stays, based on a systematic review of six studies involving 193 patients.

Supervised exercise programs showed better adherence and effectiveness in improving muscle mass and function compared to unsupervised programs, highlighting the importance of structured prehabilitation in enhancing recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation prior to surgery for pancreatic cancer: A systematic review. Bundred, JR., Kamarajah, SK., Hammond, JS., et al.[2021]

Pancreatic cancer (PC) is associated with malnutrition and sarcopenia, which negatively affect postoperative recovery and overall outcomes, highlighting the need for timely nutritional evaluations and interventions in patients undergoing surgery.

Evidence-based nutritional strategies, including pre- or perioperative medical nutrition and immunonutrition, can significantly reduce postoperative complications and hospital stays, suggesting that proactive nutritional care should be integrated into treatment plans for patients with resectable and borderline resectable PC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunonutrition and prehabilitation in pancreatic cancer surgery: A new concept in the era of ERAS® and neoadjuvant treatment. De Luca, R., Gianotti, L., Pedrazzoli, P., et al.[2023]

In a study of 50 patients with resectable pancreatic adenocarcinoma, engaging in a home-based exercise program led to significant improvements in physical function, as measured by tests like the 6-minute walk test and sit-to-stand test.

Increased levels of light physical activity were linked to better health-related quality of life, while more sedentary behavior was associated with lower quality of life, emphasizing the importance of staying active during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Exercise Prehabilitation During Preoperative Treatment for Pancreatic Cancer Is Associated With Improvement in Physical Function and Quality of Life. Ngo-Huang, A., Parker, NH., Bruera, E., et al.[2023]

This multicenter study is assessing the feasibility of a 4-week home-based exercise prehabilitation program for 30 unfit patients scheduled for pancreatic surgery, focusing on improving their aerobic capacity and functional mobility.

The program includes high-intensity interval training and functional exercises, aiming to enhance patient outcomes and potentially reduce complications in this high-risk group, with results expected to inform future prehabilitation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised Home-Based Exercise Prehabilitation in Unfit Patients Scheduled for Pancreatic Surgery: Protocol for a Multicenter Feasibility Study. Hildebrand, ND., Wijma, AG., Bongers, BC., et al.[2023]

A randomized trial involving 151 patients with pancreatic cancer showed that both a prescribed exercise program and enhanced usual care led to significant improvements in walking distance, with Arm B (exercise) showing a greater mean increase of 27.3 meters compared to 18.6 meters in Arm A (usual care).

While both groups had similar overall activity levels, Arm B participants increased their strength training sessions significantly more, indicating that a structured exercise program can enhance physical fitness in patients preparing for surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Pragmatic Home-based Exercise Program Concurrent With Neoadjuvant Therapy on Physical Function of Patients With Pancreatic Cancer: The PancFit Randomized Clinical Trial. Ngo-Huang, AT., Parker, NH., Xiao, L., et al.[2023]

Neoadjuvant treatment (NAT) is now the standard care for patients with locally advanced pancreatic ductal adenocarcinoma (PDAC), but it can lead to a decline in nutritional status, which may affect treatment tolerance and surgical outcomes.

Implementing a nutritional prehabilitation program during NAT could enhance patients' ability to complete therapy and improve their recovery and survival rates, highlighting the importance of nutritional management in this treatment phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neoadjuvant treatment: A window of opportunity for nutritional prehabilitation in patients with pancreatic ductal adenocarcinoma. Trestini, I., Cintoni, M., Rinninella, E., et al.[2021]

Citations

1. cancer.gov cancer.gov/clinicaltrials/NCI-2024-03273

Remote Exercise and Nutritional Program for ... This clinical trial evaluates the impact of a remote prehabilitation exercise and nutritional program in pancreatic patients before surgery.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7050956/

Home-Based Exercise Prehabilitation During Preoperative ... Conclusions: Patients with potentially resectable pancreatic cancer exhibit meaningful improvement in physical function with prehabilitation; physical activity ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0011384025000632

Effect of triple prehabilitation on patients undergoing ... This study evaluates whether a triple prehabilitation program (exercise, nutrition, psychology) implemented during prehospitalization improves outcomes in PD ...

4. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/prehabilitation-program-aims-to-improve-outcomes-for-older-patients-with-ovarian-or-pancreatic-cancer

Study Explores the Benefit of Prehabilitation - Consult QD A clinical trial is under way to demonstrate whether early interventions can improve outcomes and quality of life for senior patients.

5. withpower.com withpower.com/trial/phase-pancreatic-neoplasms-1-2024-cab1a

Exercise and Nutrition Program for Pancreatic Cancer Research shows that exercise and nutritional prehabilitation can improve physical function and quality of life for patients with pancreatic cancer. Studies ...

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/488096

Remote Exercise and Nutritional Prehabilitation for Pancreatic ... The purpose of the study is to examine the feasibility and acceptability of an exercise and nutrition "prehabilitation" program for patients preparing for ...

7. ancora.ai ancora.ai/en/details/NCT06423963

Remote Exercise and Nutritional Prehabilitation for ... The purpose of the study is to examine the feasibility and acceptability of an exercise and nutrition "prehabilitation" program for patients ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05692323

A Supervised Prehabilitation Program for Patients With ... The purpose of this study is to assess the use of an exercise program in people with pancreatic cancer.