Exercise and Behavioral Training for Pancreatic Cancer

Overseen By Matthew H. Katz, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Unstable cardiac, Pulmonary disease, Neuroendocrine cancer, others

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

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if regular exercise and behavioral training can boost physical activity in people with pancreatic cancer preparing for surgery after chemotherapy or radiation. Participants will either follow a multimodal exercise and nutrition program, which includes behavioral skills training, or receive standard care with guidance to stay active. The study suits those with pancreatic cancer who are set for preoperative treatment and expect surgery in at least six weeks. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance pre-surgery care 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 exercise and behavioral training is safe for pancreatic cancer patients?

Research has shown that exercise is safe and manageable for people with pancreatic cancer. One study found that exercise improved the quality of life for these patients. Another study discovered that supervised exercise during cancer treatment was safe and well-received. A 12-week exercise program proved safe and feasible for patients with advanced lung or pancreatic cancer.

These findings suggest that regular exercise and learning behavioral skills are generally safe and well-tolerated during cancer treatment. Reports have not indicated any major negative effects from these programs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential benefits of integrating multimodal exercise and behavioral skills training for pancreatic cancer patients. Unlike traditional treatments that primarily focus on chemotherapy and radiation, this approach emphasizes physical rehabilitation and psychological support as vital components of recovery. The unique combination of moderate-intensity aerobic exercises, strength training, and personalized nutritional and behavioral counseling aims to boost physical abilities, motivation, and quality of life. By addressing both physical and mental health, this trial seeks to uncover whether these additional supportive strategies can improve overall outcomes for patients recovering from pancreatic cancer.

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

Research shows that exercise can be safe and beneficial for people with pancreatic cancer. Studies have found that patients who exercise regularly during treatment often feel better and improve their quality of life. Some patients also maintain or even build muscle strength, which is crucial for staying strong. This trial will compare two approaches: Arm A, where participants receive standard care and are encouraged to remain active, and Arm B, which involves a Multi-Modal Exercise and Nutrition Program (MMENP). Engaging in different types of exercises, known as multimodal exercise, can help reduce body fat and enhance overall physical ability. Customized exercise programs have also been linked to better outcomes for those undergoing surgery for pancreatic cancer. Overall, exercise and behavior training may help participants stay active and improve well-being during cancer treatment. ^{1 2 3 6 7}

Who Is on the Research Team?

Matthew H. Katz, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with any type of biopsy-proven pancreatic cancer, who are set to receive pre-surgery chemotherapy and/or radiation. Participants must understand the study, be willing to maintain exercise logs, have phone or email access for communication, and not start surgery within 6 weeks from joining.

Inclusion Criteria

Able to understand the exercise program

I am scheduled for preoperative therapy, including chemotherapy or radiation.

My pancreatic cancer diagnosis was confirmed through a biopsy.

Exclusion Criteria

Unable to complete the baseline assessment questionnaires or functional assessments

My pain level is 7 or higher on a scale of 1 to 10.

My cancer has come back after surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Therapy

Participants receive chemotherapy and/or radiation before surgery

Varies based on individual treatment plans

Regular visits as per chemotherapy/radiation schedule

Surgery and Recovery

Participants undergo standard-of-care surgery and initial recovery

3-6 weeks post-surgery

1 visit (in-person) for surgery and follow-up

Exercise and Behavioral Training

Participants in Arm B engage in structured exercise and behavioral skills training

Up to 7 months post-surgery

Weekly phone calls for the first 4 weeks, then bi-weekly

Follow-up

Participants are monitored for fitness, quality of life, and tumor vasculature changes

3-7 months post-surgery

Regular assessments and questionnaires

What Are the Treatments Tested in This Trial?

Interventions

• Multimodal Exercise and Behavioral Skills Training

Trial Overview The PancFit study tests if a program combining regular exercise and behavioral skills training can boost physical activity in pancreatic cancer patients awaiting standard-of-care surgery after chemo/radiation therapy. It includes questionnaires, counseling, and physical assessments.

How Is the Trial Designed?

Group I: Arm B: Multi-Modal Exercise and Nutrition Program (MMENP) Experimental Treatment 5 Interventions

After completion of chemotherapy and/or radiation, 3-6 weeks after surgery, then 3-7 months after surgery: Participants complete 4 questionnaires about physical abilities, motivation, and quality of life. Participant's hand grip strength measured. Participants arm strength measured. Participants asked to rise from a chair without using their arms to push off. Participants complete a 6-minute walk test to see how far participant can walk in 6 minutes. Participants complete a nutritional questionnaire and receive nutritional counseling. Participants receive educational materials and personalized counseling based on participant's answers. Participants complete moderate-intensity aerobic exercise 5 days each week. Participants complete strength training exercises 2 times per week. Participants contacted by phone by member of study staff 1 time each week for the first 4 weeks, and then every 2 weeks after that for behavioral skills training and to see how participant is doing.

Group II: Arm A: Standard of Care (SOC) Experimental Treatment 4 Interventions

After completion of chemotherapy and/or radiation, 3-6 weeks after surgery, and then 3-7 months after surgery: Participants complete 4 questionnaires about physical abilities, motivation, and quality of life. Participant's hand grip strength measured. Participants arm strength measured using an arm curl test. Participants asked to rise from a chair without using their arms to push off. Participants complete a 6-minute walk test to see how far participant can walk in 6 minutes. Participants complete a nutritional questionnaire and receive nutritional counseling. Participants receive educational materials and personalized counseling based on participant's answers. Participants encouraged to remain active during chemotherapy and/or radiation. Participants receive a booklet that contains a stretching guide with full-body stretches and safety.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

In a study involving 20 patients with potentially resectable pancreatic adenocarcinoma, 75% adhered to a home-based exercise program during preoperative chemotherapy, reporting an average of 156 minutes of exercise weekly.

The exercise program was safe, with no adverse events reported, and significantly increased physical activity levels in patients who initially had low baseline activity, suggesting that exercise can be effectively integrated into treatment for pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based exercise during preoperative therapy for pancreatic cancer. Ngo-Huang, A., Parker, NH., Wang, X., et al.[2023]

A 12-week supervised exercise program for 22 patients with pancreatic cancer showed significant improvements in functional ability, muscle strength, and balance, with no serious adverse events reported, indicating that exercise is safe during nonsurgical treatment.

Patients who continued exercising beyond the initial 12 weeks maintained their physical improvements, suggesting that ongoing exercise may be beneficial for preserving health in pancreatic cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Clinic-Based Exercise Program in Patients with Pancreatic Cancer Undergoing Nonsurgical Treatment. Luo, H., Galvão, DA., Newton, RU., 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]

Exercise is feasible and can improve physical fitness and quality of life in patients undergoing treatment for pancreatic cancer, based on a review of 24 clinical trials.

However, the benefits of exercise may decrease as the disease progresses, indicating a need for more rigorous research to establish effective exercise protocols tailored for pancreatic cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of exercise on pancreatic cancer patients during treatment: a scoping review of the literature. Gupta, P., Hodgman, CF., Schadler, KL., et al.[2023]

A systematic review of 7 trials involving 201 patients with pancreatic cancer showed that exercise training is safe and feasible, with no reported adverse events and high retention rates (71% to 90%).

Exercise programs led to significant improvements in cancer-related fatigue, psychological distress, and physical function, suggesting that exercise may positively impact the health and well-being of patients with pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Medicine in the Management of Pancreatic Cancer: A Systematic Review. Luo, H., Galvão, DA., Newton, RU., et al.[2023]

Citations

1. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2023/1179848

Multimodal Exercise in Older Patients with Advanced ... All 5 patients increased or maintained lean mass (0.1%–4.4%) and 4 reduced fat mass (−0.4%–−8.6%). Improvements were observed in 4 or all 5 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12535004/

Digital and AI-assisted multimodal supportive care, combining ... The RELEVIUM-RCT investigates the efficacy of digital health support for individuals with advanced pancreatic cancer in conjunction with conventional treatments ...

3. npcf.us npcf.us/clinical-trials/pancfit-multimodal-exercise-during-preoperative-therapy-for-pancreatic-cancer/

PancFit: Multimodal Exercise During Preoperative Therapy ... The goal of this clinical research study is to learn if regular exercise and behavioral skills training can help to improve physical activity in patients with ...

4. mdpi.com mdpi.com/2072-6694/15/24/5899

Effects of Exercise Training on Patient-Specific Outcomes ... The results indicate that exercise is feasible and safe in pancreatic cancer patients. Furthermore, exercise was associated with improved quality of life, ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1365182X23018853

Personalized multimodal prehabilitation reduces ... This study investigates the effect of personalized multimodal prehabilitation on patients undergoing pancreatoduodenectomy.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10514993/

Feasibility of delivering supervised exercise training ... This case series provides preliminary evidence that concurrent exercise training during adjuvant therapy is safe, feasible and well tolerated.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2347562523001166

Exploring the feasibility of a combined exercise program for ... The findings suggest that a tailored 12-week exercise intervention is both feasible and safe for patients with advanced lung or pancreatic cancer.