Exercise and Nutritional Counseling for Pancreatic Cancer

Overseen By Rachel Neuhold, PT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Unsafe to exercise, Whey allergy, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether exercise and nutritional counseling can benefit individuals with pancreatic or related cancers before surgery. Participants will be randomly assigned to one of two exercise programs, with or without personalized resistance training, to assess the feasibility and benefits of this setup. The goal is to discover if just 2-3 weeks of this "prehabilitation" can enhance physical function or quality of life. Eligible participants should have pancreatic cancer, be preparing for surgery, and be capable of participating in home-based exercise programs. As an unphased trial, this study provides a unique opportunity to contribute to research that could improve pre-surgery care and outcomes.

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 study team or your doctor.

What prior data suggests that this exercise and nutritional counseling intervention is safe for patients undergoing pancreaticoduodenectomy?

Research has shown that exercise is generally safe for people with pancreatic cancer. Studies indicate that both more intense and regular exercise plans are well-tolerated by patients and do not cause major safety issues. Exercise is linked to improved physical fitness and muscle strength in these patients.

One study found that exercise does not worsen cancer-related symptoms. Another study confirmed that exercise is possible and safe during treatment for pancreatic cancer. These findings suggest that both more intense and regular exercise routines are likely safe options for individuals with this type of cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Exercise and Nutritional Counseling approach for pancreatic cancer because it offers a holistic way to support patients beyond traditional chemotherapy and surgery. Unlike standard treatments, which focus primarily on attacking the cancer directly, this approach emphasizes enhancing patients' overall physical fitness and nutrition, potentially improving their quality of life and resilience during treatment. The Enhanced Exercise Group introduces a personalized fitness routine, including cardiovascular and resistance training, tailored to individual capabilities, which could help patients maintain strength and energy levels. Meanwhile, nutritional counseling aims to provide patients with the dietary tools necessary to support their health during the taxing cancer treatment process. This dual focus on exercise and nutrition makes this approach uniquely comprehensive in supporting patients' overall well-being.

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

This trial will compare Enhanced Exercise with Standard Exercise for people with pancreatic cancer. Research has shown that exercise is safe and feasible for this population. Studies have found that exercise strengthens muscles in both the upper and lower body. Even a short period of exercise before surgery might enhance physical abilities. Additionally, being active is associated with a better quality of life and a reduced risk of cancer. These benefits make exercise a promising component of cancer treatment plans. ^{1 2 4 6 7}

Who Is on the Research Team?

Elizabeth Hile, PhD, PT

Principal Investigator

Faculty

Are You a Good Fit for This Trial?

This trial is for individuals over 30 with suspected pancreatic or related tumors who are fit to exercise and can understand English. They must be able to move without help, agree to random assignment in home-based exercise programs, and use protein supplements if needed. Those already on a substantial exercise or protein regimen may only join the observational part of the study.

Inclusion Criteria

I am willing to follow a random home exercise program and take protein if told to.

I am approved for surgery on a pancreatic-related tumor and cleared for exercise by the clinic team.

I can walk around my house without help.

Exclusion Criteria

You cannot be allergic to whey protein, and you should not have any trouble with walking and strength tests.

I am in a regular strength or protein program, so I can only join the study's observational part.

I am not excluded from the study due to safety concerns related to exercise.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Prehabilitation

Participants undergo a home-based exercise program with dietary counseling for 2-3 weeks prior to surgery

2-3 weeks

Daily exercise sessions, follow-up phone calls

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

First post-operative visit

Long-term Follow-up

Participants' retention, adherence, and quality of life are assessed over a 2-year period

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Exercise
• Nutritional Counseling
• Standard Exercise

Trial Overview Participants will receive dietary counseling and engage in home exercises at high frequency before surgery for pancreatic cancer. The study tests two types of pre-surgery 'prehabilitation': standard vs enhanced (with resistance training) exercises, aiming to improve physical function and quality of life within 2-3 weeks.

How Is the Trial Designed?

Group I: Standard Exercise Group Experimental Treatment 2 Interventions

Patients receive a single instruction session with a physical therapist, for training in moderate intensity (using Rate of Perceived Exertion) exercise including cardiovascular endurance, flexibility, and AROM of upper and lower body. If no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs.

Group II: Enhanced Exercise Group Experimental Treatment 2 Interventions

Patients receive a single instruction session with a physical therapist, for training in moderate intensity (using Rate of Perceived Exertion) exercise including cardiovascular endurance, flexibility, and resistance exercise for upper and lower body. If no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs.

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10741570/

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 ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S104084282500349X

Impact of exercise in patients with pancreatic cancer across ... Data on patient-reported outcomes showed that exercise did not increased their physical function, QoL or hepatobiliary cancer-specific symptoms.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12355156/

Effects of exercise therapy in patients with pancreatic cancer The findings of this study indicate that exercise therapy for pancreatic cancer patients effectively increases muscle strength in the upper and lower limbs ...

4. mdpi.com mdpi.com/2072-6694/17/4/630

Exercise Guidelines in Pancreatic Cancer Based on the ... Physical activity has been associated with decreased cancer incidence and improved outcomes, specifically concerning quality of life [11,12,13,14,15]. In ...

5. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-020-07733-0

Exercise efficacy and prescription during treatment for ... This study aims to summarise the published literature on exercise studies conducted in patients with pancreatic cancer undergoing treatment

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4896495/

Physical activity and pancreatic cancer risk: a systematic ... Physical activity has been associated with a lower risk of pancreatic cancer in several studies, but the overall epidemiologic evidence is not consistent.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666142X25001031

Effects of exercise therapy in patients with pancreatic cancer The results of this study showed that exercise interventions were effective in improving upper and lower limb muscle strength. In addition, improvements in ...