Exercise Prehabilitation for Liver Cancer

Overseen By Ashley Morganti

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: Under 65, Unresectable cancer, others

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

Compensation: Varies

Number of Visits: Unknown

25 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to evaluate an exercise program for individuals with hepatobiliary cancer planning for surgery.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of exercise prehabilitation for liver cancer?

Research shows that exercise training, including aerobic and resistance exercises, can improve physical fitness and strength in cancer patients, which may help them better tolerate treatments and recover more effectively. Although specific data for liver cancer is limited, similar exercise interventions have been beneficial for patients with other types of cancer, such as breast cancer, by enhancing cardiovascular fitness and reducing treatment-related side effects. ^{1 2 3 4 5}

Is exercise safe for people undergoing cancer treatment?

Research shows that exercise, including aerobic and resistance training, is generally safe for people undergoing cancer treatment. Studies have found that exercise can be done safely with few adverse events (unwanted side effects) and can even provide health benefits like improved fitness and reduced risk factors for other diseases. ^{6 7 8 9 10}

How does exercise prehabilitation differ from other treatments for liver cancer?

Exercise prehabilitation is unique because it focuses on improving physical fitness before surgery, which can enhance recovery and reduce complications. Unlike traditional treatments that focus on the cancer itself, this approach aims to boost the patient's overall health and readiness for surgery. ^{10 11 12 13 14}

Research Team

Mohammed Al-Jumayli, MD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

This trial is for seniors aged 70 or older who have been diagnosed with bile duct cancer, liver cancer, or liver metastases and are fit enough to exercise. They must be planning to undergo surgery in at least 4 weeks and able to give consent.

Inclusion Criteria

I am able to care for myself and move around.

My liver cancer is operable and surgery is planned in over 4 weeks.

Able to sign consent

Exclusion Criteria

Does not meet inclusion criteria

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exercise Prehabilitation

Participants engage in an exercise program including resistance training and aerobic exercise until surgery

2-4 weeks

Telehealth sessions twice per week

Follow-up

Participants are monitored for safety and effectiveness after the exercise program

Up to 3 months

Treatment Details

Interventions

• Aerobic Training
• Resistance Training

Trial Overview The study is testing an exercise program that includes resistance and aerobic training for senior adults before they go through liver surgery due to hepatobiliary cancers.

Participant Groups

Group I: Tele Health Exercise Prehabilitation Experimental Treatment 2 Interventions

Participants will take part in an exercise program in which they will be encouraged to perform approximately 30 minutes of resistance training exercises approximately twice per week until they undergo surgery (Approximately 2-4 weeks). Participants will also be encouraged to perform moderate aerobic exercise such as brisk walking or using stationary aerobic equipment at least 3 times per week. Participants will wear a FitBit fitness watch to monitor aerobic exercise.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Findings from Research

In a study of 20 breast cancer patients undergoing neoadjuvant chemotherapy, those who participated in moderate-to-high intensity aerobic training showed a significant improvement in cardiopulmonary function, with a 13.3% increase in VO2peak compared to a decrease in the control group.

The aerobic training was found to be safe, with only one adverse event reported during the training sessions, and no significant differences in treatment-related side effects between the groups, indicating that it can be a beneficial adjunct therapy during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of aerobic training in operable breast cancer patients receiving neoadjuvant chemotherapy: a phase II randomized trial. Hornsby, WE., Douglas, PS., West, MJ., et al.[2022]

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]

Exercise training during neoadjuvant cancer treatment is safe and feasible, with adherence rates ranging from 66% to 96% across the four studies reviewed, indicating that patients can successfully participate in exercise programs during this challenging time.

While in-hospital exercise training has been shown to improve physical fitness in cancer patients, the effects on health-related quality of life (HRQoL) and other important clinical outcomes remain uncertain due to a lack of controlled trials in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise intervention in people with cancer undergoing neoadjuvant cancer treatment and surgery: A systematic review. Loughney, L., West, MA., Kemp, GJ., et al.[2022]

A 12-week exercise program involving 2 sessions per week of cardiovascular and strength training led to significant improvements in cardiovascular fitness (7% increase in predicted VO2peak) and strength (7-9% increase) in 40 out of 52 breast cancer patients, despite a median attendance of only 1.2 sessions per week.

While body composition and metabolic markers did not change, the study suggests that even lower-frequency exercise can be beneficial for fitness in recently diagnosed breast cancer patients, making it a practical option during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-frequency exercise training improves cardiovascular fitness and strength during treatment for breast cancer: a single-arm intervention study. Bell, KE., Pfeiffer, AG., Schmidt, S., et al.[2022]

This study will investigate the effects of supervised high-intensity aerobic and resistance exercise during neoadjuvant chemotherapy (NACT) on tumor size in 120 women with newly diagnosed breast cancer, aiming to determine if exercise can enhance tumor reduction and improve chemotherapy delivery.

The trial will measure various outcomes, including tumor size changes via MRI, physical fitness, and psychological well-being, over a 24-week period, potentially establishing exercise as a beneficial component of cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neo-train: study protocol and feasibility results for a two-arm randomized controlled trial investigating the effect of supervised exercise during neoadjuvant chemotherapy on tumour response in patients with breast cancer. Kjeldsted, E., Ammitzbøll, G., Jørgensen, LB., et al.[2023]

In a study involving 577 participants undergoing cancer treatment, exercise was found to be safe, with 20% of adverse events (AEs) reported by coaches and 28% by participants, mostly being minor musculoskeletal issues.

High-intensity exercise was associated with a higher likelihood of AEs compared to low-to-moderate exercise, but both forms of exercise are recommended for patients if there are no medical contraindications, as serious complications like lymphedema and PICC issues were low and not significantly different across exercise intensities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is it safe to exercise during oncological treatment? A study of adverse events during endurance and resistance training - data from the Phys-Can study. Henriksson, A., Johansson, B., Radu, C., et al.[2021]

Increasing the volume of aerobic exercise to 300 minutes per week significantly reduced the number of women classified as 'nonresponders' in a study of premenopausal women at elevated risk for breast cancer, with only 5.6% being nonresponders compared to 23.5% in the low-dose group.

Both exercise groups (150 and 300 minutes per week) showed a high percentage of women (87.2% and 94.9%, respectively) experiencing a reduction in predicted cancer mortality risk, indicating that even 150 minutes of exercise per week is effective in lowering this risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased Duration of Exercise Decreases Rate of Nonresponse to Exercise but May Not Decrease Risk for Cancer Mortality. Lin, D., Potiaumpai, M., Schmitz, K., et al.[2023]

Resistance exercise training significantly benefits the musculoskeletal system and helps prevent conditions like osteoporosis, sarcopenia, and lower-back pain, making it essential for maintaining functional abilities.

Just two 15- to 20-minute sessions of resistance training per week can effectively improve various health risk factors, including insulin resistance and blood pressure, suggesting it should be a key focus in public health promotion alongside aerobic exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential health-related benefits of resistance training. Winett, RA., Carpinelli, RN.[2022]

Aerobic training was found to be safe for women with metastatic breast cancer, with only 3% of participants lost to follow-up, but the overall attendance rate was lower than the predefined feasibility target, indicating challenges in implementation.

Despite feasibility issues, 42% of patients who completed the aerobic training showed improvements in their peak oxygen consumption (VO2peak) and functional capacity, suggesting potential benefits for select individuals that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, safety, and efficacy of aerobic training in pretreated patients with metastatic breast cancer: A randomized controlled trial. Scott, JM., Iyengar, NM., Nilsen, TS., et al.[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 for patients awaiting orthotopic liver transplantation (OLT) significantly improve physical fitness measures such as VO2 peak, walking distance, and hand grip strength, indicating enhanced aerobic capacity and quality of life.

The review included 1,094 patients and found that prehabilitation is generally safe, with no serious adverse events reported, although adherence rates varied and larger trials are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Effects, Safety and Feasibility of Prehabilitation in Patients Awaiting Orthotopic Liver Transplantation, a Systematic Review. Jetten, WD., Hogenbirk, RNM., Van Meeteren, NLU., et al.[2022]

Exercise prehabilitation is crucial for preparing cancer patients for treatments like surgery, with evidence supporting its role in improving fitness and strength, particularly through supervised moderate-intensity aerobic and resistance exercises.

Multimodal prehabilitation programs that include exercise, nutritional support, and psychological interventions are becoming standard practice, enhancing patient outcomes and adherence to treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Exercise Before Cancer Treatment. Denehy, L., Edbrooke, L.[2022]

This systematic review aims to evaluate the benefits and harms of prehabilitation programs, primarily focused on physical exercise, for cancer patients compared to standard care, highlighting the potential for improved clinical outcomes such as aerobic capacity and reduced postoperative complications.

The review will utilize rigorous methods, including independent screening of studies and quality assessments, to ensure reliable results that can guide healthcare providers and patients in making informed decisions about prehabilitation in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation programs for cancer patients: a systematic review of randomized controlled trials (protocol). Meneses-Echávez, JF., Loaiza-Betancur, AF., Díaz-López, V., et al.[2023]

A 4-week supervised exercise program significantly improved preoperative fitness in patients undergoing liver resection for colorectal liver metastasis, as evidenced by increased oxygen uptake at the anaerobic threshold and peak exercise levels.

Participants in the prehabilitation group also reported enhanced quality of life, with notable improvements in overall SF-36 scores, suggesting that preoperative exercise can positively influence both physical fitness and mental well-being before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of prehabilitation before planned liver resection. Dunne, DF., Jack, S., Jones, RP., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of aerobic training in operable breast cancer patients receiving neoadjuvant chemotherapy: a phase II randomized trial. [2022]

2. 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]

3. England pubmed.ncbi.nlm.nih.gov

Exercise intervention in people with cancer undergoing neoadjuvant cancer treatment and surgery: A systematic review. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Low-frequency exercise training improves cardiovascular fitness and strength during treatment for breast cancer: a single-arm intervention study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Neo-train: study protocol and feasibility results for a two-arm randomized controlled trial investigating the effect of supervised exercise during neoadjuvant chemotherapy on tumour response in patients with breast cancer. [2023]

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

Is it safe to exercise during oncological treatment? A study of adverse events during endurance and resistance training - data from the Phys-Can study. [2021]

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

Increased Duration of Exercise Decreases Rate of Nonresponse to Exercise but May Not Decrease Risk for Cancer Mortality. [2023]

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

Potential health-related benefits of resistance training. [2022]

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

Feasibility, safety, and efficacy of aerobic training in pretreated patients with metastatic breast cancer: A randomized controlled trial. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Prehabilitation programs for individuals with cancer: a systematic review of randomized-controlled trials. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Physical Effects, Safety and Feasibility of Prehabilitation in Patients Awaiting Orthotopic Liver Transplantation, a Systematic Review. [2022]

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

The Role of Exercise Before Cancer Treatment. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Prehabilitation programs for cancer patients: a systematic review of randomized controlled trials (protocol). [2023]

14. England pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of prehabilitation before planned liver resection. [2022]