148 Participants NeededMy employer runs this trial

Prehabilitation for Cancer Surgery

DC
SW
Overseen ByShondra Word
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: The Methodist Hospital Research Institute
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Comprehensive Multimodal Prehabilitation (CMMP) to determine its effectiveness in helping individuals who are frail or nearly frail and have certain cancers—such as pancreatic, ovarian, kidney, or bladder cancer—prepare for major surgery. The trial examines whether the program alone or combined with other pre-surgery treatments (neoadjuvant therapy) can improve surgical outcomes. The program includes nutrition counseling, exercise, and breathing exercises to enhance patients' strength and readiness for surgery. Candidates for this trial include those diagnosed with one of these cancers, considered frail, and able to manage the program's exercises and dietary changes. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant findings.

Do I have to stop taking my current medications for the trial?

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 to get specific guidance based on your situation.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that comprehensive multimodal prehabilitation (CMMP) is generally safe for patients. Studies have found that it can reduce the risk of complications after surgeries, such as those for lung and colorectal cancer. Specifically, patients who used CMMP experienced fewer issues in the 30 days following lung cancer surgery.

Most participants handle the program well, which includes activities like exercise, nutrition advice, and breathing exercises. However, one study found that CMMP did not significantly benefit frail patients more than other rehabilitation methods. This suggests that while CMMP is safe, its benefits may vary based on a person's health. Overall, evidence suggests CMMP is a safe option for improving surgery outcomes.12345

Why are researchers excited about this trial?

Most treatments for cancer focus on surgery, chemotherapy, or radiation after diagnosis. However, the Comprehensive Multimodal Prehabilitation (CMMP) approach is unique because it prepares patients before major cancer surgery. This method combines motivational interviewing, nutritional counseling with protein supplements, inspiratory muscle training, and physical exercises like aerobic and strength training. Researchers are excited because this proactive strategy aims to boost patients’ physical and mental readiness, potentially improving recovery and outcomes post-surgery. By targeting patients' overall health before surgery, CMMP may offer a valuable new angle in cancer care.

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

This trial will evaluate the effectiveness of Comprehensive Multimodal Prehabilitation (CMMP) for patients undergoing major cancer surgery. Studies have shown that preparing for surgery with a combination of exercises and nutrition support can enhance recovery. Research indicates this approach reduces complications and improves physical function after surgery, particularly for cancers like lung and colorectal cancer. It has also been found to lower anxiety levels in patients. However, its effectiveness can vary depending on the type of surgery and the patient group. Overall, it appears to be a promising method for preparing for major cancer surgeries. Participants in this trial will receive the CMMP intervention, with some also receiving planned neoadjuvant therapy.12456

Who Is on the Research Team?

NE

Nestor Esnaola, M.D.

Principal Investigator

Houston Methodist Neal Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults (18+) who are pre-frail or frail and have pancreatic, bile duct, ovarian, kidney, or bladder cancer. Participants must be able to eat by mouth, use a smartphone, understand English, and be scheduled for major cancer surgery. People needing more than a cane to walk or with serious heart issues can't join.

Inclusion Criteria

I am 18 years old or older.
Willing and able to consume specified protein supplements
Signed informed consent form
See 13 more

Exclusion Criteria

I need a mobility device other than a cane to get around.
Planned receipt of investigational therapy/treatment during the trial treatment
I am unable to eat by mouth.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants receive comprehensive multimodal prehabilitation (CMMP) alone or with planned neoadjuvant therapy (NAT) for at least 3 weeks prior to elective major cancer surgery

3-4 weeks
Weekly assessments (in-person or virtual)

Preoperative Reassessment

Evaluation of the impact of CMMP on intermediate endpoints such as nutritional status, body composition, and functional capacity

1 week
1 visit (in-person)

Surgery and Postoperative Assessment

Participants undergo elective major cancer surgery and are assessed for postoperative morbidity and healthcare utilization

Up to 90 days postoperatively
Multiple visits (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and overall survival up to 2 years after surgery

2 years
Periodic assessments (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Comprehensive Multimodal Prehabilitation

Trial Overview

The study looks at whether a comprehensive health program (CMMP) before surgery—alone or combined with standard pre-surgery treatments—helps people prepare for major cancer operations. The trial has two groups but isn't randomized.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Planned neoadjuvant therapy/CMMP interventionExperimental Treatment1 Intervention
Group II: CMMP interventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials
299
Recruited
82,500+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41872610/

The effectiveness of multimodal prehabilitation on ...

Conclusion: In conclusion, this meta-analysis suggests that multimodal prehabilitation is a promising strategy for modestly improving functional ...

Comprehensive Multimodal Prehabilitation Alone or With ...

Additional secondary endpoints will include postoperative morbidity/healthcare utilization and 2-year overall survival (OS) and disease-free ...

The Effects of Multimodal Prehabilitation on Postoperative ...

Multimodal prehabilitation improves functional recovery and reduces overall complications in colorectal cancer surgery, though its effect on ...

The effect of multimodal prehabilitation on postoperative ...

Multimodal prehabilitation significantly reduced overall and major postoperative 30-day complications in lung cancer surgery. It also contributed to reducing ...

Effects of multimodal prehabilitation on surgery outcomes

Multimodal prehabilitation may improve surgical outcomes in selected populations, but its real-world effectiveness remains unclear. The aim of this study ...

The effect of multimodal prehabilitation on postoperative ...

Multimodal prehabilitation significantly reduced overall and major postoperative 30-day complications in lung cancer surgery. It also contributed to reducing ...