Prehabilitation for Ovarian and Pancreatic Cancer

Overseen By Mariam AlHilli, MD

Age: 65+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Life expectancy <3 months, Physical immobility, Severe cardiopulmonary disease, Malignant bowel obstruction, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

22 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special program of exercise, nutrition, and support, known as Prehabilitation, can help individuals maintain healthy habits while preparing for cancer surgery. The focus is on patients with advanced ovarian, pancreatic, esophageal, or bladder cancer who are receiving chemotherapy before surgery. One group will receive personalized exercise plans, high-protein drinks, and access to support services, while the other will receive standard care. Suitable candidates have been diagnosed with one of these cancers and are already undergoing chemotherapy. As a Phase 1 trial, the research focuses on understanding how the treatment works in participants, offering them the opportunity to be among the first to benefit from this innovative approach.

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. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this prehabilitation intervention is safe for cancer patients?

Research has shown that prehabilitation, which includes exercise and nutrition support, is generally well-received by patients with ovarian cancer. In one study, patients who participated in a prehabilitation program demonstrated better nutritional health, indicating that the program is safe and manageable for them. Another study focused on older patients with ovarian or pancreatic cancer and found that the prehabilitation program was safe and practical, meaning it didn’t cause any major problems for the participants.

These findings suggest that prehabilitation is a promising approach with a good safety record. However, it's important to remember that this trial remains in its early stages. The treatment’s safety is still under careful study, but the current evidence is encouraging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a comprehensive approach called "prehabilitation" for patients with ovarian and pancreatic cancer. Unlike standard treatments that often focus solely on the direct medical aspects of cancer care, this approach combines exercise, nutrition, and supportive care to potentially enhance patients' overall health and resilience before undergoing cancer treatment. The trial's unique features include personalized exercise programs using the SmartGym ecosystem, targeted nutritional supplements to ensure optimal protein intake, and free access to mind-body support services. This holistic strategy aims to improve patients' physical and mental well-being, potentially leading to better treatment outcomes and quality of life.

What evidence suggests that prehabilitation might be an effective treatment for ovarian and pancreatic cancer?

Research has shown that prehabilitation, which participants in this trial may receive, can benefit patients with ovarian and pancreatic cancer. Studies have found that it improves physical health, body strength, and emotional well-being. For instance, prehabilitation reduces complications and the need for extra care after hospital discharge, easing recovery. It remains effective even during chemotherapy. These findings suggest that prehabilitation could prepare patients for surgery and aid in smoother recovery. ^{1 2 4 5 6}

Who Is on the Research Team?

Mariam AlHilli, MD

Principal Investigator

Cleveland Clinic Foundation, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with specific cancers: ovarian tumors, ovarian cancer, and pancreatic adenocarcinoma. They are about to start chemotherapy and will later undergo surgery for their cancer. The key requirement is a willingness to follow an exercise and nutrition program before the surgery.

Inclusion Criteria

I am 65 years old or older.

I am receiving chemotherapy before surgery for pancreatic cancer.

I have advanced ovarian, fallopian tube, or peritoneal cancer and am receiving chemotherapy before surgery.

Exclusion Criteria

Patients with any other comorbidity or condition, which, in the opinion of the enrolling investigator, would place the patient at unnecessarily higher greater risk or burden, or participating in the study would not be in the best interests of the patient.

Life expectancy less than 3 months in the opinion of the treating physician

I am able to understand and agree to the study's procedures and risks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants undergo a multimodal prehabilitation intervention including exercise, nutrition, and supportive care during chemotherapy

6 weeks

Weekly visits for exercise and nutrition assessment

Chemotherapy

Participants receive neoadjuvant chemotherapy while engaging in prehabilitation activities

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Prehabilitation

Trial Overview The study tests if a 'prehabilitation' program (a combination of exercise and nutrition) can be followed by patients during their chemotherapy treatment period in preparation for upcoming cancer surgery.

How Is the Trial Designed?

Group I: Intervention - Arm 1 Experimental Treatment 1 Intervention

Exercise Intervention: Participants will be referred to Langston Hughes Community Center and work with exercise physiologists who will utilize our SmartGym ecosystem in providing exercise assessments, prescriptions, and training. Nitrition Intervention: Participants in the intervention group will be provided with 1-2 bottles of high protein oral nutritional supplements daily (ONS) to ensure that protein needs are met daily. There will be two options of ONS to choose from: one option a high calorie, high protein supplement, and the other option a low fat/low sugar, high protein supplement. Supportive care/Mind-body intervention: Participants will have access to Taussig Cancer Institute Patient Support services that are offered for free.

Group II: Control - Arm 2 Active Control 1 Intervention

Exercise: Standard of care. Level of activity will be reported and monitored at each visit through study coordinator assessment and patient interview. Nutrition: Participants will be referred to dietitian and will be seen for a baseline evaluation, as needed throughout treatment and post treatment. A full nutrition assessment will be performed, and malnutrition diagnosis will be documented. When no malnutrition is identified participants will be provided general nutrition counseling related to their cancer type, cancer treatment, and recommendations for symptom management as needed. Those participants identified to be malnourished to any degree will receive personalized medical nutrition therapy including nutrition interventions to improve caloric intake. Supportive care/Mind-body intervention: Per standard of care, participants will be offered support services from Taussig Cancer Institute program.

Prehabilitation is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Prehabilitation for:

• Preparation for liver transplantation in patients with cirrhosis

Approved in United States as Prehabilitation for:

• Preparation for liver transplantation in patients with cirrhosis

Approved in Canada as Prehabilitation for:

• Preparation for liver transplantation in patients with cirrhosis

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Published Research Related to This Trial

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]

This scoping review analyzed 24 studies on multimodal prehabilitation for gynaecological cancer patients, highlighting the need for tailored programs to prepare them physically and psychologically for extensive surgeries and treatments.

Key factors influencing patient engagement in prehabilitation include the role of healthcare professionals, patient perceptions of acceptability, motivation, prioritization of prehabilitation, and access to these programs, indicating that a standardized approach is still needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Considerations for multimodal prehabilitation in women with gynaecological cancers: a scoping review using realist principles. Saggu, RK., Barlow, P., Butler, J., et al.[2022]

The study aimed to implement a prehabilitation program for high-risk patients undergoing major abdominal cancer surgery, but it did not meet its targets for recruitment, retention, and adherence, highlighting challenges in engaging patients in such programs.

Out of 238 screened patients, only 50 participated, and while retention was relatively high at 84%, adherence to the exercise regimen was low, with only 28% of participants reporting compliance above 70%, indicating a need for better strategies to encourage participation in prehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation in high-risk patients scheduled for major abdominal cancer surgery: a feasibility study. Waterland, JL., Ismail, H., Granger, CL., et al.[2022]

Patients undergoing complex abdominal cancer surgery are generally positive about prehabilitation and see its potential benefits, but they prefer it to be tailored to their individual needs and circumstances.

Support and supervision for prehabilitation must align with patients' preferences and values to be effective, highlighting the importance of patient involvement in designing these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What matters to you? An investigation of patients' perspectives on and acceptability of prehabilitation in major cancer surgery. Beck, A., Vind Thaysen, H., Hasselholt Soegaard, C., et al.[2021]

Prehabilitation, which includes exercise, nutrition, and psychosocial support, significantly reduced hospital length of stay by an average of 1.78 days for patients undergoing cancer surgery, based on a meta-analysis of 15 studies involving various cancer types.

However, prehabilitation did not show any significant impact on functional capacity, postoperative complications, or mortality rates, suggesting its primary benefit lies in speeding up recovery rather than improving overall surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Prehabilitation on Patient Outcomes in Hepatobiliary, Colorectal, and Upper Gastrointestinal Cancer Surgery: A PRISMA-Accordant Meta-analysis. Lambert, JE., Hayes, LD., Keegan, TJ., et al.[2023]

A 4-week multimodal prehabilitation program using blood flow restriction training and sports nutrition supplements significantly improved physical function and lean mass in 24 abdominal cancer patients awaiting surgery, as evidenced by various physical performance tests (p < 0.05).

The program led to an increase in total body lean mass by 0.73 kg and a decrease in body fat, demonstrating its effectiveness in enhancing the physical capacity of patients before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation program composed of blood flow restriction training and sports nutrition improves physical functions in abdominal cancer patients awaiting surgery. Wooten, SV., Fleming, RYD., Wolf, JS., et al.[2022]

A multimodal prehabilitation program for patients with advanced ovarian cancer (AOC) showed high feasibility with 80% overall adherence, leading to significantly shorter hospital stays (5 days vs. 7 days) compared to a control group.

Patients in the prehabilitation cohort also started chemotherapy sooner (25 days vs. 35 days), indicating potential benefits in recovery time without major adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Multimodal Prehabilitation Programme in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer: A Pilot Study. Diaz-Feijoo, B., Agusti-Garcia, N., Sebio, R., et al.[2022]

Enhanced Recovery After Surgery (ERAS) protocols have improved outcomes for gynecology-oncology patients, but they do not address critical preoperative issues like comorbidities, malnutrition, and mental health, which can negatively impact recovery.

Prehabilitation, a multimodal program that includes exercise, nutrition, and psychological support, can effectively prepare gynecology-oncology patients for surgery by addressing these modifiable risk factors, potentially leading to better postoperative recovery and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advocating for prehabilitation for patients undergoing gynecology-oncology surgery. Elsherbini, N., Carli, F.[2022]

In a study of 92 patients with oesophageal cancer, those who participated in a multimodal prehabilitation program had a significantly higher rate of completing their neoadjuvant chemotherapy compared to those who did not receive prehabilitation (p = 0.029).

The results suggest that prehabilitation may enhance patients' tolerance to chemotherapy, indicating a potential benefit for optimizing cancer treatment, although further research is needed to explore its long-term effects on cancer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized Prehabilitation Improves Tolerance to Chemotherapy in Patients with Oesophageal Cancer. Christodoulidis, G., Halliday, LJ., Samara, A., et al.[2023]

Citations

1. lidsen.com lidsen.com/journals/geriatrics/geriatrics-09-01-304

Improving Outcomes in Elderly Patients with Ovarian and ... These findings suggest that prehabilitation can optimize healthcare efficiency by reducing complications and the need for post-discharge care, warranting ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11640205/

Prehabilitation—A Simple Approach for Complex Patients This study aims to assess the effectiveness of preoperative prehabilitation on postoperative outcomes in patients with ovarian cancer. We ...

3. 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.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1048891X25009776

Multimodal prehabilitation improves functional capacity in ... This study showed that multimodal prehabilitation significantly improves physical function, body composition, and emotional well-being. To our ...

5. mdpi.com mdpi.com/2072-6694/17/9/1393

Feasibility and Effects of Implementing Multimodal ... These findings suggest that prehabilitation is both feasible and effective for patients with ovarian cancer, even during neoadjuvant chemotherapy. Abstract.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0748798324007960

Optimizing prehabilitation in gynecologic malignancies In a retrospective observational study conducted on 29 advanced ovarian cancer patients, multimodal prehabilitation resulted in an improvement of nutritional ...