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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to see whether participants who are assigned to a multimodal prehabilitation intervention during chemotherapy are able to adhere with exercise and nutrition program to prepare for their cancer 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. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Prehabilitation, Multidisciplinary Prehabilitation, Preoperative Optimization, Pre-LT Rehabilitation for ovarian and pancreatic cancer?

Research shows that prehabilitation, which includes exercise and nutrition strategies, can improve physical fitness and recovery in patients undergoing major surgeries, such as those for abdominal and gastrointestinal cancers. This suggests potential benefits for ovarian and pancreatic cancer patients as well. ^{1 2 3 4 5}

Is prehabilitation safe for humans?

Prehabilitation, which includes exercise, nutrition, and psychological support before surgery, has been shown to be safe and beneficial in improving outcomes for patients undergoing various types of major surgeries, including colorectal and thoracic surgeries. It is generally considered safe for humans, as it aims to enhance physical and mental strength before surgery. ^{1 3 6 7 8}

How is the prehabilitation treatment different from other treatments for ovarian and pancreatic cancer?

Prehabilitation is unique because it focuses on preparing patients physically and mentally before surgery through a combination of exercise, nutrition, and psychological support. Unlike standard treatments that primarily address the cancer itself, prehabilitation aims to improve overall fitness and resilience, potentially leading to better recovery and outcomes after surgery. ^{1 3 4 8 9}

Research Team

Mariam AlHilli, MD

Principal Investigator

Cleveland Clinic Foundation, Case Comprehensive Cancer Center

Eligibility Criteria

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

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

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.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of a Multimodal Prehabilitation Programme in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer: A Pilot Study. [2022]

2. United States 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. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Prehabilitation prior to surgery for pancreatic cancer: A systematic review. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Personalized Prehabilitation Improves Tolerance to Chemotherapy in Patients with Oesophageal Cancer. [2023]

5. England 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. [2022]

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

Prehabilitation in high-risk patients scheduled for major abdominal cancer surgery: a feasibility study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

What matters to you? An investigation of patients' perspectives on and acceptability of prehabilitation in major cancer surgery. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Advocating for prehabilitation for patients undergoing gynecology-oncology surgery. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Considerations for multimodal prehabilitation in women with gynaecological cancers: a scoping review using realist principles. [2022]