Prehabilitation Exercise for Ovarian Cancer

Overseen By Scott Grandy, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Unstable cardiac, respiratory disease, others

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

Compensation: Varies

Number of Visits: 4

108 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a pre-surgery exercise program, the Prehabilitation Exercise Intervention, can aid women with advanced ovarian cancer in recovering better post-surgery. The main goal is to determine if exercising before surgery can reduce frailty and improve recovery and chemotherapy outcomes. Women with stage III or IV ovarian cancer, scheduled for surgery, and with at least four weeks before their surgery date may be suitable candidates. The researchers hope this exercise intervention could improve survival chances. As an unphased trial, participants can contribute to pioneering research that may enhance recovery strategies for future patients.

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 your doctor or the trial coordinators.

What prior data suggests that this prehabilitation exercise is safe for patients with advanced ovarian cancer?

Research has shown that prehabilitation exercises are generally safe for patients. Studies have found that these exercises can enhance recovery after surgery. For example, over 77% of patients who engaged in prehabilitation improved their walking ability before surgery, indicating that the exercises are well-tolerated and beneficial.

Importantly, no major reports of serious side effects from prehabilitation exercises have emerged. These exercises typically include simple activities like walking or chair exercises, making them accessible for most people.

Overall, prehabilitation exercises appear to be a safe choice for those preparing for surgery, potentially improving recovery without adding risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the prehabilitation exercise intervention for ovarian cancer because it offers a proactive approach to patient care. Unlike traditional treatments that focus on addressing cancer directly through surgery, chemotherapy, or radiation, this exercise-based intervention aims to improve patients' physical fitness before undergoing these intensive therapies. By enhancing strength and endurance through a circuit-based exercise program, the treatment has the potential to help patients better tolerate cancer treatments, recover more quickly, and improve overall quality of life. This shift towards improving patient resilience and readiness represents a promising complementary strategy in the fight against ovarian cancer.

What evidence suggests that prehabilitation exercise is effective for improving outcomes in advanced ovarian cancer?

Research shows that exercising before surgery, known as prehabilitation, can help women with ovarian cancer recover better after their operations. In this trial, participants will engage in a circuit-based prehabilitation exercise intervention. Studies have found that increased activity before surgery links to fewer complications and quicker recovery. One study found that prehabilitation shortened hospital stays for these patients. Another study showed that over 77% of patients who did prehabilitation improved their ability to walk before surgery. These findings suggest that exercise could effectively enhance surgical outcomes for women with advanced ovarian cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Scott Grandy, MD

Principal Investigator

Nova Scotia Health

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 with stage III or IV ovarian cancer, who are approved by their oncologist to join. They must be scheduled for cytoreductive surgery with at least a 4-week gap before the operation and able to attend exercise sessions. Those with unstable heart/lung disease, significant cognitive issues, or post-surgery status cannot participate.

Inclusion Criteria

My surgery is scheduled at least 4 weeks after joining the study.

Have oncologist approval

Be fluent in English

Exclusion Criteria

I can understand and follow instructions.

I do not have any heart, lung, or other serious health issues that make exercising unsafe for me.

I have completed my surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation Exercise

Participants undergo a 4+ week exercise program to reduce frailty and improve recovery before surgery

4+ weeks

3 sessions per week

Surgery

Participants undergo surgery for ovarian cancer, with outcomes assessed post-surgery

Immediate

Chemotherapy

Participants receive chemotherapy treatment, with completion rates assessed at the end of each cycle

18 weeks (6 cycles of 3 weeks each)

Follow-up

Participants are monitored for surgical outcomes, frailty, and quality of life changes post-surgery

3 months

Regular assessments at 1-month and 3-months post-surgery

What Are the Treatments Tested in This Trial?

Interventions

• Prehabilitation Exercise Intervention

Trial Overview The study tests if a prehabilitation exercise program (like walking, chair exercises) can reduce frailty in patients awaiting surgery for advanced ovarian cancer. It aims to see if this improves recovery after surgery and affects chemotherapy treatment plans.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Circuit-based prehabilitation exercise intervention

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Dalhousie University

Collaborator

Trials

177

Recruited

402,000+

Published Research Related to This Trial

Prehabilitation, which includes exercise, nutrition, and psychological support, aims to improve patients' health before surgery, potentially reducing stress and enhancing recovery.

Addressing moderate-to-severe undernutrition before gynecological oncology surgery has been shown to lower the risk of postoperative complications and improve overall survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining prehabilitation with enhanced recovery programs in gynecological surgery. Falandry, C., Fauvet, R., Alfonsi, P., et al.[2022]

In a pilot study of 29 advanced ovarian cancer patients, those who participated in a prehabilitation program showed significantly improved nutritional levels both before and after surgery compared to the control group.

Patients in the prehabilitation group experienced fewer intraoperative complications and required fewer blood transfusions, suggesting that prehabilitation may enhance surgical outcomes and recovery, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of prehabilitation during neoadjuvant chemotherapy and interval cytoreductive surgery on ovarian cancer patients: a pilot study. Miralpeix, E., Sole-Sedeno, JM., Rodriguez-Cosmen, C., 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]

Multimodal prehabilitation programs, which include physical exercise, nutrition, and psychological support, significantly reduced hospital stay and time to chemotherapy for patients with ovarian cancer, based on a review of seven studies involving 580 patients.

While prehabilitation was associated with weight loss in patients with endometrial and cervical cancer, it did not significantly impact surgical complications or mortality, and no adverse events were reported, indicating a generally safe approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation to Improve Outcomes of Patients with Gynaecological Cancer: A New Window of Opportunity? Dhanis, J., Keidan, N., Blake, D., et al.[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]

This study aims to evaluate the effectiveness of a multimodal prehabilitation program, which includes exercise, nutrition, and psychological support, in reducing post-operative complications for 146 women undergoing cytoreductive surgery for advanced ovarian cancer.

The trial will compare outcomes between the prehabilitation group and standard care, with the primary focus on post-operative complications measured by the Comprehensive Complication Index, and results are expected to be available after December 2024.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multimodal prehabilitation program for the reduction of post-operative complications after surgery in advanced ovarian cancer under an ERAS pathway: a randomized multicenter trial (SOPHIE). Díaz-Feijoo, B., Agusti, 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]

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]

In a study of 67 oesophageal cancer patients, a personalized pre-operative exercise program helped maintain and even improve cardiorespiratory fitness during neoadjuvant chemotherapy, with significant increases noted just before surgery.

Higher adherence to the exercise program and greater volumes of physical activity were linked to a lower risk of post-operative pneumonia, emphasizing the importance of consistent exercise during prehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Pre-operative Exercise and the Response to Prehabilitation in Oesophageal Cancer Patients. Halliday, LJ., Doganay, E., Wynter-Blyth, V., et al.[2023]

Citations

1. 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.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090825825008960

Fit4Surgery: A pilot randomized controlled trial to assess ... For patients with ovarian cancer, increased pre-operative physical activity has been linked to fewer postoperative complications, and faster time to recovery, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9351657/

Prehabilitation to Improve Outcomes of Patients with ... The limited evidence shows that prehabilitation may reduce length of hospital stay for ovarian cancer patients, and may result in significant ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05364879

NCT05364879 | Prehabilitation for Ovarian Cancer Patients This study will provide important information about the ability of prehabilitation exercise to improve surgical and treatment outcomes in women with advanced ...

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

Optimizing prehabilitation in gynecologic malignancies Over 77 % of patients in the intervention group showed an improved walking ability before the abdominal surgery compared to a decrease in the control group.

6. 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 Frailty and loss of muscle mass are correlated with lower cancer survival in patients 65 and older.

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

Feasibility and Effects of Implementing Multimodal ... This study evaluated the feasibility and effects of two different multimodal prehabilitation programs implemented before cytoreductive surgery in ovarian cancer ...