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

Trial Summary

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 data supports the effectiveness of the treatment Prehabilitation Exercise Intervention for ovarian cancer?

Prehabilitation programs, which include exercise before surgery, have shown promise in improving outcomes for cancer patients, such as those with oesophageal cancer, by enhancing fitness and reducing complications. Although specific data for ovarian cancer is limited, similar programs have been effective in other types of cancer, suggesting potential benefits. ^{1 2 3 4 5}

Is prehabilitation exercise safe for humans?

Prehabilitation exercise programs, which include physical exercise, nutrition, and psychological support, have been studied in patients with various types of cancer, including ovarian cancer. These programs have not reported any adverse events, suggesting they are generally safe for humans. ^{1 2 4 6 7}

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

Prehabilitation exercise treatment is unique because it focuses on preparing patients physically, nutritionally, and psychologically before surgery to improve recovery and reduce complications, unlike standard treatments that primarily focus on surgery and chemotherapy after diagnosis. ^{1 3 7 8 9}

What is the purpose of this trial?

Individuals with ovarian cancer have very poor survival rates. This is because the cancer is not usually detected until it has reached advanced stages. How long an individual survives also is determined by the cancer treatment they receive. Although there are best treatment practices to improve survival, some women have other conditions that limit treatment options. One such condition seen in as many as 50% of women with advanced ovarian cancer is frailty (an age-related decline in function and health). This is a major concern as doctors will often have to change how the cancer is treated based on the patient being frail. For example, patients living with frailty are less likely to have their full tumor removed during surgery. They are also more likely to have complications with surgery, stay in the hospital longer, and recover less well from surgery overall. Patients living with frailty also are more likely to experience delays in their chemotherapy starting, receive lower doses of chemotherapy and/or receive fewer cycles of chemotherapy. These changes in treatment may decrease how long a patient survives after diagnosis. Thus, research is needed to explore strategies to decrease frailty in patients who require treatment for advanced ovarian cancer. An option gaining more attention is physical exercise (e.g. walking, repeatedly rising from a chair). Exercise performed before surgery, which is called prehabilitation, can improve how well a patient recovers after surgery and increase how long they survive. Research has shown that prehabilitation is very beneficial for patients undergoing surgery for heart disease. However, it is not clear whether prehabilitation works for those with advanced ovarian cancer that are going to have surgery. Therefore, the investigators want to explore how a 4+ week exercise program performed while waiting for surgery for advanced ovarian cancer changes frailty and how a patient recovers after surgery. The investigators will specifically look whether the exercise program: 1) reduces how frail a patient is before surgery; 2) improves how well the patient recovers after surgery; and 3) affects the patient's chemotherapy treatment plan. This study will provide important information about the ability of prehabilitation exercise to improve surgical and treatment outcomes in women with advanced ovarian cancer. Overall, it is believed that exercise has the potential to improve the survival of advanced ovarian cancer patients.

Research Team

Scott Grandy, MD

Principal Investigator

Nova Scotia Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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 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 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]

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]

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]

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]

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]

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

Adherence to Pre-operative Exercise and the Response to Prehabilitation in Oesophageal Cancer Patients. [2023]

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

Impact of prehabilitation during neoadjuvant chemotherapy and interval cytoreductive surgery on ovarian cancer patients: a pilot study. [2022]

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

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

5. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

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

7. Switzerland pubmed.ncbi.nlm.nih.gov

Prehabilitation to Improve Outcomes of Patients with Gynaecological Cancer: A New Window of Opportunity? [2022]

8. England 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). [2022]

9. France pubmed.ncbi.nlm.nih.gov

Combining prehabilitation with enhanced recovery programs in gynecological surgery. [2022]