Prehabilitation Program for Advanced Ovarian Cancer

Recruiting at 1 trial location

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: Platinum-based chemotherapy

Disqualifiers: Hemiplegia, Paraplegia, Pregnancy

Stay on Your Current Meds You can continue your current medications while participating

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 4 months

100 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.

What data supports the effectiveness of the treatment Prehabilitation Program for Advanced Ovarian Cancer?

Research shows that physical activity can improve quality of life and reduce distress in ovarian cancer survivors. Additionally, patients with advanced ovarian cancer are motivated to exercise during chemotherapy, believing it benefits their overall health and cancer outcomes. ^{1 2 3 4 5}

Is the Prehabilitation Program for Advanced Ovarian Cancer safe for humans?

Exercise interventions, including walking and strength training, have been shown to be safe for women with ovarian cancer, even during chemotherapy. Patients reported motivation to exercise when advised by their healthcare team, despite barriers like fatigue and nausea. ^{1 6 7 8 9}

How does the prehabilitation program for advanced ovarian cancer differ from other treatments?

The prehabilitation program for advanced ovarian cancer is unique because it prepares patients physically and mentally before surgery through exercise, nutrition, and psychological support, aiming to improve recovery and functional outcomes, unlike standard treatments that focus solely on surgery and chemotherapy. ^{10 11 12 13 14}

What is the purpose of this trial?

This clinical trial evaluates whether a prehabilitation program started at the time of neoadjuvant chemotherapy will affect surgical recovery in patients with stage IIIC-IV ovarian, fallopian tube, or primary peritoneal cancer. A prehabilitation program may improve the quality of life after surgery for patients with ovarian, fallopian tube, or primary peritoneal cancer.

Research Team

Amanika A. Kumar, MD

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

This trial is for English-reading adults over 18 with stage IIIC-IV ovarian, fallopian tube, or primary peritoneal cancer. They should be able to use technology and consent to participate. It's not for those who are pregnant or have hemiplegia/paraplegia.

Inclusion Criteria

I have been treated with platinum-based chemotherapy aiming for a cure.

Ability to provide consent

My cancer is suspected to be in an advanced stage.

Exclusion Criteria

I have paralysis on one side of my body or both legs.

Current pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants engage in a prehabilitation program including physical activity, nutritional supplements, and resilience training

Up to 4 months

Weekly remote or in-person sessions

Treatment

Participants receive neoadjuvant chemotherapy and undergo various assessments

Up to 4 months

Regular visits for chemotherapy and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks post-surgery

Treatment Details

Interventions

• Exercise - Physical Activity
• Protein Supplementation
• Resiliency Training

Trial Overview The study tests a prehabilitation program combining behavioral counseling, nutritional supplements, and physical activity started during chemotherapy to see if it helps recovery after surgery for certain cancers.

Participant Groups

Group I: Cohort 3 (exercise, supplement, coaching, Resilient Living) Experimental Treatment 6 Interventions

Patients undergoing neoadjuvant chemotherapy complete physical activity remotely for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily. Patients also undergo health coaching remotely for 60 minutes weekly, complete Resilient Living program remotely over 60 minutes, and may wear a FitBit throughout the study.

Group II: Cohort 2 (exercise, supplement, Resilient Living) Experimental Treatment 5 Interventions

Patients undergoing neoadjuvant chemotherapy complete physical activity for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily, and complete Resilient Living program in-person or remotely over 60 minutes. Patients also undergo CT scans throughout the trial.

Group III: Cohort 1 (surveys, CT, blood samples) Experimental Treatment 3 Interventions

Patients undergoing primary surgical intervention complete surveys, undergo CT, and undergo collection of blood samples at baseline.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Patients with advanced ovarian cancer showed a strong willingness to engage in exercise during neoadjuvant chemotherapy, with 93% interested in walking and 87% in strength training, indicating a potential for prehabilitation to enhance resilience.

Key motivators for exercise included perceived health benefits and encouragement from healthcare providers, while barriers such as treatment-related symptoms and access to care were significant challenges that need to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced ovarian cancer patients identify opportunities for prehabilitation: A qualitative study. Polen-De, C., Langstraat, C., Asiedu, GB., et al.[2021]

Only 31.1% of ovarian cancer survivors surveyed met the recommended physical activity guidelines, indicating a need for increased engagement in physical activity among this population.

Survivors who adhered to these guidelines reported a significantly better quality of life, suggesting a positive dose-response relationship between physical activity and well-being, which warrants further clinical investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations between physical activity and quality of life in ovarian cancer survivors. Stevinson, C., Faught, W., Steed, H., et al.[2015]

Nearly 40% of women with ovarian cancer reduced their physical activity in the first year after diagnosis, and about 25% continued to have lower activity levels even 2-4 years later.

Higher levels of physical activity after diagnosis were linked to lower depression scores and better quality of life, suggesting that maintaining or increasing activity may positively impact psychosocial health in ovarian cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity in women with ovarian cancer and its association with decreased distress and improved quality of life. Beesley, VL., Price, MA., Butow, PN., et al.[2015]

A tailored, exercise-based physical therapy program for patients with metastatic breast cancer showed a high participation rate of 34% and a median adherence of 90%, indicating good feasibility and safety with no major adverse events reported.

Out of the patients who completed the program, 52% achieved their main goals, and 85% expressed a willingness to recommend the program, highlighting its positive impact on patient satisfaction and perceived physical functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and outcomes of a goal-directed physical therapy program for patients with metastatic breast cancer. Groen, WG., Ten Tusscher, MR., Verbeek, R., et al.[2021]

Exercise interventions for women during or after treatment for gynaecological cancer show significant improvements in physical outcomes such as aerobic capacity, muscular strength, and agility, based on a review of 11 studies including randomized controlled trials and cohort studies.

There was no evidence that exercise worsened any outcomes, suggesting that exercise is a safe and beneficial intervention for this population, although the effects on quality of life and other measures were inconsistent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of exercise interventions for women during and after gynaecological cancer treatment - a systematic scoping review. Rose, GL., Stewart, EM., Clifford, BK., et al.[2023]

A 26-week home-based exercise program requiring 225 minutes of physical activity per week was found to be feasible and acceptable for women with ovarian cancer, with 80% of participants successfully completing the program.

Participants, including those undergoing chemotherapy, showed significant improvements in physical activity levels, with an increase of 1,593 average steps per day and 15 additional minutes of moderate-intensity activity, all without any adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Among Women With Ovarian Cancer: A Feasibility and Pre-/Post-Test Exploratory Pilot Study. Zhang, X., McClean, D., Ko, E., et al.[2018]

Ovarian cancer survivors often experience treatment-related symptoms and comorbidities that negatively impact their physical health, including high rates of overweight and obesity, malnutrition, and low muscle density, which can lead to worse survival outcomes.

There is a significant need for tailored physical activity and exercise interventions for ovarian cancer survivors, as many are insufficiently active or sedentary, but current knowledge gaps hinder the development of specific exercise guidelines for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Physiological Profile of Ovarian Cancer Survivors to Inform Tailored Exercise Interventions and the Development of Exercise Oncology Guidelines. Schofield, C., Newton, RU., Galvão, DA., et al.[2018]

Most women with ovarian cancer experience a decrease in physical activity (PA) after diagnosis, which is linked to lower health-related quality of life and higher levels of anxiety and depression.

Exercise interventions are safe and feasible for women with ovarian cancer, leading to improvements in health-related quality of life, fatigue, and psychological outcomes, highlighting the importance of maintaining physical activity during and after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and exercise in women with ovarian cancer: A systematic review. Jones, TL., Sandler, CX., Spence, RR., et al.[2021]

A walking intervention during chemotherapy for ovarian cancer was found to be safe and feasible, with 17 women participating and adhering to over 80% of their sessions, indicating high acceptability of the program.

Participants showed meaningful improvements in physical functioning, symptoms, and quality of life, with 76% completing at least 85% of their chemotherapy dose, suggesting that exercise may support treatment adherence and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, feasibility and effects of an individualised walking intervention for women undergoing chemotherapy for ovarian cancer: a pilot study. Newton, MJ., Hayes, SC., Janda, M., et al.[2021]

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]

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 involves rehabilitation strategies before intensive cancer treatments, has been shown to improve functional outcomes and tolerability for patients undergoing surgery and other anti-cancer therapies.

Current evidence supports the integration of prehabilitation as a standard practice in oncology care, with future research needed to explore its effects on treatment responses and disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation is the Gateway to Better Functional Outcomes for Individuals with Cancer. Stout, NL., Fu, JB., Silver, JK.[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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Advanced ovarian cancer patients identify opportunities for prehabilitation: A qualitative study. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Associations between physical activity and quality of life in ovarian cancer survivors. [2015]

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

Physical activity in women with ovarian cancer and its association with decreased distress and improved quality of life. [2015]

4. Germany pubmed.ncbi.nlm.nih.gov

Feasibility and outcomes of a goal-directed physical therapy program for patients with metastatic breast cancer. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of exercise interventions for women during and after gynaecological cancer treatment - a systematic scoping review. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Exercise Among Women With Ovarian Cancer: A Feasibility and Pre-/Post-Test Exploratory Pilot Study. [2018]

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

A Physiological Profile of Ovarian Cancer Survivors to Inform Tailored Exercise Interventions and the Development of Exercise Oncology Guidelines. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Physical activity and exercise in women with ovarian cancer: A systematic review. [2021]

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

Safety, feasibility and effects of an individualised walking intervention for women undergoing chemotherapy for ovarian cancer: a pilot study. [2021]

10. England pubmed.ncbi.nlm.nih.gov

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

11. England pubmed.ncbi.nlm.nih.gov

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

12. 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]

13. Italy pubmed.ncbi.nlm.nih.gov

Prehabilitation is the Gateway to Better Functional Outcomes for Individuals with Cancer. [2022]

14. England pubmed.ncbi.nlm.nih.gov

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