Ovarian Cancer Clinical Trial

Prehabilitation for Advanced Ovarian Cancer Patients

Summary

Physical activity plays an important role in reducing the adverse effects of cancer treatment. There are few studies using prehabilitation to improve peri-operative outcomes in patients undergoing cancer surgery. This study will pilot a program of structured activity for women undergoing neoadjuvant chemotherapy with the intent to improve their physical state prior to surgical intervention and thus improve outcomes.

It has been shown that patients with advanced ovarian cancer may suffer from high levels of cancer -specific distress, depression and anxiety. It has also been proposed that psychological resilience can favorably affect psychological and treatment-related outcomes in cancer patients. Most current studied mindfulness-based interventions are limited by the time commitment required by the patient, which is difficult for patients with advanced cancer undergoing treatment, therefore a virtual program has been created that is more easily accessible.

Frailty is thought to be mediated by senescent cells and their dynamic secretome, referred to as the senescence-associated secretory phenotype (SASP). Senescent cells contribute to age-related tissue deterioration, inflammation, and fibrosis. A group of novel frailty biomarkers obtained at the time of diagnosis has been examined in advanced OC patients. Preliminary data show that these biomarkers strongly correlate with the clinical frailty phenotype, and define a frail subgroup of patients with higher treatment related morbidity and worse survival. These markers may represent important surrogate clinical trial endpoints, as well as deepen the understanding of aging in women with ovarian cancer. In this pilot, these markers and other surrogate endpoints for future novel translational research in the science of aging will be explored.

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Full Description

With a rapidly growing older American population, the overall incidence of cancer, including ovarian cancer (OC) is rising. Addressing aging in older OC patients represents a clinically important unmet need. Interventions designed to improve resilience against loss of function, psychological distress, complications and premature mortality in older patients are lacking in OC treatment. Current OC treatment strategies are purely tumor-directed, and do not address host factors. Our overall goal is to test whether a holistic prehabilitation program can be implemented alongside standard tumor-directed therapy in the older OC patient and will improve function, quality of life, and reduce morbidity and mortality. The 12-week period of neoadjuvant chemotherapy prior to cytoreductive surgery is an ideal window of opportunity to utilize such a strategy. Prehabilitation must be: i) practicable at the institutional level, ii) feasible at the participant level, and iii) provide demonstrable benefits.

This pilot trial will examine baseline function of all patients diagnosed with advanced ovarian cancer who are intending on curative intent treatment. Patients will have a range of assessments including functional, psychologic, and biomarkers. Patients undergoing primary debulking surgery will be in an observational arm alone. Patients undergoing neoadjuvant chemotherapy will be assigned to a trimodal prehabilitation program that involves exercise, resilience training, and nutritional support. Patient will be evaluated on this arm at baseline, prior to surgery, post-operatively and at the completion of treatment.

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Eligibility Criteria

Inclusion Criteria:

Diagnosed with epithelial ovarian, fallopian tube, or primary peritoneal cancer based on imaging and physician diagnosis
Suspected Stage IIIC or IV disease based on clinician staging and imaging
Curative intent treatment with platinum-based chemotherapy
Planned surgical intervention at some point during treatment course.
Ability to read English
No diagnosed severe cognitive impairment
Ability to provide consent
Ability to utilize technology to watch online modules for the Resilient Living Program

Exclusion Criteria:

Hemiplegia or paraplegia
Current pregnancy

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

60

Study ID:

NCT05047926

Recruitment Status:

Recruiting

Sponsor:

Mayo Clinic

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There is 1 Location for this study

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Mayo Clinic
Rochester Minnesota, 55905, United States More Info
Karen P Ishitani, MSN, RN
Contact
507-538-5535
[email protected]
Clinical Trials Referral Office
Contact
855-776-0015
[email protected]
Amanika Kumar, M.D.
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

60

Study ID:

NCT05047926

Recruitment Status:

Recruiting

Sponsor:


Mayo Clinic

How clear is this clinincal trial information?

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