Ovarian Cancer Clinical Trial
Prehabilitation for Stage IIIC-IV Ovarian, Fallopian Tube, or Primary Peritoneal 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.
Full Description
PRIMARY OBJECTIVES:
I. To evaluate the baseline difference in objective frailty measurements in patients with advanced ovarian cancer clinically deemed acceptable for primary surgery versus neoadjuvant chemotherapy.
II. To evaluate level of adherence and retention of patients with advanced ovarian cancer undergoing neoadjuvant chemotherapy with a prehabilitation program.
EXPLORATORY OBJECTIVE:
I. Will examine longitudinal trends and variability in function by the Short Physical Performance Battery (SPPB) over time and in response to the intervention.
OUTLINE: Patients are assigned to 1 of 3 cohorts.
COHORT 1: Patients undergoing primary surgical intervention complete surveys, undergo computed tomography (CT), and undergo collection of blood samples at baseline.
COHORT 2: 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.
COHORT 3: 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.
Eligibility Criteria
Inclusion Criteria:
Age >= 18 years old
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
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There is 1 Location for this study
Rochester Minnesota, 55905, United States More Info
Principal Investigator
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