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Prehabilitation for Advanced Ovarian Cancer Patients

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ClinicalTrials.gov Identifier: NCT05047926
Recruitment Status : Recruiting
First Posted : September 17, 2021
Last Update Posted : November 5, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Amanika Kumar, M.D., Mayo Clinic

Tracking Information
First Submitted Date  ICMJE September 8, 2021
First Posted Date  ICMJE September 17, 2021
Last Update Posted Date November 5, 2021
Actual Study Start Date  ICMJE October 1, 2021
Estimated Primary Completion Date December 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2021)
  • Exercise compliance [ Time Frame: 9 weeks ]
    This will evaluate patients ability to follow the prehabilitation program. Each day in which the participant completed >75% of the recommended exercise will be counted as compliant. The goal will be 60% compliance over the course of 9 weeks
  • Nutrition compliance [ Time Frame: 9 weeks ]
    This will evaluate patients ability to follow the prehabilitation program. Each day in which the participant drank 75% of the recommended protein supplement will be counted as compliant. The goal will be for 60% compliance over the course of 9 weeks
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2021)
  • Short Physical Performance Battery differences [ Time Frame: baseline ]
    Short Physical Performance Battery will be evaluated at baseline between the two cohorts.
  • Short Physical Performance Battery change [ Time Frame: 26 weeks +/- 12 weeks ]
    Short Physical Performance Battery will be evaluated from baseline to pre-operative and baseline to end of treatment.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2021)
  • SPPB differences [ Time Frame: baseline ]
    SPPB will be evaluated at baseline between the two cohorts.
  • SPPB change [ Time Frame: 26 weeks +/- 12 weeks ]
    SPPB will be evaluated from baseline to pre-operative and baseline to end of treatment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prehabilitation for Advanced Ovarian Cancer Patients
Official Title  ICMJE Prehabilitation for Advanced Ovarian Cancer Patients
Brief 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.

Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE
  • Behavioral: Exercise - Physical Activity
    The recommended exercise program will consist walking for 30 mins per day, 3 days per week, at any pace in any environment. In addition the subjects will be given resistance bands and instruction on following the REST program, a home-based upper and lower body strength program that uses resistance bands to improve strength and balance.
  • Behavioral: Resiliency Training
    The Resilient Living program is modified from the Stress Management and Resiliency Training (SMART) program; which has been shown to be effective in improving resiliency, perceived stress, anxiety, and overall quality of life in a variety of populations.
  • Dietary Supplement: Protein Supplementation
    Increased protein intake is recommended for persons with advance cancer due to malnutrition and low albumin levels. Protein intake recommendations are 1.2 -1.5 g/kg/day. A daily protein recommendation will be calculated at the time of enrollment and subjects will be allowed to select their preferred protein supplement.
Study Arms  ICMJE
  • No Intervention: Primary Cytoreductive Surgery
    Women diagnosed with or having a high suspicion for ovarian cancer and undergoing primary surgical intervention for debulking of tumor.
  • Experimental: Neoadjuvant Chemotherapy prior to Cytoreductive Surgery
    Women diagnosed with or having a high suspicion for ovarian cancer and recommended to have Neoadjuvant Chemotherapy (NACT) prior to undergoing an interval debulking surgical intervention.
    Interventions:
    • Behavioral: Exercise - Physical Activity
    • Behavioral: Resiliency Training
    • Dietary Supplement: Protein Supplementation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 8, 2021)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 15, 2023
Estimated Primary Completion Date December 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Karen P Ishitani, MSN 507-538-5355 ishitani.karen@mayo.edu
Contact: Maureen A Lemens, BSN 507-293-1487 lemens.maureen@mayo.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05047926
Other Study ID Numbers  ICMJE 21-005226
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amanika Kumar, M.D., Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Amanika Kumar, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP