FRAGINOC Study: Screening and Geriatric Assessment and Intervention in Older Patients With Epithelial Ovarian Cancer

NCT05810701 | Recruiting DMC

• 1 other identifier: OUHAgeCareOvarian
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 5

Brief Summary

Ovarian cancer (OC) is the fifth most common cause of cancer death. More than 40% are older than 70 years. The standard treatment is radical surgery combined with chemotherapy. More than 40% of the Danish patients will never undergo surgery. Frail and immunodeficient older patients are at higher risk of complications, and immunomodulating treatment as chemotherapy results in different outcomes in comparable patients. No accurate validated screening tool to identify frail and immunodeficient OC women exists. Optimization through comprehensive geriatric assessment (CGA) and physical training before and during treatment may improve outcomes and decrease associated risks. Aim: Primary endpoints will be to determine whether a CGA and physical training vs standard of care can increase the proportion of patients later on referred to interval debulking surgery, and examine the performance of validated screening tests in predicting impairments in CGA. Other endpoints will be to evaluate if intervention can improve completion of chemotherapy, to examine the association between frailty screening scores and selected biomarkers with treatment outcomes, including complications and quality of life, and ultimately to develop an improved frailty screening tool based on known screening tools, functional tests and biomarkers identifying patients who will benefit from CGA. Method: This is a nationwide, randomized intervention study. Patients ≥70 years diagnosed with primary OC at the Gynecological departments of Rigshospitalet, Odense and Roskilde University Hospitals will be included. In an interdisciplinary collaboration between medical specialists in oncology, gynecology and geriatrics, included patients will be screened for frailty using validated screening tools and functional tests. Specific biomarkers and immunologic profile will be assessed in all patients. Patients selected for neoadjuvant chemotherapy will be randomized to receive CGA or standard of care. Patients selected for primary debulking surgery or palliation will be followed in an observational cohort. Perspective: The development of a validated screening tool for frailty assessment and immunological status will help us identify frail patients who may need optimization before treatment, resulting in more patients getting optimal treatment (either surgery or chemotherapy), prevent post-treatment complications and avoid palliative patients from undergoing a redundant complex treatment.

Conditions

Ovarian Cancer; Frailty

Outcome Measures

Primary Outcomes (2)

• Interval Debulking Surgery

  Proportion of patients referred to interval debulking surgery

  Up to 8 months

• Frailty screening questionnaires

  Specificity and positive and negative predictive values of Geriatric-8, modified Geriatric-8 and Clinical Frailty Scale, in predicting impairments in Comprehensive Geriatric assessment

  Up to 8 months

Secondary Outcomes (11)

• Completion of chemotherapy treatment

  Up to 8 months

• Effect of training: Physical capacity and endurance

  Up to 8 months

• Effect of training: Physical function and strength

  Up to 8 months

• Effect of physical training: Physical function in relation to basic mobility

  Up to 8 months

• Effect of physical training: Physical function in relation to balance

  Up to 8 months

Other Outcomes (7)

• Comprehensive Geriatric Assessment

  Up to 8 months

• Hospital admissions related to chemotherapy

  Up to 8 months

• Physical activity in intervention group-walking

  Up to 8 months

Study Arms (2)

NACT and CGA+ physical training intervention

ACTIVE COMPARATOR

Elderly (≥70 years) ovarian cancer patients referred for Neo-adjuvant treatment randomized to comprehensive geriatric assessment and individualised physical training.

Other: Comprehensive geriatric assessment and individualised physical training

NACT no intervention

NO INTERVENTION

Elderly (≥70 years) ovarian cancer patients referred for Neo-adjuvant treatment randomized to standard of care

Interventions

Comprehensive geriatric assessment and individualised physical training OTHER

Comprehensive geriatric assessment and relevant intervention (including medical and pharmacological optimisation, nutritional, social and psychological intervention, among others), and individualised physical training

NACT and CGA+ physical training intervention

Eligibility Criteria

• Age: 70 Years - 120 Years
• Gender Eligibility Details: Women as only women are diagnosed with ovarian cancer
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Newly diagnosed ovarian cancer
• Capable of understanding written and oral danish

You may not qualify if:

• Other active cancers in the preceding 5 years
• Severe psychiatric disease
• Patients referred to primary debulking surgery will be followed in a observational design

Sponsors & Collaborators

• Odense University Hospital: lead
• Rigshospitalet, Denmark: collaborator
• Herlev Hospital: collaborator
• Zealand University Hospital: collaborator

Study Sites (5)

Odense University Hospital

Odense, Region of South Denmark, 5000, Denmark

RECRUITING

Vejle Hospital

Vejle, Region of South Denmark, 7100, Denmark

RECRUITING

Zealand University Hospital

Roskilde, Region Sjælland, 4000, Denmark

RECRUITING

Copenhagen University Hospital Rigshospitalet

Copenhagen, The Capital Region of Denmark, 2100, Denmark

RECRUITING

Herlev and Gentofte Hospital

Herlev, The Capital Region of Denmark, 2730, Denmark

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Frailty

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Central Study Contacts

Tine Henrichsen Schnack, PhD

CONTACT

+4527284828; tine.henrichsen.schnack@rsyd.dk

Trine Lembrecht Joergensen, PhD

CONTACT

Trine.Joergensen@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Associate Professor

Model Details: Rancomized clinical trial Combined observational study

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: April 12, 2023
• Study Start: February 1, 2023
• Primary Completion: February 1, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 12, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (5)