ABSTRACT
Objective: This study describes the development and examines the feasibility of an exercise therapy program for women aged 70 years or older with advanced EOC, receiving neoadjuvant chemotherapy (NACT) before possible major surgery. Methods: In this feasibility study, patients participated in a mainly home-based exercise therapy program, including progressive resistance training, physical activity, and support from the supervising physiotherapist. The program included both supervised virtual and face-to-face sessions and self-administered daily exercise. Clinician-reported, patient-reported and physical performance measures were collected before and after NACT. Retention, adherence, and compliance to the program was monitored, and patient acceptability was explored in semi-structured interviews. Results: Fifteen patients, median age of 77 years (range 70-85) completed the exercise therapy program concurrently to receiving NACT lasting a median of 12 weeks. Patients were physically frail at baseline but improved at follow-up on measures of performance status, level of frailty, patient-reported physical fitness, lower body strength, aerobic functional capacity, basic mobility, balance, and number of steps per day. High levels of participation were found to both supervised and self-administered exercise. Patient interviews highlighted the homebased setting, the individualised tailoring of exercises and the support from the physiotherapist as reasons to complete the exercise therapy program as prescribed. Conclusions: The exercise therapy program was found to be feasible and acceptable in women aged 70 years or older with advanced EOC, receiving NACT before possible major surgery. The observed improvements and the positive experiences perceived by the patients support future application in research and clinical practice.
ABSTRACT
INTRODUCTION: Radical surgery combined with chemotherapy is the only potential curative treatment of patients with advanced epithelial ovarian cancer (EOC). However, 43% of older Danish patients with EOC are not referred to surgery due to frailty, age, or fear of complications. Comprehensive geriatric assessment (CGA) has demonstrated ability to reduce frailty in older patients, but there is a knowledge gap regarding its effect before or during treatment in older adults with EOC. This protocol presents a randomized controlled trial (RCT), which evaluates the effect of CGA-based interventions including individualized physical exercise therapy in older adults with EOC during neoadjuvant chemotherapy (NACT). MATERIALS AND METHODS: This RCT will include patients aged ≥70 years with primary EOC referred to NACT. Patients will be randomized 1:1 to intervention or standard of care, along with neoadjuvant antineoplastic treatment. Stratification for performance status and center of inclusion will be performed. In the intervention arm, a geriatrician will perform CGA and corresponding geriatric interventions and patients will undergo an individualized home-based exercise program managed by a physiotherapist. All patients will be evaluated with Geriatric-8, modified Geriatric-8, clinical frailty scale, and physical tests at randomization. Predictive values (positive/negative) will be evaluated for CGA detected impairments. The primary endpoint is the proportion of patients referred to interval debulking surgery (IDS). Secondary endpoints include the proportion who complete oncological treatment, improvements in physical tests, quality of life measured by European Organization for Research and Treatment of Cancer-Quality of Life questionnaires at inclusion, after three cycles of chemotherapy, and at end of chemotherapy treatment. Furthermore, the association between results of geriatric screening tests, CGA, and physical tests with complication rate and progression free survival will be examined. The primary outcome will be analyzed with logistic regression in the intention-to-treat population. Power calculations reveal the need to enroll 216 patients. DISCUSSION: The present study examines whether CGA-based interventions including individualized physical exercise can increase the referral rate for potential curative IDS in older patients with EOC. If successful, this will result in more patients undergoing surgery and completing chemotherapy, preventing complications, and ultimately improving quality of life and survival. The study setup may establish the basis for direct clinical implementation if proven effective.