Background: Invasive epithelial ovarian cancer (EOC) is a highly fatal disease when diagnosed at advanced; few improvements in the treatment of EOC were obtained in the last years, till the introduction of bevacizumab therapy. Physical activity has been demonstrated to increase survival with cancer patients, and during chemotherapy is a promising strategy to reduce fatigue and improve health-related quality of life (HRQoL).The main purpose of this study will be to evaluate if a regular and structured exercise, during bevacizumab therapy will be able to improve the HRQoL in ovarian cancer. Methods/Design: The study is a prospective, randomized, open-label, multicenter phase 2 trial in EOC patients eligible for bevacizumab treatment. Participants will be randomized to an exercise intervention or a control group. The exercise intervention group will participate in a 12-weeks supervised exercise programme and the control group will receive only a general recommendation. The focus of the exercise is resistance training in combination with aerobic training. Participants are measured at baseline, after 12 weeks and after 24 weeks as part of the program. Primary endpoints change the quality of life evaluated by 6MWT test and EORT QLQC-30. Secondary endpoints include CPET, Bio-sample, muscle strength test and IPAQ-SF. Statistical analyses will include descriptive characteristics, t-tests, effect sizes and two-way repeated-measures analysis of variance to examine differences between groups over time. Discussion: The exercise program is safe, cheap and feasible and the studies have shown protective and treatments effect from cancer but it needs to be further investigated. The study design and the state-of-the-art assessments will help to increase knowledge about EOC in general and exercise as a potential treatment option in these patients under investigation.

DO COMBINED AEROBIC AND RESISTANCE EXERCISE INTERVENTION IMPROVE THE HRQOL IN EOC PATIENTS UNDERGOING BEVACIZUMAB TREATMENT? STUDY PROTOCOL FOR A MULTICENTER RANDOMIZED CONTROLLED TRIAL

Leydi Natalia Vittori
Methodology
;
Matteo Botteghi
Methodology
;
Pasqualino Maietta Latessa
Supervision
2020

Abstract

Background: Invasive epithelial ovarian cancer (EOC) is a highly fatal disease when diagnosed at advanced; few improvements in the treatment of EOC were obtained in the last years, till the introduction of bevacizumab therapy. Physical activity has been demonstrated to increase survival with cancer patients, and during chemotherapy is a promising strategy to reduce fatigue and improve health-related quality of life (HRQoL).The main purpose of this study will be to evaluate if a regular and structured exercise, during bevacizumab therapy will be able to improve the HRQoL in ovarian cancer. Methods/Design: The study is a prospective, randomized, open-label, multicenter phase 2 trial in EOC patients eligible for bevacizumab treatment. Participants will be randomized to an exercise intervention or a control group. The exercise intervention group will participate in a 12-weeks supervised exercise programme and the control group will receive only a general recommendation. The focus of the exercise is resistance training in combination with aerobic training. Participants are measured at baseline, after 12 weeks and after 24 weeks as part of the program. Primary endpoints change the quality of life evaluated by 6MWT test and EORT QLQC-30. Secondary endpoints include CPET, Bio-sample, muscle strength test and IPAQ-SF. Statistical analyses will include descriptive characteristics, t-tests, effect sizes and two-way repeated-measures analysis of variance to examine differences between groups over time. Discussion: The exercise program is safe, cheap and feasible and the studies have shown protective and treatments effect from cancer but it needs to be further investigated. The study design and the state-of-the-art assessments will help to increase knowledge about EOC in general and exercise as a potential treatment option in these patients under investigation.
2020
Leydi Natalia Vittori, Matteo Botteghi, Pasqualino Maietta Latessa
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11585/754735
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