Physical Activity and Dietary intervention in OVArian cancer (PADOVA): a RCT evaluating effects on body composition, physical function, and fatigue

Physical Activity and Dietary intervention in OVArian cancer (PADOVA): a RCT evaluating effects on body composition, physical function, and fatigue - PADOVA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55552

Enrollment

122

Registered

2017-08-11

Start date

2018-02-15

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian cancer

Interventions

The intervention group will receive a supervised exercise and dietary intervention during chemotherapy treatment (18 weeks). Supervised one-hour exercise sessions include aerobic and resistance exer

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Women (aged >= 18 years) who are scheduled for (neo)adjuvant first-line chemotherapy treatment for histologically confirmed primary epithelial ovarian-, fallopian tube or extra-ovarian cancer.

Exclusion criteria

Exclusion criteria: - not being able to perform basic activities of daily living - cognitive disorder or severe emotional instability (e.g. schizophrenia, Alzheimer) - contraindications of exercise (e.g. heart failure) - inability to read and write Dutch - life expectancy

Design outcomes

Primary

Measure	Time frame
Primary outcomes are body composition, physical function and fatigue.	—

Secondary

Measure	Time frame
Secondary outcomes include physical activity and fitness, body mass index, dietary intake, health-related quality of life and symptoms related to ovarian cancer and its treatment (pain, fatigue, nausea/vomiting, neuropathy), anxiety and depression, blood samples, sleep disturbances and chemotherapy completion rates. Additionally, an extensive process evaluation will be conducted to examine how and why the intervention was (un)successful. Clinical parameters (e.g. FIGO stage, comorbidities and survival) will be collected from medical records. Blood will be drawn for future analyses to examine biological mechanisms linking exercise to clinical outcomes, such as reduced inflammation, improved immune function, vascularization and perfusion, and insulin-like growth factor-axis.	—

Measure

Time frame

Secondary outcomes include physical activity and fitness, body mass index, dietary intake, health-related quality of life and symptoms related to ovarian cancer and its treatment (pain, fatigue, nausea/vomiting, neuropathy), anxiety and depression, blood samples, sleep disturbances and chemotherapy completion rates. Additionally, an extensive process evaluation will be conducted to examine how and why the intervention was (un)successful. Clinical parameters (e.g. FIGO stage, comorbidities and survival) will be collected from medical records. Blood will be drawn for future analyses to examine biological mechanisms linking exercise to clinical outcomes, such as reduced inflammation, improved immune function, vascularization and perfusion, and insulin-like growth factor-axis.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)