Exercise and Nutrition Intervention in Ovarian Cancer

Browse trials for

• Ovarian Neoplasms 2,695
• Carcinoma, Ovarian Epithelial 1,617
• Muscular Atrophy 494
• Malnutrition 1,587

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's planned enrollment of 185 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 403 studies on the registry; 83 are open to participants now.

Study arms

• No intervention
  Control group

  usual care

• Experimental
  Intervention

  6 month exercise and nutrition intervention

  Behavioral: combined exercise and nutrition intervention

Interventions

• Behavioralcombined exercise and nutrition intervention

  Patients will be instructed on how to use the Physitrack app. At the start of chemotherapy, patients will be contacted by physiotherapists and dietitians from the University Medical Center Hamburg-Eppendorf either via video call using the app or by phone to discuss the first week's program. Patients can either complete the exercise program at home using the app or receive printed exercise plans in the mail to be completed with the physical therapist of their choice. The exercise program is adjusted weekly until week 9. After week 10, adjustments are made every two weeks. For each program, patients receive a 30-minute counseling session to discuss the exercises. The 30-minute nutritional counseling session occurs every two weeks. For patients receiving neoadjuvant chemotherapy, the exercise program is interrupted for the time of surgery and the two-week recovery period and resumed when chemotherapy is resumed.

Primary outcomes

1. 6 Minute Walk Test (distance in metre)

   Sub-maximal exercise test used to assess aerobic capacity and endurance

   Time frame: Change in the total distance from T2 (6 months after enrollment) to baseline as target

Secondary outcomes

1. 6 Minute Walk Test (distance in metre)

   Sub-maximal exercise test used to assess aerobic capacity and endurance

   Time frame: Change in the total distance from T1 (end of chemotherapy, approx. week 18-19) to baseline as target

2. Global physical activity questionnaire (GPAQ)

   Physical activity in minutes per day, MET minutes per week

   Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))

3. Assessment of body composition using bioelectrical impedance analysis (BIA)

   Bioelectrical impedance analyzers use an alternating electric current to measure the two components of bioelectrical impedance in the human body, resistance r and reactance Xc. In electrophysiological terms, resistance (per unit volume) correlates negatively with the amount of body fluid (body water and fat-free mass (FFM)) through which the current flows, while reactance correlates positively with the mass of body cells. The magnitude of Xc in relation to R is expressed as the phase angle (PA). From the measured R and Xc values and other subject data, additional indicators of body composition (e.g., total body water, fat-free mass, and fat mass) can be estimated using specific prediction equations based on modeling assumptions that are generally population-, age-, sex-, fat-, and disease-specific.

   Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))

4. Grip force dynamometer

   Hand gripping force (kg)

   Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))

5. Polyneuropathy; item derived from EORTC CIPN20 (Item 9)

   Problems standing or walking, because can't longer feel the ground under feet

   Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))

6. Patient Health Questionnaire-9 (PHQ-9)

   Depression screening

   Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))

7. Generalized Anxiety Disorder using GAD-2

   Anxiety

   Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))

8. Adherence to a Mediterranean diet (MEDAS)

   Adherence to a Mediterranean diet is assessed using the 14-item Mediterranean Diet Adherence Screener (MEDAS).

   Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))

9. EORTC QLQ-C30

   Quality of life (multidimensional) across 10 subscales

   Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))

10. EORTC OV-28

    Quality of life (multidimensional) focusing on ovarian cancer across 7 subscales

    Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))

11. EORT FA-12

    Quality of life (multidimensional) focusing on fatigue

    Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))

12. Nutritional Risk Screening (NRS 2002)

    Malnutrition risk

    Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))

13. Brief Social Support Scale (BS6)

    Social support (tangible support, emotional-informational support)

    Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))

14. Patient Activation Measure (PAM-13)

    Patient Activation Measure

    Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))

Individual participant data

Plan to share: No — The study protocol will be published in a peer-reviewed journal at the outset. The Statistical Analysis Plan (SAP), Informed Consent Form (ICF), and analysis code will be provided upon request, if available at the time of request.