Exercise and Nutrition Intervention in Ovarian Cancer

NCT06250686 | Recruiting

• 1 other identifier: BENITA
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 7

Brief Summary

The objective of this multicenter randomized controlled trial is to compare a 6-month exercise and nutrition intervention (intervention group, IG) aimed at maintaining or improving physical functioning and quality of life with usual care (control group, CG) in ovarian cancer patients. The main question it aims to answer is:

• Can an exercise and nutrition program improve physical performance during and after active treatment for ovarian cancer? Participants of the IG will undergo:
• Weeks 1-18: approximately 15-30 minutes of daily exercise (cardio, resistance, and balance exercises); nutritional counseling focusing on malnutrition (protein-energy malnutrition).
• Weeks 19-25: More intense daily training; nutritional counseling focusing on the Mediterranean diet. The study design includes 3 survey time points:
• Baseline: After surgery and before starting chemotherapy
• T1: After chemotherapy (week 19)
• T2: After intervention (week 26) The primary outcome is:
• 6-minute walk test, 6 months after enrollment (T2)

Conditions

Ovarian Cancer; Malnutrition; Muscle Wasting; Fatigue

Outcome Measures

Primary Outcomes (1)

• 6 Minute Walk Test (distance in metre)

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

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

Secondary Outcomes (14)

• 6 Minute Walk Test (distance in metre)

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

• Global physical activity questionnaire (GPAQ)

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

• Assessment of body composition using bioelectrical impedance analysis (BIA)

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

• Grip force dynamometer

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

• Polyneuropathy; item derived from EORTC CIPN20 (Item 9)

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

Study Arms (2)

Control group

NO INTERVENTION

usual care

Intervention

EXPERIMENTAL

6 month exercise and nutrition intervention

Behavioral: combined exercise and nutrition intervention

Interventions

combined exercise and nutrition intervention BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with FIGO II-IV stage ovarian, fallopian tube, or peritoneal carcinoma
• Patients must be treated with surgery and chemotherapy
• Patients receiving adjuvant or neoadjuvant chemotherapy but not yet started

You may not qualify if:

• Patients with an Eastern Cooperative Oncology Group (ECOG) performance status greater than 2
• Patients with inadequate German language skills
• Patients with physical or mental impairments that make it impossible to perform the training programs or study procedures

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Charite University, Berlin, Germany: collaborator
• University Hospital Dresden: collaborator
• Kliniken Essen-Mitte: collaborator
• University Hospital Tuebingen: collaborator
• University Hospital Schleswig-Holstein: collaborator
• Technical University of Munich: collaborator

Study Sites (7)

Charité Universitätsmedizin Berlin

Berlin, 13353, Germany

RECRUITING

Universitätskrebszentrum Dresden

Dresden, 01307, Germany

NOT YET RECRUITING

Evang. Klinik Essen-Mitte

Essen, 45136, Germany

RECRUITING

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

Universitätsklinikum Schleswig-Holstein

Kiel, 24105, Germany

NOT YET RECRUITING

Klinikum rechts der Isar der Technischen Universität München Ismaniger Straße 22

München, 81675, Germany

NOT YET RECRUITING

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

NOT YET RECRUITING

Related Publications (1)

• Maurer T, Belau MH, Zyriax BC, Welsch G, Jagemann B, Chang-Claude J, Daubmann A, Buchholz A, Glismann K, Moeller A, Sehouli J, Woopen H, Wimberger P, Harter P, Kaiser S, Maass N, Kiechle M, Engler T, Schmalfeldt B, Schulz H. Study protocol of an exercise and nutrition intervention for ovarian cancer patients during and after first-line chemotherapy (BENITA) - a randomized controlled trial. BMC Cancer. 2024 Nov 11;24(1):1379. doi: 10.1186/s12885-024-13102-y.

  PMID: 39528997 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms; Malnutrition; Muscular Atrophy; Fatigue

Interventions

Diet Therapy

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; Nutrition Disorders; Nutritional and Metabolic Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Holger Schulz, Prof. Dr.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Holger Schulz, Prof. Dr.

CONTACT

+49 (0) 40 7410 56806; schulz@uke.de

Tabea Maurer, Dr.

CONTACT

+49 (0) 40 7410 50800; ta.maurer@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: February 9, 2024
• Study Start: January 10, 2024
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (7)