Evidence map›Paper›PMID 39528997›Full record

ArticleBMC cancer2024

Study protocol of an exercise and nutrition intervention for ovarian cancer patients during and after first-line chemotherapy (BENITA) - a randomized controlled trial.

Tabea Maurer, M H Belau, B-C Zyriax, G Welsch, B Jagemann, J Chang-Claude, A Daubmann, A Buchholz, K Glismann, A Moeller and 10 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06250686 (Exercise and Nutrition Intervention in Ovarian Cancer - Development of a Care Concept and Evaluation in Routine Clinical Practice), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06250686 naunknown statusnot on this map

Exercise and Nutrition Intervention in Ovarian Cancer - Development of a Care Concept and Evaluation in Routine Clinical Practice

TypeinterventionalSponsorUniversitätsklinikum Hamburg-EppendorfRan2024 to 2025Enrolled185ConditionsOvarian Cancer, Malnutrition, Muscle Wasting, FatigueArmscombined exercise and nutrition intervention
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Beyond breast cancer: mapping unmet needs and advancing an evidence-based framework of survivorship care.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Review
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Tabea MaurerCenter for Psychosocial Medicine, Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. ta.maurer@uke.de.
M H BelauInstitute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
B-C ZyriaxMidwifery Science-Health Care Research and Prevention, Research Group Preventive Medicine and Nutrition, Institute for Health Service Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
G WelschOrthopedic Sports Medicine, Department of Trauma and Orthopedic Surgery, UKE Athleticum, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
B JagemannMidwifery Science-Health Care Research and Prevention, Research Group Preventive Medicine and Nutrition, Institute for Health Service Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
J Chang-ClaudeDivision of Cancer Epidemiology, German Cancer Research Center (DKFZ)University Medical Centre Hamburg-Eppendorf, University Cancer Centre Hamburg (UCCH), Heidelberg, Germany.
A DaubmannInstitute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
A BuchholzInstitute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
K GlismannOrthopedic Sports Medicine, Department of Trauma and Orthopedic Surgery, UKE Athleticum, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
A MoellerOrthopedic Sports Medicine, Department of Trauma and Orthopedic Surgery, UKE Athleticum, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
J SehouliDepartment of Gynecology with Center for Oncological Surgery, Charite Comprehensive Cancer Center, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt- Universität zu Berlin, Berlin, Germany.
H WoopenDepartment of Gynecology with Center for Oncological Surgery, Charite Comprehensive Cancer Center, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt- Universität zu Berlin, Berlin, Germany.
P WimbergerNational Center for Tumor Diseases Dresden, Department of Gynecology and Obstetrics, University Hospital Dresden, TU Dresden, Dresden, Germany.
P HarterDepartment of Gynecology & Gynecologic Oncology, Ev. Kliniken Essen-Mitte, Essen, Germany.
S KaiserDepartment of Gynecology & Gynecologic Oncology, Ev. Kliniken Essen-Mitte, Essen, Germany.
N MaassDepartment of Gynecology and Obstetrics, University Hospital of Schleswig-Holstein, Campus Kiel, Kiel, Germany.
M KiechleDepartment of Gynecology and Obstetrics, University Hospital Rechts der Isar, Technical University Munich (TU), Munich, Germany.
T EnglerDepartment of Women's Health, Tübingen University Hospital, Tübingen, Germany.
B Schmalfeldt *Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
H Schulz *Center for Psychosocial Medicine, Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn ovarian cancer frequently reported side effects are muscle wasting and malnutrition, leading to frailty, decreased health-related quality of life (HRQoL), and cancer-related fatigue (CRF). Both often begin during first-line chemotherapy and develop progressively into a refractory state, if left untreated.

methodPrimary objective is to evaluate effectiveness of a newly developed app-based exercise and nutrition program under non-standardized conditions of clinical routine. We hypothize that patients who receive an individually tailored exercise and nutrition program for six months will have improved physical performance compared to patients who receive usual care. This is a multicenter randomized controlled open-label trial comparing an intervention group receiving a six-month exercise and nutrition intervention and a control group receiving usual care. Primary endpoint is the change in 6-Minute Walk Test (6MWT) from baseline to T2 (26 weeks after baseline) as a measure of physical functioning. Secondary endpoints include patients' utilization and adherence to the nutrition program (MEDAS), their malnutrition risk (NRS2002), as well as patients' HRQoL (see Table 1). Using the two-sample t-test with a two-sided type I error of 5% and 80% power, a medium effect size of Cohen's d = 0.50 can be demonstrated with a minimum of 128 participants (64 per group). With a conservatively estimated dropout rate of 30%, 182 patients will be recruited. Patients who are included must be over 18 years of age, be diagnosed with ovarian cancer, cancer of fallopian tubes, or peritoneal cancer, FIGO stages II-IV, receive surgery and chemotherapy (adjuvant or neoadjuvant). Exclusion criteria are an ECOG status greater than 2, inadequate proficiency in German, or physical or mental impairments hindering the implementation of the program or execution of study procedures. DISCUSSION: In case of success, the project contributes in the long term to (i) improving medical care (diagnosis, psychoeducation, patient orientation, and empowerment), (ii) reducing the burden of disease and promoting physical autonomy for patients, and (iii) being incorporated into relevant guidelines.

trial registrationThe study was registered at ClinicalTrials.gov (NCT06250686).

Indexed as

Exercise TherapyOvarian NeoplasmsQuality of LifeAdultAgedExerciseFemaleHumansMalnutritionMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as TopicExerciseMalnutritionMuscle wastingNutritionOvarian cancerRandomized controlled trial

Identifiers

PMID39528997
PMCPMC11552146

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.