An exercise and nutrition intervention for ovarian cancer patients during and after first-line chemotherapy (BENITA study): a randomized controlled pilot trial

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An exercise and nutrition intervention for ovarian cancer patients during and after first-line chemotherapy (BENITA study): a randomized controlled pilot trial. / Maurer, Tabea; von Grundherr, Julia; Patra, Stefan; Jäger, Anna; Becher, Heiko; Schmalfeld, Barbara; Zyriax, Birgit-Christiane; Chang-Claude, Jenny.

in: INT J GYNECOL CANCER, Jahrgang 30, Nr. 4, 04.2020, S. 541-545.

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@article{c8d34603eac44430a83a9340a775e08f,
title = "An exercise and nutrition intervention for ovarian cancer patients during and after first-line chemotherapy (BENITA study): a randomized controlled pilot trial",
abstract = "BACKGROUND: Data on the treatment-supporting effect of modifiable lifestyle factors such as nutrition and physical activity on survival or quality of life (QoL) are scarce in patients with ovarian cancer. Despite a strong rationale for evaluating the effect of a multimodal intervention and multiple studies targeting other cancer sites, randomized controlled trials (RCTs) on the effects of a combined nutrition and exercise intervention on survival and QoL in ovarian cancer patients are rare. No study has investigated the impact of an early intervention during first-line chemotherapy.PRIMARY OBJECTIVES: To evaluate the study design, feasibility, safety, and acceptance of combined nutrition and exercise in patients diagnosed with ovarian cancer during and after first-line chemotherapy.STUDY HYPOTHESIS: Physical exercise and a cancer-specific nutrition intervention after ovarian cancer diagnosis is feasible, accepted, and safe for patients receiving first-line chemotherapy.TRIAL DESIGN: A 1:1 RCT with an intervention group and a control group. The intervention group receives an exercise and nutrition program whereas the control group continues to follow the usual care.MAJOR INCLUSION/EXCLUSION CRITERIA: Inclusion: women ≥18 years of age; women diagnosed with ovarian cancer, tubal cancer, or peritoneal cancer and primary or interval debulking surgery. Exclusion: Eastern Cooperative Oncology Group (ECOG) status of 2 or worse.PRIMARY ENDPOINTS: Recruitment rate, completion rate, side effects, and adherence.SAMPLE SIZE: n=30 patients (15 per arm) will be recruited.ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Accrual completion is planned for the end of 2019. Results will be presented in the months following study completion 1 year after recruitment has been finalised.TRIAL REGISTRATION NUMBER: The pilot phase was approved by the ethics committee of the Medical Faculty of Hamburg on December 13, 2017 (PV5456). The study was registered on September 9, 2018 at the German Study Registry for Clinical Studies (DRKS00013231).",
keywords = "Chemotherapy, Adjuvant, Counseling, Diet, Healthy/methods, Exercise Therapy/methods, Feasibility Studies, Female, Humans, Multicenter Studies as Topic, Nutrition Therapy/methods, Nutritional Status, Ovarian Neoplasms/drug therapy, Pilot Projects, Randomized Controlled Trials as Topic",
author = "Tabea Maurer and {von Grundherr}, Julia and Stefan Patra and Anna J{\"a}ger and Heiko Becher and Barbara Schmalfeld and Birgit-Christiane Zyriax and Jenny Chang-Claude",
note = "{\textcopyright} IGCS and ESGO 2020. No commercial re-use. See rights and permissions. Published by BMJ.",
year = "2020",
month = apr,
doi = "10.1136/ijgc-2019-000585",
language = "English",
volume = "30",
pages = "541--545",
journal = "INT J GYNECOL CANCER",
issn = "1048-891X",
publisher = "Lippincott Williams and Wilkins",
number = "4",

}

RIS

TY - JOUR

T1 - An exercise and nutrition intervention for ovarian cancer patients during and after first-line chemotherapy (BENITA study): a randomized controlled pilot trial

AU - Maurer, Tabea

AU - von Grundherr, Julia

AU - Patra, Stefan

AU - Jäger, Anna

AU - Becher, Heiko

AU - Schmalfeld, Barbara

AU - Zyriax, Birgit-Christiane

AU - Chang-Claude, Jenny

N1 - © IGCS and ESGO 2020. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2020/4

Y1 - 2020/4

N2 - BACKGROUND: Data on the treatment-supporting effect of modifiable lifestyle factors such as nutrition and physical activity on survival or quality of life (QoL) are scarce in patients with ovarian cancer. Despite a strong rationale for evaluating the effect of a multimodal intervention and multiple studies targeting other cancer sites, randomized controlled trials (RCTs) on the effects of a combined nutrition and exercise intervention on survival and QoL in ovarian cancer patients are rare. No study has investigated the impact of an early intervention during first-line chemotherapy.PRIMARY OBJECTIVES: To evaluate the study design, feasibility, safety, and acceptance of combined nutrition and exercise in patients diagnosed with ovarian cancer during and after first-line chemotherapy.STUDY HYPOTHESIS: Physical exercise and a cancer-specific nutrition intervention after ovarian cancer diagnosis is feasible, accepted, and safe for patients receiving first-line chemotherapy.TRIAL DESIGN: A 1:1 RCT with an intervention group and a control group. The intervention group receives an exercise and nutrition program whereas the control group continues to follow the usual care.MAJOR INCLUSION/EXCLUSION CRITERIA: Inclusion: women ≥18 years of age; women diagnosed with ovarian cancer, tubal cancer, or peritoneal cancer and primary or interval debulking surgery. Exclusion: Eastern Cooperative Oncology Group (ECOG) status of 2 or worse.PRIMARY ENDPOINTS: Recruitment rate, completion rate, side effects, and adherence.SAMPLE SIZE: n=30 patients (15 per arm) will be recruited.ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Accrual completion is planned for the end of 2019. Results will be presented in the months following study completion 1 year after recruitment has been finalised.TRIAL REGISTRATION NUMBER: The pilot phase was approved by the ethics committee of the Medical Faculty of Hamburg on December 13, 2017 (PV5456). The study was registered on September 9, 2018 at the German Study Registry for Clinical Studies (DRKS00013231).

AB - BACKGROUND: Data on the treatment-supporting effect of modifiable lifestyle factors such as nutrition and physical activity on survival or quality of life (QoL) are scarce in patients with ovarian cancer. Despite a strong rationale for evaluating the effect of a multimodal intervention and multiple studies targeting other cancer sites, randomized controlled trials (RCTs) on the effects of a combined nutrition and exercise intervention on survival and QoL in ovarian cancer patients are rare. No study has investigated the impact of an early intervention during first-line chemotherapy.PRIMARY OBJECTIVES: To evaluate the study design, feasibility, safety, and acceptance of combined nutrition and exercise in patients diagnosed with ovarian cancer during and after first-line chemotherapy.STUDY HYPOTHESIS: Physical exercise and a cancer-specific nutrition intervention after ovarian cancer diagnosis is feasible, accepted, and safe for patients receiving first-line chemotherapy.TRIAL DESIGN: A 1:1 RCT with an intervention group and a control group. The intervention group receives an exercise and nutrition program whereas the control group continues to follow the usual care.MAJOR INCLUSION/EXCLUSION CRITERIA: Inclusion: women ≥18 years of age; women diagnosed with ovarian cancer, tubal cancer, or peritoneal cancer and primary or interval debulking surgery. Exclusion: Eastern Cooperative Oncology Group (ECOG) status of 2 or worse.PRIMARY ENDPOINTS: Recruitment rate, completion rate, side effects, and adherence.SAMPLE SIZE: n=30 patients (15 per arm) will be recruited.ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Accrual completion is planned for the end of 2019. Results will be presented in the months following study completion 1 year after recruitment has been finalised.TRIAL REGISTRATION NUMBER: The pilot phase was approved by the ethics committee of the Medical Faculty of Hamburg on December 13, 2017 (PV5456). The study was registered on September 9, 2018 at the German Study Registry for Clinical Studies (DRKS00013231).

KW - Chemotherapy, Adjuvant

KW - Counseling

KW - Diet, Healthy/methods

KW - Exercise Therapy/methods

KW - Feasibility Studies

KW - Female

KW - Humans

KW - Multicenter Studies as Topic

KW - Nutrition Therapy/methods

KW - Nutritional Status

KW - Ovarian Neoplasms/drug therapy

KW - Pilot Projects

KW - Randomized Controlled Trials as Topic

U2 - 10.1136/ijgc-2019-000585

DO - 10.1136/ijgc-2019-000585

M3 - SCORING: Journal article

C2 - 31796532

VL - 30

SP - 541

EP - 545

JO - INT J GYNECOL CANCER

JF - INT J GYNECOL CANCER

SN - 1048-891X

IS - 4

ER -