Effects of intermittent fasting on quality of life tolerance of chemotherapy in patients with gynecological cancers: study protocol of a randomized-controlled multi-center trial
Fatigue is a very common side effect during intravenous chemotherapy. Unfortunately, only few effective therapeutic options are available, mostly based on daily activity. In our pilot trial we were able to demonstrate that intermittent fasting can reduce fatigue in healthy people, thus we aimed to a...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-07-01
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| Series: | Frontiers in Oncology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fonc.2023.1222573/full |
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| author | Mona Wanda Schmidt Walburgis Brenner Susanne Gebhard Marcus Schmidt Susanne Singer Lina Weidenbach Harriett Hahn Diana Puzankova Bettina Blau-Schneider Antje Lehnert Marco Johannes Battista Katrin Almstedt Anja Lütkemeyer Markus Philipp Radsak Aline Mähringer-Kunz Slavomir Krajnak Valerie Cathrine Linz Roxana Schwab Boris Gabriel Annette Hasenburg Katharina Anic |
| author_facet | Mona Wanda Schmidt Walburgis Brenner Susanne Gebhard Marcus Schmidt Susanne Singer Lina Weidenbach Harriett Hahn Diana Puzankova Bettina Blau-Schneider Antje Lehnert Marco Johannes Battista Katrin Almstedt Anja Lütkemeyer Markus Philipp Radsak Aline Mähringer-Kunz Slavomir Krajnak Valerie Cathrine Linz Roxana Schwab Boris Gabriel Annette Hasenburg Katharina Anic |
| author_sort | Mona Wanda Schmidt |
| collection | DOAJ |
| description | Fatigue is a very common side effect during intravenous chemotherapy. Unfortunately, only few effective therapeutic options are available, mostly based on daily activity. In our pilot trial we were able to demonstrate that intermittent fasting can reduce fatigue in healthy people, thus we aimed to assess the effects of the fasting dietary on quality of life during chemotherapy in patients with gynecological cancer, especially on the domain of fatigue. The IFAST trial is designed as a prospective, randomized-controlled, multi-center trial. Participation will be offered to women with gynecological cancers (breast cancer, ovarian cancer including peritoneal and fallopian tube cancers, endometrial cancer and cervical cancer) who are planned to receive intravenous chemotherapy for at least three months. Eligible patients will be randomized 1:1, stratified by tumor type and study center. Primary endpoint is the difference in mean change in fatigue, assessed with the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT- FS©). Exploratory secondary endpoints will include general Quality of Life impairment, tolerance of chemotherapy, immunological changes, peripheral cell damage in blood cells, as well as tumor response to chemotherapy. There is new evidence that prolonged fasting periods of 46-96 hours during chemotherapy can positively influence the quality of life during chemotherapy. However, these fasting regiments are not feasible for many patients. Intermittent fasting could be a feasible (manageable) option for many patients to actively improve their quality of life and tolerance to chemotherapy and possibly even enhance the effectiveness of chemotherapy.Trial Registrationhttps://drks.de, identifier DRKS00031429. |
| first_indexed | 2024-03-12T23:02:44Z |
| format | Article |
| id | doaj.art-6474b128f3b1416b8f4dbe20fd706650 |
| institution | Directory Open Access Journal |
| issn | 2234-943X |
| language | English |
| last_indexed | 2024-03-12T23:02:44Z |
| publishDate | 2023-07-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Oncology |
| spelling | doaj.art-6474b128f3b1416b8f4dbe20fd7066502023-07-19T08:07:27ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2023-07-011310.3389/fonc.2023.12225731222573Effects of intermittent fasting on quality of life tolerance of chemotherapy in patients with gynecological cancers: study protocol of a randomized-controlled multi-center trialMona Wanda Schmidt0Walburgis Brenner1Susanne Gebhard2Marcus Schmidt3Susanne Singer4Lina Weidenbach5Harriett Hahn6Diana Puzankova7Bettina Blau-Schneider8Antje Lehnert9Marco Johannes Battista10Katrin Almstedt11Anja Lütkemeyer12Markus Philipp Radsak13Aline Mähringer-Kunz14Slavomir Krajnak15Valerie Cathrine Linz16Roxana Schwab17Boris Gabriel18Annette Hasenburg19Katharina Anic20Department of Gynecology and Obstetrics, University Medical Center of Johannes Gutenberg University of Mainz, Mainz, GermanyDepartment of Gynecology and Obstetrics, Management of the Scientific laboratories, University Medical Center of Johannes Gutenberg University of Mainz, Mainz, GermanyDepartment of Gynecology and Obstetrics, Management of the Scientific laboratories, University Medical Center of Johannes Gutenberg University of Mainz, Mainz, GermanyDepartment of Gynecology and Obstetrics, University Medical Center of Johannes Gutenberg University of Mainz, Mainz, GermanyDivision of Epidemiology and Health Services Research, Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Center of Johannes Gutenberg University of Mainz, Mainz, GermanyDepartment of Gynecology and Obstetrics, University Medical Center of Johannes Gutenberg University of Mainz, Mainz, GermanyDepartment of Gynecology and Obstetrics, University Medical Center of Johannes Gutenberg University of Mainz, Mainz, GermanyDepartment of Gynecology and Obstetrics, University Medical Center of Johannes Gutenberg University of Mainz, Mainz, GermanyDepartment of Obstetrics and Gynecology, St. Josefs Hospital Wiesbaden Academic Teaching Hospital, Wiesbaden, GermanyDepartment of Obstetrics and Gynecology, St. Josefs Hospital Wiesbaden Academic Teaching Hospital, Wiesbaden, GermanyDepartment of Gynecology and Obstetrics, University Medical Center of Johannes Gutenberg University of Mainz, Mainz, GermanyDepartment of Gynecology and Obstetrics, University Medical Center of Johannes Gutenberg University of Mainz, Mainz, GermanyDepartment of Gynecology and Obstetrics, University Medical Center of Johannes Gutenberg University of Mainz, Mainz, GermanyIIIrd Department of Medicine, Medical Center of the Johannes Gutenberg-University of Mainz, Mainz, GermanyDepartment of Radiology, University Medical Center of Johannes Gutenberg University of Mainz, Mainz, GermanyDepartment of Gynecology and Obstetrics, University Medical Center of Johannes Gutenberg University of Mainz, Mainz, GermanyDepartment of Gynecology and Obstetrics, University Medical Center of Johannes Gutenberg University of Mainz, Mainz, GermanyDepartment of Gynecology and Obstetrics, University Medical Center of Johannes Gutenberg University of Mainz, Mainz, GermanyDivision of Epidemiology and Health Services Research, Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Center of Johannes Gutenberg University of Mainz, Mainz, GermanyDepartment of Gynecology and Obstetrics, University Medical Center of Johannes Gutenberg University of Mainz, Mainz, GermanyDepartment of Gynecology and Obstetrics, University Medical Center of Johannes Gutenberg University of Mainz, Mainz, GermanyFatigue is a very common side effect during intravenous chemotherapy. Unfortunately, only few effective therapeutic options are available, mostly based on daily activity. In our pilot trial we were able to demonstrate that intermittent fasting can reduce fatigue in healthy people, thus we aimed to assess the effects of the fasting dietary on quality of life during chemotherapy in patients with gynecological cancer, especially on the domain of fatigue. The IFAST trial is designed as a prospective, randomized-controlled, multi-center trial. Participation will be offered to women with gynecological cancers (breast cancer, ovarian cancer including peritoneal and fallopian tube cancers, endometrial cancer and cervical cancer) who are planned to receive intravenous chemotherapy for at least three months. Eligible patients will be randomized 1:1, stratified by tumor type and study center. Primary endpoint is the difference in mean change in fatigue, assessed with the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT- FS©). Exploratory secondary endpoints will include general Quality of Life impairment, tolerance of chemotherapy, immunological changes, peripheral cell damage in blood cells, as well as tumor response to chemotherapy. There is new evidence that prolonged fasting periods of 46-96 hours during chemotherapy can positively influence the quality of life during chemotherapy. However, these fasting regiments are not feasible for many patients. Intermittent fasting could be a feasible (manageable) option for many patients to actively improve their quality of life and tolerance to chemotherapy and possibly even enhance the effectiveness of chemotherapy.Trial Registrationhttps://drks.de, identifier DRKS00031429.https://www.frontiersin.org/articles/10.3389/fonc.2023.1222573/fullintermittent fastingquality of lifefatiguegynecological cancerschemotherapy |
| spellingShingle | Mona Wanda Schmidt Walburgis Brenner Susanne Gebhard Marcus Schmidt Susanne Singer Lina Weidenbach Harriett Hahn Diana Puzankova Bettina Blau-Schneider Antje Lehnert Marco Johannes Battista Katrin Almstedt Anja Lütkemeyer Markus Philipp Radsak Aline Mähringer-Kunz Slavomir Krajnak Valerie Cathrine Linz Roxana Schwab Boris Gabriel Annette Hasenburg Katharina Anic Effects of intermittent fasting on quality of life tolerance of chemotherapy in patients with gynecological cancers: study protocol of a randomized-controlled multi-center trial Frontiers in Oncology intermittent fasting quality of life fatigue gynecological cancers chemotherapy |
| title | Effects of intermittent fasting on quality of life tolerance of chemotherapy in patients with gynecological cancers: study protocol of a randomized-controlled multi-center trial |
| title_full | Effects of intermittent fasting on quality of life tolerance of chemotherapy in patients with gynecological cancers: study protocol of a randomized-controlled multi-center trial |
| title_fullStr | Effects of intermittent fasting on quality of life tolerance of chemotherapy in patients with gynecological cancers: study protocol of a randomized-controlled multi-center trial |
| title_full_unstemmed | Effects of intermittent fasting on quality of life tolerance of chemotherapy in patients with gynecological cancers: study protocol of a randomized-controlled multi-center trial |
| title_short | Effects of intermittent fasting on quality of life tolerance of chemotherapy in patients with gynecological cancers: study protocol of a randomized-controlled multi-center trial |
| title_sort | effects of intermittent fasting on quality of life tolerance of chemotherapy in patients with gynecological cancers study protocol of a randomized controlled multi center trial |
| topic | intermittent fasting quality of life fatigue gynecological cancers chemotherapy |
| url | https://www.frontiersin.org/articles/10.3389/fonc.2023.1222573/full |
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