Dexamethasone 8?mg for Cancer-Related Fatigue in Inpatients with Advanced Cancer Undergoing Palliative Care: A Multicenter Phase II Trial
Objective: No standard treatment for cancer-related fatigue (CRF) for inpatients in a palliative care setting exists. The aim of this study was to validate the previous study-derived efficacy of dexamethasone 8?mg for CRF among inpatients in a palliative care setting. Methods: Inpatients with modera...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Mary Ann Liebert
2021-11-01
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| Series: | Palliative Medicine Reports |
| Subjects: | |
| Online Access: | https://www.liebertpub.com/doi/full/10.1089/PMR.2021.0053 |
| _version_ | 1797346109844094976 |
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| author | Tomofumi Miura Ayumi Okizaki Hideaki Hasuo Eriko Satomi Keita Tagami Kengo Imai Takashi Kojima Hironaga Satake Hiroto Ishiki Akira Inoue Takuhiro Yamaguchi |
| author_facet | Tomofumi Miura Ayumi Okizaki Hideaki Hasuo Eriko Satomi Keita Tagami Kengo Imai Takashi Kojima Hironaga Satake Hiroto Ishiki Akira Inoue Takuhiro Yamaguchi |
| author_sort | Tomofumi Miura |
| collection | DOAJ |
| description | Objective: No standard treatment for cancer-related fatigue (CRF) for inpatients in a palliative care setting exists. The aim of this study was to validate the previous study-derived efficacy of dexamethasone 8?mg for CRF among inpatients in a palliative care setting.
Methods: Inpatients with moderate fatigue (?4/10) were enrolled in a multicenter phase II trial. Dexamethasone 8?mg p.o. or 6.6?mg i.v. was administered for seven days and 4?mg p.o. or 3.3?mg i.v. for seven consecutive days. The primary endpoint was a threshold average change of Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue subscale score of 3. The secondary endpoints were evaluated with the anorexia-cachexia subscale (ACS), and the Edmonton symptom assessment scale-revised Japanese version.
Results: A total of 32 patients were enrolled. On day 8, the mean change of FACIT-fatigue subscale from day 1 was 5.2 (95% confidence interval 0.8?10.0), in which the lower bound was above 0 but not above the prespecified threshold value of 3.0 (p?=?0.72). Edmonton symptom assessment system (ESAS)-fatigue was significantly improved by day 3 (p?=?0.02), but not on day 8 or day 15. ACS, physical well-being, and ESAS-lack of appetite significantly improved by day 8 and day 15. Adverse events were tolerable.
Conclusion: This study showed that dexamethasone 8?mg failed to achieve the preset efficacy for CRF among inpatients in a palliative care setting. However, this treatment improved fatigue and would be an option for CRF.
jRCT (jRCTs031180068). |
| first_indexed | 2024-03-08T11:28:14Z |
| format | Article |
| id | doaj.art-b266c5bc381a45c59fbc27289dff3790 |
| institution | Directory Open Access Journal |
| issn | 2689-2820 |
| language | English |
| last_indexed | 2024-03-08T11:28:14Z |
| publishDate | 2021-11-01 |
| publisher | Mary Ann Liebert |
| record_format | Article |
| series | Palliative Medicine Reports |
| spelling | doaj.art-b266c5bc381a45c59fbc27289dff37902024-01-26T04:57:01ZengMary Ann LiebertPalliative Medicine Reports2689-28202021-11-012131632310.1089/PMR.2021.0053Dexamethasone 8?mg for Cancer-Related Fatigue in Inpatients with Advanced Cancer Undergoing Palliative Care: A Multicenter Phase II TrialTomofumi MiuraAyumi OkizakiHideaki HasuoEriko SatomiKeita TagamiKengo ImaiTakashi KojimaHironaga SatakeHiroto IshikiAkira InoueTakuhiro YamaguchiObjective: No standard treatment for cancer-related fatigue (CRF) for inpatients in a palliative care setting exists. The aim of this study was to validate the previous study-derived efficacy of dexamethasone 8?mg for CRF among inpatients in a palliative care setting. Methods: Inpatients with moderate fatigue (?4/10) were enrolled in a multicenter phase II trial. Dexamethasone 8?mg p.o. or 6.6?mg i.v. was administered for seven days and 4?mg p.o. or 3.3?mg i.v. for seven consecutive days. The primary endpoint was a threshold average change of Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue subscale score of 3. The secondary endpoints were evaluated with the anorexia-cachexia subscale (ACS), and the Edmonton symptom assessment scale-revised Japanese version. Results: A total of 32 patients were enrolled. On day 8, the mean change of FACIT-fatigue subscale from day 1 was 5.2 (95% confidence interval 0.8?10.0), in which the lower bound was above 0 but not above the prespecified threshold value of 3.0 (p?=?0.72). Edmonton symptom assessment system (ESAS)-fatigue was significantly improved by day 3 (p?=?0.02), but not on day 8 or day 15. ACS, physical well-being, and ESAS-lack of appetite significantly improved by day 8 and day 15. Adverse events were tolerable. Conclusion: This study showed that dexamethasone 8?mg failed to achieve the preset efficacy for CRF among inpatients in a palliative care setting. However, this treatment improved fatigue and would be an option for CRF. jRCT (jRCTs031180068).https://www.liebertpub.com/doi/full/10.1089/PMR.2021.0053appetitecancer patientscancer-related fatiguedexamethasoneinpatientpalliative care |
| spellingShingle | Tomofumi Miura Ayumi Okizaki Hideaki Hasuo Eriko Satomi Keita Tagami Kengo Imai Takashi Kojima Hironaga Satake Hiroto Ishiki Akira Inoue Takuhiro Yamaguchi Dexamethasone 8?mg for Cancer-Related Fatigue in Inpatients with Advanced Cancer Undergoing Palliative Care: A Multicenter Phase II Trial Palliative Medicine Reports appetite cancer patients cancer-related fatigue dexamethasone inpatient palliative care |
| title | Dexamethasone 8?mg for Cancer-Related Fatigue in Inpatients with Advanced Cancer Undergoing Palliative Care: A Multicenter Phase II Trial |
| title_full | Dexamethasone 8?mg for Cancer-Related Fatigue in Inpatients with Advanced Cancer Undergoing Palliative Care: A Multicenter Phase II Trial |
| title_fullStr | Dexamethasone 8?mg for Cancer-Related Fatigue in Inpatients with Advanced Cancer Undergoing Palliative Care: A Multicenter Phase II Trial |
| title_full_unstemmed | Dexamethasone 8?mg for Cancer-Related Fatigue in Inpatients with Advanced Cancer Undergoing Palliative Care: A Multicenter Phase II Trial |
| title_short | Dexamethasone 8?mg for Cancer-Related Fatigue in Inpatients with Advanced Cancer Undergoing Palliative Care: A Multicenter Phase II Trial |
| title_sort | dexamethasone 8 mg for cancer related fatigue in inpatients with advanced cancer undergoing palliative care a multicenter phase ii trial |
| topic | appetite cancer patients cancer-related fatigue dexamethasone inpatient palliative care |
| url | https://www.liebertpub.com/doi/full/10.1089/PMR.2021.0053 |
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