Impact of Ninjin'Yoeito on Fatigue in Patients Receiving Nab-Paclitaxel Plus Gemcitabine Therapy: A Prospective, Single-Arm, Phase II Open Label, Nonrandomized, Historically-Controlled Study
ABSTRACT: Background: Ninjin'yoeito, a traditional Japanese herbal medicine, is used to prevent fatigue, loss of appetite, and coldness of limbs. Fatigue is an especially common issue during chemotherapy and can affect quality of life and the ability to complete scheduled treatment. Objectives...
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| Format: | Article |
| Language: | English |
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Elsevier
2020-01-01
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| Series: | Current Therapeutic Research |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S0011393X2030031X |
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| author | Ken-ichi Okada, MD, PhD Manabu Kawai, MD, PhD Seiko Hirono, MD, PhD Motoki Miyazawa, MD, PhD Yuji Kitahata, MD, PhD Ryohei Kobayashi, MD Masaki Ueno, MD, PhD Shinya Hayami, MD, PhD Toshio Shimokawa, PhD Hiroki Yamaue, MD, PhD |
| author_facet | Ken-ichi Okada, MD, PhD Manabu Kawai, MD, PhD Seiko Hirono, MD, PhD Motoki Miyazawa, MD, PhD Yuji Kitahata, MD, PhD Ryohei Kobayashi, MD Masaki Ueno, MD, PhD Shinya Hayami, MD, PhD Toshio Shimokawa, PhD Hiroki Yamaue, MD, PhD |
| author_sort | Ken-ichi Okada, MD, PhD |
| collection | DOAJ |
| description | ABSTRACT: Background: Ninjin'yoeito, a traditional Japanese herbal medicine, is used to prevent fatigue, loss of appetite, and coldness of limbs. Fatigue is an especially common issue during chemotherapy and can affect quality of life and the ability to complete scheduled treatment. Objectives: This prospective exploratory trial evaluates the efficacy of ninjin'yoeito for fatigue in patients undergoing nab-paclitaxel plus gemcitabine therapy for unresectable pancreatic cancer. The primary end point was evaluation of fatigue according to Functional Assessment of Chronic Illness Therapy-Fatigue score during 2 courses of nab-paclitaxel plus gemcitabine therapy. Secondary end points included evaluation of dose intensity, appetite loss using numerical rating scale, and peripheral neuropathy using a patient neurotoxicity questionnaire. Methods: We compared data from this interventional trial with a prior observational trial without administration of ninjin'yoeito with identical definition of end points (UMIN000021758). Thirty patients were required by the study. Results: Threshold mean of Functional Assessment of Chronic Illness Therapy-Fatigue score across 8 weeks during chemotherapy was under 5.3 (P = 0.002). Secondary end points did not reveal any specific patterns in appetite loss or degree of pain. No significant changes in patient neurotoxicity questionnaire concerning sensory/motor disorders were observed, but the mean (SD) incidence of patients with sensory disturbance was higher between the fifth and eighth weeks (8.8 [1.26]) than during the first and fourth weeks (4.8 [0.96]) (P = 0.003). Clinically significant adverse reactions of ninjin'yoeito were not observed. Conclusions: Ninjin'yoeito may be useful for improving the symptoms of fatigue caused by nab-paclitaxel plus gemcitabine in patients with unresectable pancreatic cancer. UMIN Clinical Trials Registry identifier: UMIN000025606. (Curr Ther Res Clin Exp. 2020; 81:XXX–XXX) |
| first_indexed | 2024-12-13T13:22:28Z |
| format | Article |
| id | doaj.art-1e255b8d75634d299ec54f14292c0ebd |
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| language | English |
| last_indexed | 2024-12-13T13:22:28Z |
| publishDate | 2020-01-01 |
| publisher | Elsevier |
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| series | Current Therapeutic Research |
| spelling | doaj.art-1e255b8d75634d299ec54f14292c0ebd2022-12-21T23:44:22ZengElsevierCurrent Therapeutic Research0011-393X2020-01-0193100605Impact of Ninjin'Yoeito on Fatigue in Patients Receiving Nab-Paclitaxel Plus Gemcitabine Therapy: A Prospective, Single-Arm, Phase II Open Label, Nonrandomized, Historically-Controlled StudyKen-ichi Okada, MD, PhD0Manabu Kawai, MD, PhD1Seiko Hirono, MD, PhD2Motoki Miyazawa, MD, PhD3Yuji Kitahata, MD, PhD4Ryohei Kobayashi, MD5Masaki Ueno, MD, PhD6Shinya Hayami, MD, PhD7Toshio Shimokawa, PhD8Hiroki Yamaue, MD, PhD9Second Department of Surgery, Wakayama Medical University, Wakayama, JapanSecond Department of Surgery, Wakayama Medical University, Wakayama, JapanSecond Department of Surgery, Wakayama Medical University, Wakayama, JapanSecond Department of Surgery, Wakayama Medical University, Wakayama, JapanSecond Department of Surgery, Wakayama Medical University, Wakayama, JapanSecond Department of Surgery, Wakayama Medical University, Wakayama, JapanSecond Department of Surgery, Wakayama Medical University, Wakayama, JapanSecond Department of Surgery, Wakayama Medical University, Wakayama, JapanClinical Study Support Center, Wakayama Medical University, Wakayama, JapanSecond Department of Surgery, Wakayama Medical University, Wakayama, Japan; Address correspondence to: Hiroki Yamaue, MD, PhD, Second Department of Surgery, Wakayama Medical University, 811-1 Kimiidera, Wakayama 641-8510, Japan.ABSTRACT: Background: Ninjin'yoeito, a traditional Japanese herbal medicine, is used to prevent fatigue, loss of appetite, and coldness of limbs. Fatigue is an especially common issue during chemotherapy and can affect quality of life and the ability to complete scheduled treatment. Objectives: This prospective exploratory trial evaluates the efficacy of ninjin'yoeito for fatigue in patients undergoing nab-paclitaxel plus gemcitabine therapy for unresectable pancreatic cancer. The primary end point was evaluation of fatigue according to Functional Assessment of Chronic Illness Therapy-Fatigue score during 2 courses of nab-paclitaxel plus gemcitabine therapy. Secondary end points included evaluation of dose intensity, appetite loss using numerical rating scale, and peripheral neuropathy using a patient neurotoxicity questionnaire. Methods: We compared data from this interventional trial with a prior observational trial without administration of ninjin'yoeito with identical definition of end points (UMIN000021758). Thirty patients were required by the study. Results: Threshold mean of Functional Assessment of Chronic Illness Therapy-Fatigue score across 8 weeks during chemotherapy was under 5.3 (P = 0.002). Secondary end points did not reveal any specific patterns in appetite loss or degree of pain. No significant changes in patient neurotoxicity questionnaire concerning sensory/motor disorders were observed, but the mean (SD) incidence of patients with sensory disturbance was higher between the fifth and eighth weeks (8.8 [1.26]) than during the first and fourth weeks (4.8 [0.96]) (P = 0.003). Clinically significant adverse reactions of ninjin'yoeito were not observed. Conclusions: Ninjin'yoeito may be useful for improving the symptoms of fatigue caused by nab-paclitaxel plus gemcitabine in patients with unresectable pancreatic cancer. UMIN Clinical Trials Registry identifier: UMIN000025606. (Curr Ther Res Clin Exp. 2020; 81:XXX–XXX)http://www.sciencedirect.com/science/article/pii/S0011393X2030031XFatigueJapanese herbal medicineNab-paclitaxel plus gemcitabineNinjin'yoeitoSupportive therapy |
| spellingShingle | Ken-ichi Okada, MD, PhD Manabu Kawai, MD, PhD Seiko Hirono, MD, PhD Motoki Miyazawa, MD, PhD Yuji Kitahata, MD, PhD Ryohei Kobayashi, MD Masaki Ueno, MD, PhD Shinya Hayami, MD, PhD Toshio Shimokawa, PhD Hiroki Yamaue, MD, PhD Impact of Ninjin'Yoeito on Fatigue in Patients Receiving Nab-Paclitaxel Plus Gemcitabine Therapy: A Prospective, Single-Arm, Phase II Open Label, Nonrandomized, Historically-Controlled Study Current Therapeutic Research Fatigue Japanese herbal medicine Nab-paclitaxel plus gemcitabine Ninjin'yoeito Supportive therapy |
| title | Impact of Ninjin'Yoeito on Fatigue in Patients Receiving Nab-Paclitaxel Plus Gemcitabine Therapy: A Prospective, Single-Arm, Phase II Open Label, Nonrandomized, Historically-Controlled Study |
| title_full | Impact of Ninjin'Yoeito on Fatigue in Patients Receiving Nab-Paclitaxel Plus Gemcitabine Therapy: A Prospective, Single-Arm, Phase II Open Label, Nonrandomized, Historically-Controlled Study |
| title_fullStr | Impact of Ninjin'Yoeito on Fatigue in Patients Receiving Nab-Paclitaxel Plus Gemcitabine Therapy: A Prospective, Single-Arm, Phase II Open Label, Nonrandomized, Historically-Controlled Study |
| title_full_unstemmed | Impact of Ninjin'Yoeito on Fatigue in Patients Receiving Nab-Paclitaxel Plus Gemcitabine Therapy: A Prospective, Single-Arm, Phase II Open Label, Nonrandomized, Historically-Controlled Study |
| title_short | Impact of Ninjin'Yoeito on Fatigue in Patients Receiving Nab-Paclitaxel Plus Gemcitabine Therapy: A Prospective, Single-Arm, Phase II Open Label, Nonrandomized, Historically-Controlled Study |
| title_sort | impact of ninjin yoeito on fatigue in patients receiving nab paclitaxel plus gemcitabine therapy a prospective single arm phase ii open label nonrandomized historically controlled study |
| topic | Fatigue Japanese herbal medicine Nab-paclitaxel plus gemcitabine Ninjin'yoeito Supportive therapy |
| url | http://www.sciencedirect.com/science/article/pii/S0011393X2030031X |
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