Published Papers - Nakajima Nobuhisa

Effectiveness of rapid titration with intravenous administration of oxycodone injection in advanced cancer patients with severe pain.

Nakajima N

Japanese journal of clinical oncology ( Japanese Journal of Clinical Oncology )  49 ( 11 ) 1061 - 1064   2019.12 [ Peer Review Accepted ]

Type of publication: Research paper (scientific journal)

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Some cancer patients suddenly develop severe, excruciating pain that requires rapid management using opioid medication. This study aimed to evaluate the effectiveness of rapid titration using oxycodone injection. Study subjects were advanced cancer patients who experienced severe pain (numeric rating scale ≥7) and needed prompt pain relief. Primary endpoint was (i) time required for the initial sign of significant analgesia to become evident. Secondary endpoints were (ii) pain relief stabilization success rate and (iii) adverse effects. Groups treated with oxycodone (oxycodone group) and morphine (morphine group) were retrospectively compared. The oxycodone group had 33 cases and the morphine group had 32 cases: (i) 15.6 ± 4.3 min in the oxycodone group and 19.3 ± 4.7 min in the morphine group (P = 0.001); (ii) 70 and 63% within 24 hours, and 88 and 84% within 48 hours in the oxycodone group and the morphine group, respectively (P = 0.36, 0.48). Although (iii) adverse effects appeared in both groups in the form of respiratory suppression, etc., the effects were mild. Rapid titration using oxycodone injections may be considered a beneficial choice.

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A pilot survey on the outpatient chemotherapy unit of national university hospitals in Japan for early palliative care

Takahashi, H; Satomi, Y; Suzuki, T; Uneoka, S; Ishii, T; Nanba, A; Iguchi, N; Takemura, K; Nakajima, N; Masuda, M; Arasaki, A

ANNALS OF ONCOLOGY   30   2019.10 [ Peer Review Accepted ]

Type of publication: Research paper (scientific journal)

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Clinical Guidelines for Management of Gastrointestinal Symptoms in Cancer Patients: The Japanese Society of Palliative Medicine Recommendations.

Hisanaga T, Shinjo T, Imai K, Katayama K, Kaneishi K, Honma H, Takagaki N, Osaka I, Matsuo N, Kohara H, Yamaguchi T, Nakajima N

Journal of palliative medicine ( Journal of Palliative Medicine )  22 ( 8 ) 986 - 997   2019.08 [ Peer Review Accepted ]

Type of publication: Research paper (scientific journal)

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Background: Gastrointestinal symptoms, including nausea, vomiting, bowel obstruction, ascites, constipation, and anorexia, are common and often refractory in advanced cancer patients. The palliation of gastrointestinal symptoms is important in improving the quality of life of cancer patients, as well as that of their families and caregivers. Currently published clinical guidelines for the management of gastrointestinal symptoms in cancer patients do not comprehensively cover the topics or are not based on a formal process for the development of clinical guidelines. Methods: The Japanese Society for Palliative Medicine (JSPM) developed comprehensive clinical guidelines for the management of gastrointestinal symptoms in cancer patients after a formal guideline development process. Results: This article summarizes the recommendations along with their rationale and a short summary of the development process of the JSPM gastrointestinal symptom management guidelines. We established 31 recommendations, all of which are based on the best available evidence and agreement of expert taskforce members. Discussion: Future clinical studies and continuous guideline updates are required to improve gastrointestinal symptom management in cancer patients.

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Current pharmacotherapy does not improve severity of hypoactive delirium in patients with advanced cancer: pharmacological audit study of safety and efficacy in real world (Phase-R)

Okuyama T, Yoshiuchi K, Ogawa A, Phase-R group (Nakajima N, et al)

Oncologist   24 ( 7 ) 574 - 582   2019.07 [ Peer Review Accepted ]

Type of publication: Research paper (scientific journal)

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Treatment Recommendations for Urological Symptoms in Cancer Patients: Clinical Guidelines from the Japanese Society for Palliative Medicine.

Tsushima T, Miura T, Hachiya T, Nakamura I, Yamato T, Kishida T, Tanaka Y, Irie S, Meguro N, Kawahara T, Nakajima N

Journal of palliative medicine ( Journal of Palliative Medicine )  22 ( 1 ) 54 - 61   2019.01 [ Peer Review Accepted ]

Type of publication: Research paper (scientific journal)

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BACKGROUND: Urological symptoms such as gross hematuria, lower and upper urinary tract symptoms, and bladder pain are common in and distressing for patients with advanced cancer. Although palliation of urological symptoms is important to improve the quality of life of cancer patients and their families and caregivers, clinical guidelines for managing urological symptoms in patients with cancer have not been published. METHODS: Following the formal guideline development process, the Japanese Society for Palliative Medicine (JSPM) developed comprehensive clinical guidelines for the management of urological symptoms in patients with cancer. RESULTS: This article summarizes the recommendations and their rationales and provides a short summary of the development process of the JSPM urological symptom management guidelines. We established five recommendations, all of which were based on the best available evidence and expert consensus. CONCLUSION: JSPM released the first edition of the "Clinical Guidelines for Urological Symptoms in Cancer Patients." Future clinical research and continuous guideline updates are required to improve the quality of managing urological symptoms in patients with cancer.

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Low Transthyretin Levels Predict Poor Prognosis in Cancer Patients in Palliative Care Settings.

Miura T, Amano K, Shirado A, Baba M, Ozawa T, Nakajima N, Suga A, Matsumoto Y, Shimizu M, Shimoyama S, Kuriyama T, Matsuda Y, Iwashita T, Mori I, Kinoshita H

Nutrition and cancer ( Nutrition and Cancer )  70 ( 8 ) 1283 - 1289   2018.11 [ Peer Review Accepted ]

Type of publication: Research paper (scientific journal)

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Objectives: Although transthyretin (TTR) is a nutritional indicator and is influenced by systemic inflammation, it may be a good prognostic indicator for cancer patients in palliative care settings. This study investigates the correlation between low TTR levels and survival among cancer patients in palliative care settings.Methods: This was a sub-analysis of a prospective, multicenter cohort study. Patients who had advanced-stage cancer and who were newly referred to palliative care services were eligible to participate; however, those receiving anti-tumor therapy were excluded. Survival analyses were performed to clarify predictors of poor prognosis.Results: A total of 144 patients were enrolled (45.1% female; median age, 72years). Cox regression analysis revealed that low TTR levels (<10.9mg/l) (hazard ratio 1.74, P=0.025), poor muscle power (1.71, P=0.045), and fatigue (1.89, P=0.024) were predictors of poor prognosis. Median survival in patients with low TTR levels (<10.9mg/l) was 26days, which was significantly shorter than those with high TTR levels (10.9mg/l) (50days; P<0.001).Conclusion: Low TTR levels may be indicators for poor prognosis among cancer patients in palliative care settings.

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C-reactive protein, symptoms and activity of daily living in patients with advanced cancer receiving palliative care.

Amano K, Maeda I, Morita T, Baba M, Miura T, Hama T, Mori I, Nakajima N, Nishi T, Sakurai H, Shimoyama S, Shinjo T, Shirayama H, Yamada T, Ono S, Ozawa T, Yamamoto R, Yamamoto N, Shishido H, Kinoshita H

Journal of cachexia, sarcopenia and muscle   8 ( 3 ) 457 - 465   2017.06 [ Peer Review Accepted ]

Type of publication: Research paper (scientific journal)

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BACKGROUND: The association between C-reactive protein (CRP) level, symptoms, and activities of daily living (ADL) in advanced cancer patients is unclear. METHODS: Secondary data analysis of a multicenter prospective cohort study consisted of 2426 advanced cancer patients referred to palliative care settings was conducted to examine the cross-sectional relationships between CRP level, symptoms, and ADL disabilities. Laboratory data, symptoms, ADL, and manual muscle testing (MMT) results were obtained at baseline. Participants were divided into four groups: low (CRP < 1 mg/dl), moderate (1 = < CRP <5 mg/dl), high (5 = < CRP < 10 mg/dl), and very high CRP (10 mg/dl = < CRP). The proportions of eight symptoms, five ADL disabilities, and three categories of MMT according to the CRP groups were tested by chi-square tests. Multiple-adjusted odd ratios (ORs) were calculated by using ordinal logistic regression after adjustment for age, gender, site of primary cancer, metastatic disease, performance status, chemotherapy, and setting of care. RESULTS: A total of 1702 patients were analysed. Positive rates of symptoms and ADL disabilities increased with increasing CRP level. In the very high-CRP group, rates of positivity for anorexia, fatigue, and weight loss were 89.8%, 81.0%, and 79.2%, respectively, and over 70% of patients received assistance for bathing, dressing, going to the toilet, and transfer. The grade of MMT also deteriorated with increasing CRP level. Adjusted ORs for the accumulated symptoms significantly increased with increasing CRP level in the moderate-CRP, high-CRP, and very high-CRP groups [1.6 (95% confidence interval 1.2-2.0), P < 0.001; 2.5 (1.9-3.2), P < 0.001; 3.5 (2.7-4.6), P < 0.001, respectively]. Adjusted ORs for the accumulated ADL disabilities significantly increased in the very high-CRP groups [2.1 (1.5-2.9), P < 0.001]. CONCLUSIONS: Associations between CRP level, symptoms, and ADL were observed in advanced cancer patients receiving palliative care.

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Characteristics of Oral Problems and Effects of Oral Care in Terminally Ill Patients With Cancer.

Nakajima N

The American journal of hospice & palliative care   34 ( 5 ) 430 - 434   2017.06 [ Peer Review Accepted ]

Type of publication: Research paper (scientific journal)

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PURPOSE: Various distresses appear in the terminal stage of cancer. Oral problems including dry mouth, stomatitis and candidiasis are one of the important problems which should be resolved. The purpose of this study was to investigate oral problems in this stage and improvement of dry mouth by oral care. METHODS: The study subjects were consecutive terminally ill cancer patients admitted over the past 2 years. Patients were divided based on the status of oral food intake into good oral food intake group (≥30%) and poor oral food intake group. The following 3 items were retrospectively investigated: 1) The incidences of these oral problems, 2) Severity of dry mouth and complication with other oral problems, 3) Improvement of dry mouth using standard oral care by nursing staff and specialist oral care including dentists as needed. RESULTS: There were 115 and 158 patients in good and poor oral intake groups, respectively. 1) The incidences of dry mouth, stomatitis, and candidiasis were significantly higher in poor oral intake group ( p < 0.001). 2) Severe cases of dry mouth (Grade-2&3) were noted in 20.0% and 64.8% in good and poor oral intake groups, respectively ( p < 0.0001). Candidiasis complication rate was significantly higher in poor oral intake group ( p = 0.0002). 3) The rate of dry mouth improvement by oral care was 100% in Grade-1, 86% in Grade-2 and 81% in Grade-3. CONCLUSION: Oral problems occur in many of terminally ill cancer patients. Accurate diagnosis of oral problems and corresponding appropriate interventions are important for improving quality of end-of-life care.

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The Predictive Risk Factors for Bedsores of Terminal Cancer Patients Receiving Home-based Care

Nishizaki Hisayoshi, Ishikawa Natsue, Hirayama Hideyuki, Miyashita Mitsunori, Nakajima Nobuhisa

Palliative Care Research ( Japanese Society for Palliative Medicine )  12 ( 3 ) 271 - 276   2017 [ Peer Review Accepted ]

Type of publication: Research paper (other science council materials etc.)

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<p>Aim: To clarify the predictive risk factors for bedsores of terminal cancer patients receiving home-based care. Methods: A retrospective study was conducted involving 95 terminal cancer patients receiving home-based care, including people using services provided by home-visit care providers until death. Results: The numbers of patients with and without bedsores were 31 and 64, respectively. Bivariate analyses revealed that significant variables were the Ohura-Hotta scale (P=0.02), hyperactive delirium (P=0.005), contracture (P=0.008), and anemia (P=0.02). According to multivariable logistic analysis, significant variables were contracture (OR=16.55, P=0.0002) and hyperactive delirium (OR=4.22, P=0.008) as independent risk factors for bedsores. Discussion: For terminal cancer patients receiving home-based care, hyperactive delirium should also be considered as a predictive risk factor for bedsores.</p>

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Guidelines for parenteral fluid management for terminal cancer patients.

Higashiguchi T, Ikegaki J, Sobue K, Tamura Y, Nakajima N, Futamura A, Miyashita M, Mori N, Inui A, Ohta K, Hosokawa T

Japanese journal of clinical oncology   46 ( 11 ) 986 - 992   2016.11 [ Peer Review Accepted ]

Type of publication: Research paper (scientific journal)

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BACKGROUND: Japan's first guidelines for parenteral fluid management for terminal cancer patients were issued in 2006. These guidelines focused on the fluid levels to administer to patients with a remaining life expectancy of 1-2 months. However, recent refinement of the concept of cachexia is prompting caregivers worldwide to rethink parenteral fluid management for terminal cancer patients. OBJECTIVE: Our objective was to develop guidelines for parenteral fluid management for terminal cancer patients with a remaining life expectancy of 1 month, a point when cachexia generally begins to severely adversely affect the body. METHODS: The Japanese Society for Palliative Medicine appointed a Guidelines Working Practitioner Group consisting of a multidisciplinary team of specialists. In response to 26 clinical questions on parenteral fluid management for terminal cancer patients, the Working Group used the Delphi method to reach consensus on the recommendability and evidence level of 89 relevant manuscripts identified through a systematic literature review. The Working Group then had an outside committee reviews the draft guidelines validity before authoring the final version. RESULTS: The resulting clinically aligned guidelines contain specific recommendations (25 recommendations on physical suffering/remaining life expectancy, 10 nursing-related recommendations and 4 ethical recommendations) assessed using the Delphi method and by an outside committee. CONCLUSIONS: Japanese Society for Palliative Medicine released a revised edition of the Guidelines for Parenteral Fluid Management for Terminal Cancer Patients, which are based on medical evidence and consider the pathologic features of cachexia. We recommend that caregivers carefully evaluate the clinical usefulness of the guidelines.

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Multicenter cohort study on the survival time of cancer patients dying at home or in a hospital: Does place matter?

Hamano J, Yamaguchi T, Maeda I, Suga A, Hisanaga T, Ishihara T, Iwashita T, Kaneishi K, Kawagoe S, Kuriyama T, Maeda T, Mori I, Nakajima N, Nishi T, Sakurai H, Shimoyama S, Shinjo T, Shirayama H, Yamada T, Morita T

Cancer   122 ( 9 ) 1453 - 60   2016.05 [ Peer Review Accepted ]

Type of publication: Research paper (scientific journal)

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BACKGROUND: Although the place of death has a great influence on the quality of death and dying for cancer patients, whether the survival time differs according to the place of death is unclear. The primary aim of this study was to explore potential differences in the survival time of cancer patients dying at home or in a hospital. METHODS: This multicenter, prospective cohort study was conducted in Japan from September 2012 through April 2014 and involved 58 specialist palliative care services. RESULTS: Among the 2426 patients recruited, 2069 patients were analyzed for this study: 1582 receiving hospital-based palliative care and 487 receiving home-based palliative care. A total of 1607 patients actually died in a hospital, and 462 patients died at home. The survival of patients who died at home was significantly longer than the survival of patients who died in a hospital in the days' prognosis group (estimated median survival time, 13 days [95% confidence interval (CI), 10.3-15.7 days] vs 9 days [95% CI, 8.0-10.0 days]; P = .006) and in the weeks' prognosis group (36 days [95% CI, 29.9-42.1 days] vs 29 days [95% CI, 26.5-31.5 days]; P = .007) as defined by Prognosis in Palliative Care Study predictor model A. No significant difference was identified in the months' prognosis group. Cox proportional hazards analysis revealed that the place of death had a significant influence on the survival time in both unadjusted (hazard ratio [HR], 0.86; 95% CI, 0.78-0.96; P < .01) and adjusted models (HR, 0.87; 95% CI, 0.77-0.97; P = .01). CONCLUSIONS: In comparison with cancer patients who died in a hospital, cancer patients who died at home had similar or longer survival. Cancer 2016;122:1453-1460. © 2016 American Cancer Society.

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Concurrent Specialized Palliative Care Upon Initiation of First-Line Chemotherapy for Cancer Progression: Is It Early Enough?

Nakajima N, Abe Y

The American journal of hospice & palliative care   33 ( 4 ) 340 - 5   2016.05 [ Peer Review Accepted ]

Type of publication: Research paper (scientific journal)

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PURPOSE: To evaluate the effectiveness of specialized palliative care (PC) administered at the time of administration of first-line chemotherapy for cancer progression. METHODS: Patients who received regular specialist PC concomitantly with first-line chemotherapy after being diagnosed with progressive disease assigned to PC group. Patients transferred to palliative care unit (PCU) after discontinuation of chemotherapy were assigned to standard care (SC) group. We evaluated quality of palliative care using Support Team Assessment Schedule, quality of life (QOL) using Good Death Inventory, and short-term mortality in PCU. RESULTS: A total of 28 and 63 patients patients were assigned to PC and SC groups, respectively. Physical symptoms, anxiety, communication scores, and QOL scores were significantly higher in the PC group (P < .001). Short-term mortality (<14 days) was significantly higher in the SC group (P = .0005). CONCLUSION: This approach may facilitate high quality of PC.

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Does the Approach of Disclosing More Detailed Information of Cancer for the Terminally Ill Patients Improve the Quality of Communication Involving Patients, Families, and Medical Professionals?

Nakajima N, Kusumoto K, Onishi H, Ishida M

The American journal of hospice & palliative care   32 ( 7 ) 776 - 82   2015.11 [ Peer Review Accepted ]

Type of publication: Research paper (scientific journal)

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PURPOSE: Effective and faithful communication between patients and medical professionals could improve patients' quality of life and is an essential and fundamental factor in cancer treatment. The purpose of this study was to examine whether disclosing more detailed information about disease progression toterminally ill patients could improve the quality of communication. METHODS: This was a before/after study of 91 consecutive terminal cancer patients. Based on the previous studies, we categorized cancer disclosure into 4 groups: A;"non-disclosure", B;"disclosure of cancer diagnosis", C;"disclosureof life-threatening disease", and D;"disclosure of poor prognosis". We disclosed more detailed information based on the SPIKES protocol and compared the scores of 3 communication items of Support Team Assessment Schedule (Japanese version) measured between at admission and one-week after this approach. RESULTS: A, B, C and D groups included 8, 25, 40, and 18 cases, respectively. This approach to cancer disclosure was implemented in 37.5% of group A, 60% of group B, and 40% of group C. In group B, all 3 communications were significantly improved (2.40 ± 0.51 vs 1.53 ± 0.83, 1.93 ± 0.96 vs 1.00 ± 0.38, 2.13 ± 0.64 vs 1.13 ± 0.64; p = 0.0035, 0.0062, 0.0013). In group C, all 3 communications were significantly improved (1.25 ± 0.58 vs 0.81 ± 0.66, 1.13 ± 0.34 vs 0.69 ± 0.48, 1.31±0.60 vs 0.56 ± 0.63; p = 0.020, 0.0082, 0.0057). CONCLUSIONS: This study revealed that disclosing more detailed information of cancer for terminally ill cancer patients contributed to improving the quality of communication, irrespective of the stage of disclosure.

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Glasgow prognostic score predicts prognosis for cancer patients in palliative settings: a subanalysis of the Japan-prognostic assessment tools validation (J-ProVal) study.

Miura T, Matsumoto Y, Hama T, Amano K, Tei Y, Kikuchi A, Suga A, Hisanaga T, Ishihara T, Abe M, Kaneishi K, Kawagoe S, Kuriyama T, Maeda T, Mori I, Nakajima N, Nishi T, Sakurai H, Morita T, Kinoshita H

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer   23 ( 11 ) 3149 - 56   2015.11 [ Peer Review Accepted ]

Type of publication: Research paper (scientific journal)

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PURPOSE: The Glasgow prognostic score (GPS), which uses C-reactive protein and albumin levels, is a good predictor of prognosis in cancer patients undergoing anti-tumor therapy. The objective of this study was to investigate the correlation between GPS and survival among cancer patients in palliative settings, as findings in such populations have not been well described. METHODS: This was a subanalysis of a multicenter, prospective, cohort study in patients who were adults, diagnosed with advanced cancer, and first referred to palliative care service in Japan. Patients who were not receiving anti-tumor therapy and who had undergone laboratory examinations were eligible. Clinical features were analyzed to investigate prognostic factors. RESULTS: A total of 1160 patients were enrolled (41.6 % female; median age, 72 years). The independent predictors were Eastern Cooperative Oncology Group performance status (ECOG PS) score of 4 (hazard ratio (HR), 1.54), liver metastasis (HR, 1.21), dyspnea (HR, 1.35), edema (HR, 1.25), prognostic performance index (HR, 1.56), neutrophil-lymphocyte ratio (HR, 1.43), and GPS of 2 (HR, 1.36). The sensitivity and specificity for 3-week prognosis of a GPS of 2 were 0.879 and 0.410. Median survival time with GPS of 0, 1, and 2 was 58 days (95 % confidence interval, 48-81), 43 days (37-50), and 21 days (19-24), respectively (log-rank test, p < 0.001). CONCLUSION: The GPS was a good prognostic indicator for cancer patients in palliative settings.

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Independent validation of the modified prognosis palliative care study predictor models in three palliative care settings.

Baba M, Maeda I, Morita T, Hisanaga T, Ishihara T, Iwashita T, Kaneishi K, Kawagoe S, Kuriyama T, Maeda T, Mori I, Nakajima N, Nishi T, Sakurai H, Shimoyama S, Shinjo T, Shirayama H, Yamada T, Ono S, Ozawa T, Yamamoto R, Tsuneto S

Journal of pain and symptom management   49 ( 5 ) 853 - 60   2015.05 [ Peer Review Accepted ]

Type of publication: Research paper (scientific journal)

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CONTEXT: Accurate prognostic information in palliative care settings is needed for patients to make decisions and set goals and priorities. The Prognosis Palliative Care Study (PiPS) predictor models were presented in 2011, but have not yet been fully validated by other research teams. OBJECTIVES: The primary aim of this study is to examine the accuracy and to validate the modified PiPS (using physician-proxy ratings of mental status instead of patient interviews) in three palliative care settings, namely palliative care units, hospital-based palliative care teams, and home-based palliative care services. METHODS: This multicenter prospective cohort study was conducted in 58 palliative care services including 16 palliative care units, 19 hospital-based palliative care teams, and 23 home-based palliative care services in Japan from September 2012 through April 2014. RESULTS: A total of 2426 subjects were recruited. For reasons including lack of followup and missing variables (primarily blood examination data), we obtained analyzable data from 2212 and 1257 patients for the modified PiPS-A and PiPS-B, respectively. In all palliative care settings, both the modified PiPS-A and PiPS-B identified three risk groups with different survival rates (P<0.001). The absolute agreement ranged from 56% to 60% in the PiPS-A model and 60% to 62% in the PiPS-B model. CONCLUSION: The modified PiPS was successfully validated and can be useful in palliative care units, hospital-based palliative care teams, and home-based palliative care services.

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