Predictors of duloxetine response in patients with neuropathic cancer pain: a secondary analysis of a randomized controlled trial—JORTC-PAL08 (DIRECT) study

Matsuoka, Hiromichi; Iwase, Satoru; Miyaji, Tempei; Kawaguchi, Takashi; Ariyoshi, Keisuke; Oyamada, Shunsuke; Satomi, Eriko; Ishiki, Hiroto; Hasuo, Hideaki; Sakuma, Hajime; Tokoro, Akihiro; Matsuda, Yoshinobu; Tahara, Keishiro; Otani, Hiroyuki; Ohtake, Yoichi; Tsukuura, Hiroaki; Matsumoto, Yoshihisa; Hasegawa, Yoshikazu; Kataoka, Yuki; Otsuka, Masatomo; Sakai, Kiyohiro; Nakura, Miki; Morita, Tatsuya; Yamaguchi, Takuhiro; Koyama, Atsuko

doi:10.1007/s00520-019-05138-9

Cited by 14 publications

(8 citation statements)

References 19 publications

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“…It is a 22-item questionnaire covering the domains of superficial and deep spontaneous pain, paroxysmal pain, evoked pain and paresthesia/dysaesthesia. We also used this tool in the pilot study that underpins the current trial15 16 and consider the possibility of effective pain types. This time it will be used to make a comparison for that verification.…”

Section: Methods and Analysismentioning

confidence: 99%

“…Although there is no standard first line treatment for NCP, a systematic review and meta-analysis suggested gabapentinoids be used first 13. Although there are few reports of duloxetine in NCP, Matsuoka et al have conducted a feasibility pretest and post-test14 and an RCT,15 16 which have shown the benefit of duloxetine (number needed to treat=3.4)15 and superiority for tingling pain 16. However, there are no RCTs of oral duloxetine for the management of opioid-refractory NCP.…”

Section: Introductionmentioning

confidence: 99%

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Phase III, international, multicentre, double-blind, dose increment, parallel-arm, randomised controlled trial of duloxetine versus pregabalin for opioid-unresponsive neuropathic cancer pain: a JORTC-PAL16 trial protocol

et al. 2022

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IntroductionManagement of neuropathic cancer pain (NCP) refractory to regular opioids remains an important challenge. The efficacy of pregabalin for NCP except chemotherapy-induced peripheral neuropathy (CIPN) has already been confirmed in two randomised controlled trials (RCTs) compared with placebo. Duloxetine offers the potential of analgesia in opioid refractory NCP. However, there are no RCT of duloxetine for the management of opioid-refractory NCP as a first line treatment. Both classes of drugs have the potential to reduce NCP, but there has been no head-to-head comparison for the efficacy and safety, especially given differing side effect profiles.Methods and analysisAn international, multicentre, double-blind, dose increment, parallel-arm, RCT is planned. Inclusion criteria include: adults with cancer experiencing NCP refractory to opioids; Brief Pain Inventory (BPI)-item 3 (worst pain) of ≥4; Neuropathic Pain on the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale of ≥12 despite of an adequate trial of regular opioid medication (≥60 mg/day oral morphine equivalent dose). Patients with CIPN are excluded.The study will recruit from palliative care teams (both inpatients and outpatients) in Japan and Australia. Participants will be randomised (1:1 allocation ratio) to duloxetine or pregabalin arm. Dose escalation is until day 14 and from day 14 to 21 is a dose de-escalation period to avoid withdrawal effects. The primary endpoint is defined as the mean difference in BPI item 3 for worst pain intensity over the previous 24 hours at day 14 between groups. A sample size of 160 patients will be enrolled between February 2020 and March 2023.Ethics and disseminationEthics approval was obtained at Osaka City University Hospital Certified Review Board and South Western Sydney Local Health District Human Research Ethics Committee. The results of this study will be submitted for publication in international journals and the key findings presented at international conferences.Trial registration numbersjRCTs051190097, ACTRN12620000656932.

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Section: Methods and Analysismentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Phase III, international, multicentre, double-blind, dose increment, parallel-arm, randomised controlled trial of duloxetine versus pregabalin for opioid-unresponsive neuropathic cancer pain: a JORTC-PAL16 trial protocol

et al. 2022

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“…27 Another randomized, double-blind placebo-controlled trial was conducted on 70 patients experiencing neuropathic pain secondary to cancer refractory to opioid and gabapentinoid treatment. 28 Seventy patients with a Brief Pain Inventory -Short Form (BPI-SF) of 4 or higher were included to participate in the study to receive placebo or duloxetine treatment. 28 Domains such as continuous pain, intermittent pain, neuropathic pain, and effective descriptors were studied, and results revealed that neuropathic pain showed significant change in pain scores in the duloxetine group from day 0 to 10.…”

Section: Duloxetinementioning

confidence: 99%

“…28 Seventy patients with a Brief Pain Inventory -Short Form (BPI-SF) of 4 or higher were included to participate in the study to receive placebo or duloxetine treatment. 28 Domains such as continuous pain, intermittent pain, neuropathic pain, and effective descriptors were studied, and results revealed that neuropathic pain showed significant change in pain scores in the duloxetine group from day 0 to 10. 28 Fibromyalgia is a somatic disorder that typically results in widespread musculoskeletal pain.…”

Section: Duloxetinementioning

confidence: 99%

A Look at Commonly Utilized Serotonin Noradrenaline Reuptake Inhibitors (SNRIs) in Chronic Pain

Robinson

Dalal

Chitneni

et al. 2022

Health Psychology Research

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Purpose of Review Chronic pain continues to be one of the leading healthcare cost burdens in the United States and is typically defined as ongoing pain, lasting longer than six months. Various treatment options exist for chronic pain, including physical therapy, medical management, pain psychology, and interventional therapies. Pain medications have been the mainstay of treatment for chronic pain conditions with an increasing use of membrane stabilizers and antidepressants to treat neuropathic pain conditions. Specifically, serotonin noradrenaline reuptake inhibitors (SNRIs) have been used to treat a range of pain conditions expanding from everyday use for depressive disorders. Recent Findings SNRIs, including duloxetine, venlafaxine, and milnacipran, have demonstrated efficacy in reducing pain in musculoskeletal pain (chronic low back pain and osteoarthritis), fibromyalgia, and neuropathic pain conditions (peripheral diabetic neuropathy). Summary The article describes the function, role, and use of SNRIs to treat chronic and neuropathic pain by altering the noradrenergic descending inhibitory pathways.

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“…Our recent studies (2,3) have also yielded different results within a single study, making interpretation difficult. One such study of ours, the DIRECT study, which was a multicenter double-blinded randomized placebo-controlled two-parallel group trial, investigated the efficacy of duloxetine for cancer-related neuropathic pain (CNP) nonresponsive or intolerant to opioidpregabalin combination therapy.…”

mentioning

confidence: 90%

Between-group difference in mean values or changes in pain intensity? Evaluating the distribution of change from baseline in a neuropathic cancer pain clinical trial

Matsuoka¹,

Morita²,

Oyamada³

et al. 2020

Ann Palliat Med

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Predictors of duloxetine response in patients with neuropathic cancer pain: a secondary analysis of a randomized controlled trial—JORTC-PAL08 (DIRECT) study

Cited by 14 publications

References 19 publications

Phase III, international, multicentre, double-blind, dose increment, parallel-arm, randomised controlled trial of duloxetine versus pregabalin for opioid-unresponsive neuropathic cancer pain: a JORTC-PAL16 trial protocol

Phase III, international, multicentre, double-blind, dose increment, parallel-arm, randomised controlled trial of duloxetine versus pregabalin for opioid-unresponsive neuropathic cancer pain: a JORTC-PAL16 trial protocol

A Look at Commonly Utilized Serotonin Noradrenaline Reuptake Inhibitors (SNRIs) in Chronic Pain

Between-group difference in mean values or changes in pain intensity? Evaluating the distribution of change from baseline in a neuropathic cancer pain clinical trial

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