Effect of Pregabalin on Radiotherapy-Related Neuropathic Pain in Patients With Head and Neck Cancer: A Randomized Controlled Trial

Jiang, Jingru; Li, Yang; Shen, Qingyu; Rong, Xiaoming; Huang, Xiaolong; Li, Honghong; Zhou, Lizhi; Qiang, Hai; Zheng, Dong; Chen, Ming Yuan; Xu, Yongteng; Li, Jibin; Hui, Xuan; Simone, Charles B.; Gaertner, Jan; Chow, Edward; Chen, Pingyan; Tang, Yamei

doi:10.1200/jco.18.00896

Cited by 36 publications

(45 citation statements)

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“…Four RCTs testing the effect of pregabalin [ 10 , 12 , 14 , 15 ] and two RCTs testing the effect of mirogabalin [ 11 , 13 ] were included in the meta-analysis. The combined NNT using a random-effects model was 8.40 (4.85; 31.15) (test for heterogeneity: χ 2 = 24.2; d f = 5; P =0.0002; I 2 = 79.32%) ( Figure 2(b) .…”

Section: Resultsmentioning

confidence: 99%

Pharmacotherapeutic Options for Managing Neuropathic Pain: A Systematic Review and Meta-Analysis

Stefano

Lionardo

Pietro

et al. 2021

Pain Research and Management

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Despite an increasing number of available therapies, the treatment of neuropathic pain remains a major issue. Systematic reviews and meta-analyses indicate that only a minority of patients with neuropathic pain have an adequate response to pharmacological treatment and that most drugs have dose-limiting side effects. We conducted a systematic review and meta-analysis of randomised controlled trials published in the last five years. We searched for relevant papers within PubMed, EMBASE, the Cochrane Database of Systematic Reviews, and the Clinical Trials database (ClinicalTrials.gov). Two authors independently selected studies for inclusion, data extraction, and bias assessment. We identified 39 randomised controlled trials and included 16 in the meta-analysis. Trial outcomes were generally modest even for first-line drugs such as tricyclic antidepressants, serotonin-noradrenaline reuptake inhibitors, and gabapentinoids. Many drugs acting on new pain targets are currently under development. Clinical data are currently available for sodium channel isoform-specific antagonists, anti-nerve growth factor molecules, and fatty acid amide hydrolase inhibitors.

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Section: Resultsmentioning

confidence: 99%

Pharmacotherapeutic Options for Managing Neuropathic Pain: A Systematic Review and Meta-Analysis

Stefano

Lionardo

Pietro

et al. 2021

Pain Research and Management

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“…An opioid crisis also looms over North America with thousands of lives being claimed to opioid misuse, addiction, and overdose [13]. Importantly, neuropathic pain does not respond effectively to opioid therapy and often requires escalating doses, thereby exacerbating opioid side effects [17][18][19][20].…”

Section: Introductionmentioning

confidence: 99%

“…Few studies have explored the role Gabapentinoids play in treating radiation-induced neuropathic pain. A randomized double-blinded placebo-controlled clinical trial by Jiang et al established that in HNC patients who suffered from chronic radiotherapy-related neuropathic pain after treatment, Pregabalin improved pain scores and quality of life compared with placebo [20]. Gabapentinoids have also been found to interact synergistically with opioids through the inhibition of nociception and simultaneous decrease in hyperexcitation [5].…”

Section: Introductionmentioning

confidence: 99%

Opioid therapy vs. multimodal analgesia in head and neck Cancer (OPTIMAL-HN): study protocol for a randomized clinical trial

et al. 2021

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Background Radiation-induced mucositis (RIM) pain confers substantial morbidity for head and neck cancer (HNC) patients undergoing radiotherapy alone (RT) or chemoradiotherapy (CRT), often reducing treatment compliance. However, no standard currently exists for the treatment of RIM, and high dose opioid therapy, with its associated side effects and increased risk for chronic opioid use, remains the cornerstone of HNC pain management. The goal of this randomized clinical trial is to compare multimodal analgesia using analgesic medications with different mechanisms of action, to the institutional standard of opioid analgesia alone, in order to ascertain the optimal analgesic regimen for the management of RIM pain in HNC patients. Methods In this open-label, single-institution, non-inferiority, randomized clinical trial, sixty-two patients with mucosal head and neck malignancies treated with curative-intent radiation will be randomized in a 1:1 ratio, stratified by RT or CRT, between Arm 1: opioid analgesia alone as per the institutional standard, or Arm 2: multimodal analgesia using Pregabalin, Acetaminophen, and Naproxen, in addition to opioids, if required. The primary endpoint is the average 11-Numeric Rating Scale (11-NRS) score for pain during the last week of radiation treatment. Secondary endpoints include: average weekly opioid use, duration of opioid requirement, average daily 11-NRS score for pain, average weekly opioids dispensed, quality of life, hospitalizations for analgesic medication-induced complications, time to feeding tube insertion, weight loss, toxicity, treatment interruptions, and death within 3 months of completing RT treatment. Patients are eligible once analgesia is required for moderate 4/10 pain. Discussion This study will assess the efficacy and safety of multimodal analgesia and its impact on opioid requirements, clinical outcomes, and quality of life, as a potential new standard treatment for RIM pain in HNC patients undergoing definitive RT or CRT. Trial registration ClinicalTrials.gov Identifier: NCT04221165. Date of registration: January 9, 2020. Appendix 2 reports the World Health Organization trial registration dataset.

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“…In accordance with the WHO pain ladder, strong opioids are the mainstay of analgesic therapy in treating moderate to severe cancer-related pain, including HNC pain [14][15][16]. Previous studies have described that adequate pain relief for patients with HNC who suffer from RT-related oral mucositis is difficult to achieve [13,[17][18][19][20][21]. For this group of patients, local guidelines at Pain and Rehabilitation Centre (PRC), University Hospital, Linköping, Sweden, are based on the WHO ladder, i.e., acetaminophen, non-steroid anti-inflammatory drugs (NSAID), and opioid analgesics [15].…”

Section: Introductionmentioning

confidence: 99%

“…As a complement all patients with HNC undergo weekly oral care checks by the hospital dentist and use daily mouthwash with lidocaine hydrochloride and mycostatin. When the pain mechanism is considered to be neuropathic, adjuvant analgesia can be provided with gabapentinoids such as pregabalin [21]. Attention is given to side effects of opioid therapy such as dry mouth, constipation, nausea, and decreased alertness [19,22].…”

Section: Introductionmentioning

confidence: 99%

Pain management in patients undergoing radiation therapy for head and neck cancer – a descriptive study

Schaller

Peterson

Bäckryd

2020

Scandinavian Journal of Pain

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ObjectivesPatients with head and neck cancer (HNC) experience serious pain related to tumour, surgery, chemotherapy, and radiotherapy treatment (RT). Oral mucositis, a painful complication of RT, may require opioid analgesics to control pain.This longitudinal study, during RT but also four weeks post-RT, examines the relationships between oral mucositis, pain, and opioid doses in in HNC patients. The aim was to evaluate the clinical effectiveness of an opioid treatment strategy.MethodsSixty-three patients with HNC undergoing radiotherapy answered self-reported questionnaires on pain intensity on a 0–10 numerical rating scale (NRS) three times a week. Oral mucositis signs were evaluated using the WHO mucositis index score, ranging from 0 (normal) to 4 (severe), and pharmacological treatment with opioids was registered prospectively once a week. All data were related to given radiation dose, and all outcome measures at each time point therefore relate to the same radiation dose (i.e., not to when the patient was included in the study).ResultsOpioids were used by 78% of the patients. Most of the patients experienced only mild pain (NRS 0–4), although the majority developed mucositis grade 2–4 according to WHO mucositis index. Function-related pain intensity and opioid doses were highest during the sixth week of RT, with 3.67 (0–9) in NRS and 84 (0–430) mg oral morphine equivalents per day (median, range). At that same time point, significant positive correlations were found between the grade of mucositis and pain intensities. Patients with mucositis grade 2–4 were investigated further; in this subgroup, we found that opioid doses did not differ between patients with mild pain and patients with moderate to severe pain. Our multivariate data analysis defined a cluster of patients characterized by the presence of mucositis, cancer site in pharynx, concomitant chemotherapy, and the absence of surgery.ConclusionsIn HNC patients who were followed closely by pain care personnel during and after RT, pain was often satisfactorily alleviated with a structured use of opioids, including stepwise increases of fentanyl patches and oral morphine as needed. However, some patients with oral mucositis grade 2–4 experienced severe pain. Strong opioids, i.e. the third step of the WHO pain ladder, remain the mainstay of analgesic therapy in treating moderate to severe cancer-related pain, including patients with HNC. This real-life study indicates that RT-related pain is not a fatality. A proactive stance, monitoring these patients closely and regularly, is probably crucial in order to achieve good treatment results. Further studies are needed to develop better pain treatment strategies for those patients who develop severe oral mucositis-related pain despite intensive opioid treatment.

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Effect of Pregabalin on Radiotherapy-Related Neuropathic Pain in Patients With Head and Neck Cancer: A Randomized Controlled Trial

Cited by 36 publications

References 37 publications

Pharmacotherapeutic Options for Managing Neuropathic Pain: A Systematic Review and Meta-Analysis

Pharmacotherapeutic Options for Managing Neuropathic Pain: A Systematic Review and Meta-Analysis

Opioid therapy vs. multimodal analgesia in head and neck Cancer (OPTIMAL-HN): study protocol for a randomized clinical trial

Pain management in patients undergoing radiation therapy for head and neck cancer – a descriptive study

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