scholarly journals A Prospective, Multicenter, Open-Label Study of The Clinical Efficacy of Tapentadol Extended-Release in The Treatment of Cancer-Related Pain and Improvement of Quality of Life in Opioid-Naïve or Opioid-Resistant Patients

Author(s):  
Jiyoon Jung ◽  
Hong Jae Chon ◽  
YoungJin Choi ◽  
SangEun Yeon ◽  
SeokYoung Choi ◽  
...  

Abstract Purpose: This study was to investigate the clinical efficacy of tapentadol extended-release (ER) on pain control and the quality of life of patients with moderate to severe chronic cancer pain in clinical practice in Korea.Methods: In this prospective, open-label, multicenter trial, patients with sustained cancer pain as well as chronic pain, using or not using other analgesics were enrolled. Thirteen centers recorded a total of 752 patients, during the 6-month observation period, based on the tapentadol ER dose and tolerability, prior and concomitant analgesic treatment, pain intensity, type of pain, adverse effects, and clinical global impression change (CGI-C). A total of 752 patients were screened, 688 were enrolled, and 650 completed the study for efficacy and adverse drug reactions; among them 349 were cancer patients.Results: In total, 752 patients were screened, 688 were enrolled and 650 were completed the study for efficacy and adverse drug reactions, 349 of whom were cancer patients. Tapentadol ER significantly reduced the mean pain intensity including neuropathic pain during the observation period by 2.9 points (from a mean 7±0.87 to 4.1±2.02). Furthermore, the quality of life was observed to be significantly improved based on an objective observation, such as the CGI-C.Conclusion: This study showed that tapentadol ER was effective in patients with moderate to severe cancer pain and was also effective in neuropathic pain, and therefore it significantly improved the patients’ quality of life.

2002 ◽  
Vol 88 (3) ◽  
pp. 239-242 ◽  
Author(s):  
Sebastiano Mercadante ◽  
Edoardo Arcuri ◽  
Walter Tirelli ◽  
Patrizia Villari ◽  
Alessandra Casuccio

Aims and Background Amitriptyline is the most common analgesic adjuvant used in cancer patients with neuropathic pain, even though no specific studies have demonstrated a benefit. A randomized placebo-controlled, double-blind crossover study was designed to evidence the effects of amitriptyline in patients with neuropathic cancer pain. Methods Sixteen advanced cancer patients with neuropathic pain on systemic morphine therapy, no longer receiving oncologic treatment, presenting moderate pain (about 4 or more, but less than 7, on a numerical scale of 0-10) in the last week, and given a stable morphine dose in the last 2 days were admitted to the study. During the first week of study, patients were administered 25 mg of amitriptyline or equivalent drops of placebo at night for 3 days and 50 mg for the following 4 days. Doses for patients aged more than 65 years were 15 mg (first 3 days) and 30 mg (3 days after). After a week, a crossover took place for the second week, with the other treatment at an inverse sequence. Opioid consumption, pain intensity, symptoms and adverse effects, mood, sleep, patient's preference, quality of life before starting the study, the first week after and the second week after were recorded. Results No significant benefits in analgesia were found in the global pain intensity of the previous week of treatment, the least pain intensity or the pain evaluated just after a week of treatment, at the moment of the visit, when amitriptyline was compared with placebo. A significant difference was evidenced for the worst pain (P < 0.035). No differences in opioid doses during the period of study were found. Drowsiness, confusion and dry mouth were significantly more intense with amitriptyline than with placebo (P < 0.036, 0.003, and 0.034, respectively). There were no substantial differences between the two treatments in Spitzer's quality of life score and for each item. No differences in patients' preference for the two treatment periods were found. The analgesic effects of amitriptyline were slight and associated with adverse effects. Conclusions In light of the results obtained in the study, the extensive use of the drug for cancer pain should be questioned.


2015 ◽  
Vol 20 (6) ◽  
pp. 293-299 ◽  
Author(s):  
Eun-Kee Song ◽  
Hyunjeong Shim ◽  
Hye-Suk Han ◽  
DerSheng Sun ◽  
Soon-Il Lee ◽  
...  

BACKGROUND: Osmotic release oral system (OROS®) hydromorphone is a potent, long-acting opioid analgesic, effective and safe for controlling cancer pain in patients who have received other strong opioids. To date, few studies have examined the efficacy of hydromorphone for pain relief in opioid-naive cancer patients.OBJECTIVES: A prospective, open-label, multicentre trial was conducted to determine the efficacy and tolerability of OROS hydromorphone as a single and front-line opioid therapy for patients experiencing moderate to severe cancer pain.METHODS: OROS hydromorphone was administered to patients who had not previously received strong, long-acting opioids. The baseline evaluation (visit 1) was followed by two evaluations (visits 2 and 3) performed two and 14 weeks later, respectively. The starting dose of OROS hydromorphone was 4 mg/day and was increased every two days when pain control was insufficient. Immediate-release hydromorphone was the only accepted alternative strong opioid for relief of breakthrough pain. The efficacy, safety and tolerability of OROS hydromorphone, including the effects on quality of life, and patients’ and investigators’ global impressions on pain relief were evaluated. The primary end point was pain intensity difference (PID) at visit 2 relative to visit 1 (expressed as %PID).RESULTS: A total of 107 patients were enrolled in the present study. An improvement in pain intensity of >50% (≥50% PID) was observed in 51.0% of the full analysis set and 58.6% of the per-protocol set. The mean pain score, measured using a numerical rating scale, was significantly reduced after two weeks of treatment, and most adverse events were manageable. Quality of life also improved, and >70% of patients and investigators were satisfied with the treatment.CONCLUSIONS: OROS hydromorphone provided effective pain relief and improved quality of life in opioid-naive cancer patients. As a single and front-line treatment, OROS hydromorphone delivered rapid pain control.


2021 ◽  
Author(s):  
Jui-hung Tsai ◽  
I-Ting Liu ◽  
Pei-Fang Su ◽  
Ying-Tzu Huang ◽  
Ge-Lin Chiu ◽  
...  

Abstract PurposeLimited efficacy has been observed when using morphine to treat neuropathic pain. Lidocaine patches reduce neuropathic pain in post-herpetic neuralgia, but their benefits for cancer-related neuropathic pain remain unclear. This study aimed to demonstrate a useful treatment for cancer-related neuropathic pain. The primary endpoint was pain intensity evaluated by the visual analog scale (VAS). The secondary endpoints were the pain relief score and the quality of analgesic treatment. MethodsWe assessed the efficacy and safety of lidocaine patches in patients experiencing neuropathic cancer pain. Terminal cancer patients with opioid treatment resistance participated in the 3-day study. ResultsThe results showed a statistically significant difference in the median VAS over three days (Kruskal-Wallis test, P<0.0001). The median VAS pain intensity from Day 1 to Day 3 was 4.0 with 95% C.I. (3.3, 5.0), 3.0 (2.5, 3.5) and 2.5 (2.0, 3.0), respectively. The difference between the median VAS pain intensities of any two days was statistically significant (Wilcoxon signed-rank test, P < 0.0001). There was no statistically significant difference in the pain relief score or the quality of analgesic treatment. ConclusionIn this study, the 5% lidocaine transdermal patch reduced the VAS pain intensity in neuropathic cancer patients with morphine resistance. The transdermal patch is generally useful and well-tolerated.


Neurosurgery ◽  
2017 ◽  
Vol 83 (1) ◽  
pp. 146-153 ◽  
Author(s):  
Pierre-Yves Borius ◽  
Stéphanie Ranque Garnier ◽  
Karine Baumstarck ◽  
Frédéric Castinetti ◽  
Anne Donnet ◽  
...  

Abstract BACKGROUND Hypophysectomy performed by craniotomy or percutaneous techniques leads to complete pain relief in more than 70% to 80% of cases for opioid refractory cancer pain. Radiosurgery could be an interesting alternative approach to reduce complications. OBJECTIVE To assess the analgesic efficacy compared with standard of care is the primary goal. The secondary objectives are to assess ophthalmic and endocrine tolerance, drug consumption, quality of life, and mechanisms of analgesic action. METHODS The trial is multicenter, randomized, prospective, and open-label with 2 parallel groups. This concerns patients in palliative care suffering from nociceptive or mixed cancer pain, refractory to standard opioid therapy. Participants will be randomly assigned to the control group receiving standards of care for pain according to recommendations, or to the experimental group receiving a pituitary GammaKnife (Elekta, Stockholm, Sweden) radiosurgery (160 Gy delivered in pituitary gland) associated with standards of care. Evaluation assessments will be taken at baseline, day0, day4, day7, day14, day28, day45, month3, and month6. EXPECTED OUTCOMES We could expect pain improvement in 70% to 90% of cases at day4. In addition we will assess the safety of pituitary radiosurgery in a vulnerable population. The secondary endpoints could show decay of opioid consumption, good patient satisfaction, and improvement of the quality of life. DISCUSSION The design of this study is potentially the most appropriate to demonstrate the efficacy and safety of radiosurgery for this new indication. New recommendations could be obtained in order to improve pain relief and quality of life.


2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Yinxia Wang ◽  
Ligang Xing

Radiotherapy is commonly used to treat cancer patients. Besides the curable effect, radiotherapy also could relieve the pain of cancer patients. However, cancer pain is gradually alleviated about two weeks after radiotherapy. In addition, cancer patients who receive radiotherapy may also suffer from pain flare or radiotherapy-induced side effects such as radiation esophagitis, enteritis, and mucositis. Pain control is reported to be inadequate during the whole course of radiotherapy (before, during, and after radiotherapy), and quality of life is seriously affected. Hence, radiotherapy is suggested to be combined with analgesic drugs in clinical guidelines. Previous studies have shown that radiotherapy combined with oxycodone hydrochloride can effectively alleviate cancer pain. In this review, we firstly presented the necessity of analgesia during the whole course of radiotherapy. We also sketched the role of oxycodone hydrochloride in radiotherapy of bone metastases and radiotherapy-induced oral mucositis. Finally, we concluded that oxycodone hydrochloride shows good efficacy and tolerance and could be used for pain management before, during, and after radiotherapy.


Author(s):  
NURUL QIYAAM ◽  
WIRAWAN ADIKUSUMA ◽  
BAIQ LENY NOPITASARI ◽  
TRI MURTI ANDAYANI ◽  
AULIA AMINI

Objective: Stroke is defined as a sudden loss of brain function due to blockade/rupture of the brain’s blood vessels. Data collected by the Indonesian Stroke Foundation show that Indonesia ranks first in Asia as the country with the highest number of stroke sufferers. The purpose of this study was to determine the effectiveness of the use of gabapentin to reduce pain intensity and improve the quality of life of post-stroke neuropathic pain in NTB Province hospital patients. Methods: This study was carried out in the period of June–July 2018. The targeted population was all post-stroke neuropathic patients who received gabapentin therapy in NTB provincial hospital. Affordable populations are post-stroke neuropathic pain patients who seek outpatient treatment at NTB provincial hospital that meets the inclusion and exclusion criteria. The results of the data will be analyzed using paired sample t-test. Obtained 15 patients were willing to participate in this study. Results: The results of the study using questionnaire EQ-5D-3L after using gabapentin for 2 weeks. Patients experienced an improvement in the quality of life in each dimension items, namely the ability to walk/move from 6.7%, no problem to 60%, no self-care, 26.7% no problem to be 80% without problems, usual activities carried out from 13.3% had no problems to 46.7% had no problems, feeling of pain/discomfort from 60% having moderate problems to 60% had no problems, and anxiety/depression of 60% had no problem being 100% has no problem. While the measurement of the quality of life using the EQ-VAS questionnaire, there was a significant improvement in the quality of life between before and after using gabapentin at 32.66. Conclusion: The use of gabapentin has effectiveness on reduction of pain intensity and the quality of life of post-stroke neuropathic patients in regional general hospital, West Nusa Tenggara Province year 2018.


1997 ◽  
Vol 15 (3) ◽  
pp. 1218-1234 ◽  
Author(s):  
J Glaspy ◽  
R Bukowski ◽  
D Steinberg ◽  
C Taylor ◽  
S Tchekmedyian ◽  
...  

PURPOSE To study the impact of Procrit (epoetin alfa; Amgen Inc, Thousand Oaks, CA) on quality of life, transfusion requirements, and hemoglobin in anemic cancer patients receiving chemotherapy. PATIENTS AND METHODS More than 500 community-based oncologists enrolled 2,342 patients with malignancies undergoing cytotoxic chemotherapy in an open-label study. Patients were treated with epoetin alfa 150 U/kg three times weekly, which could be doubled if the therapuetic response was judged inadequate. Total treatment was up to 4 months. RESULTS Of the 2,342 patients enrolled, data were available for 2,030 patients. Of the 2,030, 1,047 patients completed all 4 months of epoetin alfa therapy. Epoetin alfa was associated with significant increases in mean self-rated scores for energy level, activity level, and overall quality of life; these improvements correlated with the magnitude of the hemoglobin increase and were independent of tumor response. In addition, epoetin alfa was associated with a significant increase in mean hemoglobin and with a significant decrease in the proportion of patients requiring transfusions (baseline to final value, P < .001). Epoetin alfa was well tolerated. CONCLUSION Epoetin alfa is effective in improving the functional status and quality of life in anemic cancer patients receiving chemotherapy, as well as increasing hemoglobin level and decreasing transfusion requirements. Improvement in functional status can be attributed to an increase in hemoglobin level, demonstrating that quality of life in this group of patients can be improved by aggressively treating anemia. Further studies will be required to define the optimal doses and schedules for epoetin alfa.


2007 ◽  
Vol 5 (8) ◽  
pp. 824
Author(s):  
_ _

Pain is one of the most common symptoms associated with cancer and one of the symptoms patients fear most; unrelieved pain denies them comfort and greatly affects their activities, motivation, interactions with family and friends, and overall quality of life. The importance of relieving pain and availability of effective therapies make it imperative that clinicians caring for cancer patients to be adept at assessing and treating cancer pain. The National Comprehensive Cancer Network Adult Cancer Pain Clinical Practice Guidelines in Oncology acknowledge the range of complex decisions faced in caring for these patients. As a result, they provide dosing guidelines for NSAIDs, opioids, and adjuvant analgesics. They also provide specific suggestions for escalating opioid dosage, managing opioid toxicity, and when and how to proceed to other techniques to manage cancer pain. For the most recent version of the guidelines, please visit NCCN.org


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