scholarly journals Percutaneous Cordotomy for Pain Palliation in Advanced Cancer: A Randomized Clinical Trial Study Protocol

Neurosurgery ◽  
2020 ◽  
Vol 87 (2) ◽  
pp. 394-402 ◽  
Author(s):  
Ashwin Viswanathan ◽  
Aditya Vedantam ◽  
Loretta A Williams ◽  
Dhanalakshmi Koyyalagunta ◽  
Salahadin Abdi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cancer Pain ◽  
Pain Intensity ◽  
Randomized Clinical Trial ◽  
Advanced Cancer ◽  
Standard Of Care ◽  
Controlled Clinical Trial ◽  
Level Of Evidence ◽  
Double Blind ◽  
Definitive Evidence

Abstract BACKGROUND Cancer pain, one of the most common symptoms for patients with advanced cancer, is often refractory to maximal medical therapy. A controlled clinical trial is needed to provide definitive evidence to support the use of ablative procedures such as cordotomy for patients with medically refractory cancer pain. OBJECTIVE To assess the efficacy of cordotomy for patients with unilateral advanced cancer pain using a controlled clinical trial study design. The secondary objectives are to define the patient experience of cordotomy for medically refractory cancer pain as well as to determine the utility of magnetic resonance imaging as a non-invasive biomarker for successful cordotomy. METHODS We will undertake a single-institution, double-blind, sham-controlled clinical trial of cordotomy in patients with refractory cancer pain. Patients in the cordotomy arm will undergo a percutaneous computed tomography-guided cordotomy at C1-C2, while patients in the control arm will undergo a similar procedure where the needle will not penetrate the thecal sac. The primary endpoint will be the reduction in pain intensity, as measured by the Edmonton Symptoms Assessment Scale. EXPECTED OUTCOMES We expect that patients randomized to cordotomy will have a significantly greater reduction in pain intensity than those patients randomized to the control surgical intervention. DISCUSSION This randomized clinical trial comparing cordotomy with a control intervention will provide the level of evidence necessary to determine whether cordotomy should be the standard of care intervention for patients with advanced cancer pain.

Randomized Clinical Trial of the Effectiveness of a Self-Care Intervention to Improve Cancer Pain Management

2004 ◽  
Vol 22 (9) ◽  
pp. 1713-1720 ◽  
Author(s):  
Christine Miaskowski ◽  
Marylin Dodd ◽  
Claudia West ◽  
Karen Schumacher ◽  
Steven M. Paul ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pain Management ◽  
Cancer Pain ◽  
Pain Intensity ◽  
Randomized Clinical Trial ◽  
Standard Care ◽  
Psychoeducational Intervention ◽  
Care Group ◽  
Cancer Pain Management ◽  
Standard Care Group

Purpose This randomized clinical trial tested the effectiveness of the PRO-SELF Pain Control Program compared with standard care in decreasing pain intensity scores, increasing appropriate analgesic prescriptions, and increasing analgesic intake in oncology outpatients with pain from bone metastasis. Patients and Methods Patients were randomly assigned to the PRO-SELF intervention (n = 93) or standard care (n = 81). Patients in the standard care arm were seen by a research nurse three times and were called three times by phone between the home visits. PRO-SELF group patients were seen by specially trained intervention nurses and received a psychoeducational intervention, were taught how to use a pillbox, and were given written instructions on how to communicate with their physician about unrelieved pain and the need for changes in their analgesic prescriptions. Patients were coached during two follow-up home visits and three phone calls on how to improve their cancer pain management. Results Pain intensity scores decreased significantly from baseline (all P < .0001) in the PRO-SELF group (ie, least pain, 28.4%; average pain, 32.5%; and worst pain, 27.0%) compared with the standard care group (ie, least increased by 14.6%, average increased by 1.9%, and worst decreased by 1.2%). The percentage of patients in the PRO-SELF group with the most appropriate type of analgesic prescription increased significantly from 28.3% to 37.0% (P = .008) compared with a change from 29.6% to 32.5% in the standard care group. Conclusion The use of a psychoeducational intervention that incorporates nurse coaching within the framework of self-care can improve the management of cancer pain.

Megestrol acetate for anorexia in patients with far-advanced cancer: a double-blind controlled clinical trial

1998 ◽  
Vol 34 (11) ◽  
pp. 1705-1709 ◽  
Author(s):  
F De Conno ◽  
C Martini ◽  
E Zecca ◽  
A Balzarini ◽  
P Venturino ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Advanced Cancer ◽  
Megestrol Acetate ◽  
Controlled Clinical Trial ◽  
Double Blind

Efficacy of gabapentin mouthwash in managing oral mucositis pain in patients undergoing chemotherapy: a prospective, randomised, double-blind, controlled clinical trial

2020 ◽  
Vol 65 (1) ◽  
pp. 12-18
Author(s):  
Shahram Ala ◽  
Neda Zamani ◽  
Jafar Akbari ◽  
Ebrahim Salehifar ◽  
Ghasem Janbabai ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pain Intensity ◽  
Oral Mucositis ◽  
Controlled Trial ◽  
Sufficient Evidence ◽  
Controlled Clinical Trial ◽  
Significant Activity ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference

Background and aims Gabapentin has been used for the management of radiotherapy and chemotherapy induced stomatitis in a number of studies. Due to lack of sufficient evidence, the present study was designed to evaluate the efficacy of gabapentin mouthwash in oral mucositis associated pain in patients undergoing cancer chemotherapy. Methods and results This study was a prospective, randomised, double-blind, placebo-controlled trial. The patients were randomly divided into two groups receiving either the gabapentin or placebo mouthwash. Patients were advised to rinse their mouth with 7 ml of solution for 30 s three times a day and were visited 10 days after initiation of the trial. The intensity of pain and severity of oral mucositis were assessed. Thirty-one patients received gabapentin mouthwash while 27 patients received placebo. Both gabapentin and placebo mouthwashes had decreased the pain intensity almost equally and did not show a significant difference between the two groups (P = 0.73). Also both gabapentin and placebo had reduced and improved swallowing, inflammation and erythema. But there was no noticeable difference between groups (P > 0.05). Conclusions These findings indicate that gabapentin mouthwash did not show a significant activity as a pain relieving agent in chemotherapy induced oral mucositis associated pain.

Ondansetron Augmentation for Treatment-Resistant Obsessive-Compulsive Disorder: A Randomized Placebo-Controlled Clinical Trial

2020 ◽  
Vol 22 (5) ◽  
Author(s):  
Zahra Sepehrmanesh ◽  
Mehdi Adel ◽  
Afshin Ahmadvand ◽  
Mojtaba Sehat
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Obsessive Compulsive Disorder ◽  
Selective Serotonin Reuptake Inhibitors ◽  
Controlled Clinical Trial ◽  
Obsessive Compulsive ◽  
Double Blind ◽  
Compulsive Disorder ◽  
First Line Therapy ◽  
Significant Difference

Background: Serotonin and dopamine are involved in the development of obsessive-compulsive disorder (OCD). Approximately 40% of OCD patients do not respond to the first-line therapy of treatment using selective serotonin reuptake inhibitors. Reportedly, the response to the treatment is increased by enhancing dopamine blockers. Objectives: The purpose of this study was to evaluate the efficacy and immunogenicity of ondansetron as a booster in the treatment of OCD patients. Methods: The present double-blind, randomized clinical trial (RCT) was conducted on 40 patients (16 males and 24 females) aged 18 to 60 years who met the DSM-V-TR-based OCD diagnostic criteria and had a minimum score of 16 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). The patients were randomized to receive standard treatment and ondansetron (8 mg/day) or placebo for 12 weeks. They were examined using Y-BOCS and side-effect checklist at baseline, fourth, eighth, and twelfth weeks. Results: The patients in both groups were homogeneous and comparable in terms of age, marital sex status, type of obsession, anxiety, depression, age at the onset of disease, and the duration of disease. The Y-BOCS scores in the intervention and placebo groups were 27.15 ± 3.94 vs. 26.15 ± 4.94 at baseline, 25.40 ± 3.75 vs. 25.00 ± 4.79 in the fourth week, 20.85 ± 3.69 vs. 24.05 ± 4.97 (P = 0.026) in the eighth week, and 17.95 ± 3.43 vs. 21.65 ± 4.85 (P = 0.008) in the twelfth week, respectively. Significant changes occurred between the two groups at weeks 8 and 12; the difference between the two groups was significant (P = 0.015), whereas no significant difference was observed between the two groups before week 8. Conclusions: This 12-week, double-blind, and randomized clinical trial showed that ondansetron was a booster agent with a significant effect on patients with moderate to severe OCD. This study also showed that ondansetron is generally well tolerated by OCD patients. The response to the treatment also increased from the eighth week of treatment onwards. The severity of the disease was decreased at the end of the ondansetron intervention. The adjunct ondansetron treatment was recommended for OCD patients

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