Faculty Opinions recommendation of A phase III randomized, placebo-controlled study of topical amitriptyline and ketamine for chemotherapy-induced peripheral neuropathy (CIPN): a University of Rochester CCOP study of 462 cancer survivors.

2016 ◽  
Author(s):  
Miriam Freimer
Keyword(s):  
Peripheral Neuropathy ◽  
Cancer Survivors ◽  
Phase Iii ◽  
Controlled Study

scholarly journals A phase III randomized, placebo-controlled study of topical amitriptyline and ketamine for chemotherapy-induced peripheral neuropathy (CIPN): a University of Rochester CCOP study of 462 cancer survivors

2014 ◽  
Vol 22 (7) ◽  
pp. 1807-1814 ◽  
Author(s):  
Jennifer S. Gewandter ◽  
Supriya G. Mohile ◽  
Charles E. Heckler ◽  
Julie L. Ryan ◽  
Jeffrey J. Kirshner ◽  
...  
Keyword(s):  
Peripheral Neuropathy ◽  
Cancer Survivors ◽  
Phase Iii ◽  
Controlled Study

The use of vitamin E for prevention of chemotherapy-induced peripheral neuropathy: A phase III double-blind, placebo controlled study—N05C31

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9532-9532
Author(s):  
L. A. Kottschade ◽  
J. A. Sloan ◽  
M. A. Mazurczak ◽  
D. B. Johnson ◽  
B. Murphy ◽  
...  
Keyword(s):  
Vitamin E ◽  
Peripheral Neuropathy ◽  
Sensory Neuropathy ◽  
Cytotoxic Agents ◽  
Phase Iii ◽  
Controlled Study ◽  
Patient Questionnaire ◽  
Double Blind ◽  
Curative Intent ◽  
Double Blind Placebo

9532 Background: Chemotherapy induced peripheral neuropathy (CIPN) continues to be a substantial problem for many cancer patients (pts). Pursuant to promising appearing pilot data, the current study evaluated the use of vitamin E for the prevention of CIPN. Methods: A phase III, randomized, double-blind, placebo controlled study was conducted in pts undergoing therapy with neurotoxic chemotherapy, utilizing twice daily dosing of vitamin E (400mg)/placebo. The primary endpoint was the incidence of grade 2+ sensory neuropathy (SN) toxicity (CTCAE v 3.0) in each treatment arm, analyzed by Chi-square testing. Major eligibility criteria included: planned curative intent adjuvant chemotherapy with neurotoxic chemotherapy, ≥ 18 years of age, ECOG PS of ≤2, no existing peripheral neuropathy or coronary artery disease, no prior treatment with neurotoxic chemotherapy, and no concurrent treatment with neuropathic or opioid pain medication. Planned sample size was 100 patients per arm, to provide 80% power to detect a difference in incidence of grade 2+ SN toxicity from 25% in the placebo group to 10% in the vitamin E group. Results: Two-hundred seven pts were enrolled between 12/01/2006 and 12/14/2007. Cytotoxic agents included taxanes (109), cisplatin (8), carboplatin (2), oxaliplatin (50) or combination (20). Eleven pts canceled prior to starting treatment and there were 7 ineligible pts on study. Thus there were 189 evaluable pts included in the current analysis. In this analysis, there was no difference in the incidence of grade 2+ SN between the 2 arms (vitamin E- 34% [95% CI- 25.0–44.8%] placebo- 29% [20.1–39.4%]; P=0.43). There, likewise, were no significant differences between treatment arms for time to onset of neuropathy (P= 0.72), for chemotherapy dose reductions due to neuropathy (P= 0.21) or patient questionnaire reported neuropathy symptoms. The treatment was well tolerated overall. Conclusions: Vitamin E did not appear to reduce the incidence of sensory neuropathy in the studied group of patients receiving neurotoxic chemotherapy but it appeared to be well tolerated. No significant financial relationships to disclose.

scholarly journals Yoga for Chemotherapy-Induced Peripheral Neuropathy and Fall Risk: A Randomized Controlled Trial

2020 ◽  
Vol 4 (6) ◽  
Author(s):  
Ting Bao ◽  
Iris Zhi ◽  
Raymond Baser ◽  
Madeline Hooper ◽  
Connie Chen ◽  
...  
Keyword(s):  
Peripheral Neuropathy ◽  
Cancer Survivors ◽  
Usual Care ◽  
Gynecological Cancer ◽  
Controlled Study ◽  
Gynecologic Oncology Group ◽  
Randomized Controlled ◽  
Functional Reach ◽  
Risk Of Falls ◽  
Gynecological Cancer Survivors

Abstract Background Chemotherapy-induced peripheral neuropathy (CIPN) is a common, debilitating side effect that worsens quality of life and increases the risk of falls in cancer survivors. Evidence of yoga’s safety and efficacy in treating CIPN is lacking. Methods In a randomized controlled study, we assigned breast and gynecological cancer survivors with persistent moderate-to-severe CIPN pain, numbness, or tingling with a score of 4 or greater (0-10 numeric rating scale [NRS]) for at least 3 months after chemotherapy to 8 weeks of usual care or yoga focused on breathwork and musculoskeletal conditioning. Primary endpoint was treatment arm differences for NRS, and secondary endpoints were Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity subscale (FACT/GOG-Ntx), and Functional Reach Test after week 8. We tested treatment arm differences for each outcome measure using linear mixed models with treatment-by-time interactions. All statistical tests were two-sided. Results We randomly assigned 41 participants into yoga (n = 21) or usual care (n = 20). At week 8, mean NRS pain decreased by 1.95 points (95% confidence interval [CI] = -3.20 to -0.70) in yoga vs 0.65 (95% CI = -1.81 to 0.51) in usual care (P = .14). FACT/GOG-Ntx improved by 4.25 (95% CI = 2.29 to 6.20) in yoga vs 1.36 (95% CI = -0.47 to 3.19) in usual care (P = .035). Functional reach, an objective functional measure predicting the risk of falls, improved by 7.14 cm (95% CI = 3.68 to 10.59) in yoga and decreased by 1.65 cm (95% CI = -5.00 to 1.72) in usual care (P = .001). Four grade 1 adverse events were observed in the yoga arm. Conclusion Among breast and gynecological cancer survivors with moderate-to-severe CIPN, yoga was safe and showed promising efficacy in improving CIPN symptoms.

The efficacy of lamotrigine in the management of chemotherapy-induced peripheral neuropathy: A phase III randomized, double blind, placebo-controlled NCCTG trial, N01C3

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 8530-8530 ◽  
Author(s):  
S. I. Renno ◽  
R. D. Rao ◽  
J. Sloan ◽  
G. Wong ◽  
D. Johnson ◽  
...  
Keyword(s):  
Peripheral Neuropathy ◽  
Rating Scale ◽  
Eastern Cooperative Oncology Group ◽  
Sensory Neuropathy ◽  
Phase Iii ◽  
Controlled Study ◽  
Type I ◽  
Double Blind ◽  
Point Change ◽  
Chemotherapy Drugs

8530 Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common dose limiting complication of chemotherapy. Lamotrigine (an anti-convulsant drug) appears to have some benefit when used to treat pain from neuropathy due to various etiologies. Based on these data, we conducted a phase III randomized placebo controlled study to determine the efficacy of lamotrigine in treating symptoms from CIPN. Methods: Patients with CIPN for 1 month or more were randomly assigned to lamotrigine (target dose 300 mg/day, increased by 50 mg/2 weeks) or placebo for 10 weeks. The co-primary endpoints were differences in average CIPN symptoms assessed by pro-rated area under the curve (AUC) of a numerical pain rating scale (NRS) and the Eastern Cooperative Oncology Group sensory neuropathy (ESN) scale. Accrual of 60 patients per group provided t-tests with 80% power to detect a difference of 0.57 standard deviation for each co-primary endpoint (moderate effect size) with a type I error of 0.025. Results: 131patients were enrolled, with complete data available for analysis in 93 (72%). Analyses were limited to this cohort but will be updated. Chemotherapy drugs considered to be causative of the CIPN were vinca alkaloids (30%), taxanes (25%), platinum-agents (7%), combinations (34%), and others (3%). Patients were equally matched with regards to baseline characteristics. Patients who enrolled had severe symptoms, with a baseline median ESN at enrollment of 3 (out of 3) in both groups. Toxicities were similar in both groups, however, more patients discontinued lamotrigine due to toxicities/refusals than those on placebo (32% vs 13% resp; p=0.04) and were therefore less likely to complete the 10 weeks therapy (60% vs. 78% resp, p=0.08). Average AUC of NRS score for patients on lamotrigine and placebo was 30.5 and 33.7 resp (p=0.48). The corresponding average AUC of the ESN scores were 12.4 and 14.5 (p=0.23). The proportions of patients with a 10 point (of 100) improvement in worst pain score (39% vs 36%) and a 1 point change in ESN (25% vs 27%) were similar between the lamotrigine and placebo arms, resp. Conclusions: These results suggest that lamotrigine is not effective for managing pain and symptoms due to CIPN. No significant financial relationships to disclose.

Oral Alpha Lipoic Acid Treatment for Symptomatic Diabetic Peripheral Neuropathy: A Randomized Double-Blinded Placebo-Controlled Study

2020 ◽  
Vol 20 (9) ◽  
pp. 1531-1534 ◽  
Author(s):  
Mamdouh R. El-Nahas ◽  
Ghada Elkannishy ◽  
Hala Abdelhafez ◽  
Enas T. Elkhamisy ◽  
Amr A. El-Sehrawy
Keyword(s):  
Peripheral Neuropathy ◽  
Lipoic Acid ◽  
Diabetic Peripheral Neuropathy ◽  
Study Groups ◽  
Controlled Study ◽  
Alpha Lipoic Acid ◽  
Disability Score ◽  
Perception Threshold ◽  
Outcome Parameters ◽  
Double Blinded

Background: Alpha-lipoic acid (ALA) was used in the treatment of diabetic peripheral neuropathy (DPN) using different routes, doses and treatment durations. The aim of this work is to assess the efficacy of oral 600mg ALA twice daily over 6 months in the treatment of patients with DPN. Methods: This is a prospective, single-center, double-blinded, placebo-controlled study conducted at the outpatient clinic of Mansoura Specialized Hospital, Mansoura University. A total of 200 patients with DPN were randomly assigned to add on treatment with either oral 600mg twice daily ALA (n=100) or placebo (n=100) for 6 months. Treatment outcome was assessed using vibration perception threshold (VPT), neurological symptom score (NSS), neurological disability score (NDS), and visual analog scale (VAS) for pain at baseline and at each visit (1, 3 and 6 months) after the start of treatment. Results: Comparison between the study groups regarding the baseline data revealed no statistically significant differences. with respect to the outcome parameters, no significant differences were found between the studied groups at baseline. However, in subsequent visits, ALA-treated patients had significantly better results regarding almost all the outcome parameters (NSS, NDS, VAS, VPT). Mild nausea was reported in 6 patients. None of the studied patients discontinued treatment. Conclusions: Oral 600mg ALA twice-daily treatment for DPN over 6 months is effective, safe and tolerable.

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