Dataset Information

Effects of Cryotherapy on Objective and Subjective Symptoms of Paclitaxel-Induced Neuropathy: Prospective Self-Controlled Trial.

ABSTRACT:

Background

Chemotherapy-induced peripheral neuropathy (CIPN) is a dose-limiting and disabling side effect of taxane anticancer agents. We prospectively evaluated the efficacy of cryotherapy for CIPN prevention.

Methods

Breast cancer patients treated weekly with paclitaxel (80?mg/m2 for one hour) wore frozen gloves and socks on the dominant side for 90?minutes, including the entire duration of drug infusion. Symptoms on the treated sides were compared with those on the untreated (nondominant) sides. The primary end point was CIPN incidence assessed by changes in tactile sensitivity from pretreatment baseline in a monofilament test at a cumulative dose of 960?mg/m2. We also assessed thermosensory deficits, subjective symptoms (Patient Neuropathy Questionnaire [PNQ]), manipulative dexterity, and the time to events and hazard ratio by PNQ. All statistical tests were two-sided.

Results

Among the 40 patients, four did not reach the cumulative dose (due to the occurrence of pneumonia, severe fatigue, severe liver dysfunction, and macular edema), leaving 36 patients for analysis. None dropped out due to cold intolerance. The incidence of objective and subjective CIPN signs was clinically and statistically significantly lower on the intervention side than on the control (hand: tactile sensitivity = 27.8% vs 80.6%, odds ratio [OR] = 20.00, 95% confidence interval [CI] = 3.20 to 828.96, P < .001; foot: tacile sensitivity = 25.0% vs 63.9%, OR = infinite, 95% CI?=?3.32 to infinite, P < .001; hand: warm sense = 8.8% vs 32.4%, OR?=?9.00, 95% CI?=?1.25 to 394.48, P = .02; foot: warm sense: 33.4% vs 57.6%, OR?=?5.00, 95% CI?=?1.07 to 46.93, P = .04; hand: PNQ = 2.8% vs 41.7%, OR = infinite, 95% CI?=?3.32 to infinite, P < .001; foot: PNQ = 2.8% vs 36.1%, OR = infinite, 95% CI?=?2.78 to infinite, P < .001; hand: hazard ratio [HR] = 0.13, 95% CI?=?0.05 to 0.34; foot: HR?=?0.13, 95% CI?=?0.04 to 0.38, dexterity mean delay?=?-2.5?seconds, SD?=?12.0?seconds, vs?+?8.6?seconds, SD?=?25.8?seconds, P = .005).

Conclusions

Cryotherapy is useful for preventing both the objective and subjective symptoms of CIPN and resultant dysfunction.

SUBMITTER: Hanai A

PROVIDER: S-EPMC6007752 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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Publications

Effects of Cryotherapy on Objective and Subjective Symptoms of Paclitaxel-Induced Neuropathy: Prospective Self-Controlled Trial.

Hanai Akiko A Ishiguro Hiroshi H Sozu Takashi T Tsuda Moe M Yano Ikuko I Nakagawa Takayuki T Imai Satoshi S Hamabe Yoko Y Toi Masakazu M Arai Hidenori H Tsuboyama Tadao T

Journal of the National Cancer Institute 20180201 2

<h4>Background</h4>Chemotherapy-induced peripheral neuropathy (CIPN) is a dose-limiting and disabling side effect of taxane anticancer agents. We prospectively evaluated the efficacy of cryotherapy for CIPN prevention.<h4>Methods</h4>Breast cancer patients treated weekly with paclitaxel (80 mg/m2 for one hour) wore frozen gloves and socks on the dominant side for 90 minutes, including the entire duration of drug infusion. Symptoms on the treated sides were compared with those on the untreated (n ...[more]

PMID: 29924336

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Project description:Introduction: We conducted a randomized controlled trial evaluating the efficacy and tolerability of cryotherapy in preventing chemotherapy-induced peripheral neuropathy (CIPN) in patients with early breast cancer receiving neo/adjuvant weekly paclitaxel. Methods: Patients were recruited from the National Cancer Centre Singapore and randomized (1:1) to receive either cryotherapy or usual care. Cryotherapy was applied as frozen gloves and socks on all extremities from 15 min before paclitaxel until 15 min post-infusion every cycle. Efficacy was measured by patient-reported outcomes (Patient Neurotoxicity Questionnaire [PNQ] and EORTC QLQ-CIPN20) and electrophysiological assessments. The primary endpoint was PNQ severity at 2 weeks after 12 cycles of weekly paclitaxel. Results: A total of 46 patients were recruited, of which 8 dropped out before paclitaxel treatment, leaving 38 evaluable. There was no significant difference in PNQ severity between cryotherapy and usual care at 2 weeks after paclitaxel treatment (sensory: p = 0.721; motor: p = 1.000). A benefit was observed at 3 months post-paclitaxel based on PNQ (sensory: 14.3 vs. 41.2%, p = 0.078; motor: 0 vs. 29.4%, p = 0.012) and CIPN20 (sensory: β = -3.6, 95%CI = -10.5-3.4, p = 0.308; motor: β = -7.3, 95%CI = -14.6-0, p = 0.051). Additionally, cryotherapy subjects have lower CIPN20 autonomic score (β = -5.84, 95%CI = -11.15 to -0.524, p = 0.031) and higher sympathetic skin response hand amplitudes (β = 0.544, 95%CI = 0.108-0.98, p = 0.014), suggesting possible autonomic benefits from cryotherapy. Temporary interruption with cryotherapy occurred in 80.9% of the subjects due to cold intolerance. Conclusions: There is insufficient evidence that cryotherapy prevents sensory neuropathy which may be due to the high rates of cryotherapy interruption in this study. The autonomic benefits of cryotherapy should be further investigated with appropriate outcome measures. Clinical Trial Registration: ClinicalTrials.gov: NCT03429972.

Project description:BackgroundPost-traumatic trigeminal neuropathy (PTN) can have a substantial effect on patient well-being. However, the relation between the neuropathic symptoms and their effect on psychosocial functioning remains a matter of debate. The purpose of this study was to evaluate the association between objective and subjective assessments of neurosensory function in PTN and predict neurosensory outcome using baseline measurements.MethodsThis prospective observational cohort study included patients diagnosed with PTN at the Department of Oral and Maxillofacial Surgery, University Hospital Leuven, Belgium, between April 2018 and May 2020. Standardized objective and subjective neurosensory examinations were recorded simultaneously on multiple occasions during the follow-up period. Correlation analyses and principal component analysis were conducted, and a prediction model of neurosensory recovery was developed.ResultsQuality of life correlated significantly (P < 0.05) with percentage of affected dermatome (ρ = - 0.35), the presence of brush stroke allodynia (ρ = - 0.24), gain-of-function sensory phenotype (ρ = - 0.41), Medical Research Council Scale (ρ = 0.36), and Sunderland classification (ρ = - 0.21). Quality of life was not significantly correlated (P > 0.05) with directional discrimination, stimulus localization, two-point discrimination, or sensory loss-of-function. The prediction model showed a negative predictive value for neurosensory recovery after 6 months of 87%.ConclusionsWe found a strong correlation of subjective well-being with the presence of brush stroke allodynia, thermal and/or mechanical hyperesthesia, and the size of the neuropathic area. These results suggest that positive symptoms dominate the effect on affect. In patients reporting poor subjective well-being in the absence of positive symptoms or a large neuropathic area, additional attention towards psychosocial triggers might enhance treatment outcome. The prediction model could contribute to establishing realistic expectations about the likelihood of neurosensory recovery but remains to be validated in future studies.

Project description:ObjectivesThe qualitative subjective assessment has been exercised either by self-reflection (self-assessment (SA)) or by an observer (peer assessment (PA)) and is considered to play an important role in students' development. The objectivity of PA and SA by students as well as those by faculty examiners has remained debated. This matters most when it comes to a high-stakes examination. We explored the degree of objectivity in PA, SA, as well as the global rating by examiners being Examiners' Subjective Assessment (ESA) compared with Objective Structured Clinical Examinations (OSCE).DesignProspective cohort study.SettingUndergraduate medical students at Alfaisal University, Riyadh.ParticipantsAll second-year medical students (n=164) of genders, taking a course to learn clinical history taking and general physical examination.Main outcome measuresA Likert scale questionnaire was distributed among the participants during selected clinical skills sessions. Each student was evaluated randomly by peers (PA) as well as by himself/herself (SA). Two OSCEs were conducted where students were assessed by an examiner objectively as well as subjectively (ESA) for a global rating of confidence and well-preparedness. OSCE-1 had fewer topics and stations, whereas OSCE-2 was terminal and full scale.ResultsOSCE-1 (B=0.10) and ESA (B=8.16) predicted OSCE-2 scores. 'No nervousness' in PA (r=0.185, p=0.018) and 'confidence' in SA (r=0.207, p=0.008) correlated with 'confidence' in ESA. In 'well-preparedness', SA correlated with ESA (r=0.234, p=0.003).ConclusionsOSCE-1 and ESA predicted students' performance in the OSCE-2, a high-stakes evaluation, indicating practical 'objectivity' in ESA, whereas SA and PA had minimal predictive role. Certain components of SA and PA correlated with ESA, suggesting partial objectivity given the limited objectiveness of ESA. Such difference in 'qualitative' objectivity probably reflects experience. Thus, subjective assessment can be used with some degree of objectivity for continuous assessment.

Project description:Background: Paclitaxel-induced peripheral neuropathy (PN) is a serious clinical problem with no approved drug for prevention. This study aimed to examine the neuroprotective effect of metformin against paclitaxel-induced PN in breast cancer patients. Methods: Patients with confirmed breast cancer diagnosis who were planned to receive paclitaxel were randomized to receive either metformin or placebo. Both groups received the standard chemotherapy protocol for breast cancer. Patients started metformin/placebo 1 week before paclitaxel initiation and continued study interventions thereafter for nine consecutive weeks. The primary outcome was the incidence of development of grade two or more paclitaxel-induced sensory PN. The PN was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Patients’ quality of life (QoL) was assessed by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACTGOG-Ntx) subscale. Pain severity was measured by the Brief Pain Inventory Short Form (BPI-SF). Serum levels of nerve growth factor (NGF) and neurotensin (NT) were measured at baseline and at the end paclitaxel treatment. Results: A total of 73 patients (36 in the metformin arm and 37 in the control arm) were evaluated. The cumulative incidence of development of grade two or more PN was significantly lower in the metformin arm (14 (38.9%) than the control arm (28 (75.7%); p = 0.001). At the end of paclitaxel treatment, patients’ QoL was significantly better in the metformin arm [median (IQR) FACTGOG-Ntx subscale of (24.0 (20.5–26.5)] compared to the control arm (21.0 (18.0–24.0); p = 0.003). The metformin arm showed lower “average” and “worst” pain scores than those detected in the control arm. At the end of the paclitaxel treatment, there was a significant difference in the median serum NGF levels between the two arms, favoring metformin (p < 0.05), while NT serum levels were deemed comparable between the two study arms (p = 0.09). Conclusion: The use of metformin in breast cancer patients offered a marked protection against paclitaxel-induced PN, which translated to better patient QoL. Clinical Trial Registration: https://classic.clinicaltrials.gov/ct2/show/NCT05351021, identifier NCT05351021.

Project description:BackgroundChemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of taxane treatment and can significantly affect patient quality of life. Currently, there are no effective treatments to alleviate symptoms of CIPN; thus, starting with prevention steps in high-risk patients is considered advantageous. However, for these prevention steps to be applicable to all patients, their side effects or accompanying discomforts should be minimal, and the intervention cost-effective. Compression therapy can be considered a prevention intervention, and using surgical gloves is feasible and cost-effective (approximately $0.6 per pair). Although previous studies on compression therapy using surgical gloves have reported decreased incidence of PN, these studies were non-randomized, limited to nab-paclitaxel treatment, and involved the use of small gloves, which may have caused discomfort. Therefore, this study aimed to assess the preventive effects of compression therapy using normal-sized surgical gloves on CIPN in patients treated with paclitaxel.MethodsThis clinical trial is designed to evaluate the preventive effects of compression therapy using surgical gloves on CIPN in women with stage II-III breast cancer who received paclitaxel chemotherapy for at least 12 weeks. This multicenter, randomized-controlled, open-label study will be conducted in six academic hospitals. Patients with medication or a medical history related to neuropathy or hand disease will be excluded. The primary outcome will be the preventive effect of compression therapy using surgical gloves, measured based on changes in the neurotoxicity component of the Functional Assessment of Cancer Therapy-Taxane questionnaire. Furthermore, we will assess the National Cancer Institute's Common Terminology Criteria for Adverse Events grade of CIPN after 6 months. Notably, the estimated sample size, based on a p-value < 0.025 and statistical power of 0.9, will consist of 104 patients (52 per group), accounting for a 10% sample loss.DiscussionThis intervention can be easily implemented in clinical practice and may serve as a preventive strategy for CIPNs with strong patient adherence. If successful, this intervention could improve the quality of life and treatment adherence in patients receiving chemotherapy that can induce PN, extending beyond paclitaxel treatment alone.Trial registrationClinicalTrials.gov, NCT05771974; Registered on March 16, 2023.

Dataset Information

Effects of Cryotherapy on Objective and Subjective Symptoms of Paclitaxel-Induced Neuropathy: Prospective Self-Controlled Trial.

Background

Methods

Results

Conclusions

Publications

Effects of Cryotherapy on Objective and Subjective Symptoms of Paclitaxel-Induced Neuropathy: Prospective Self-Controlled Trial.

Similar Datasets

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