Pilot Study of Anti-Th2 Immunotherapy for the Treatment of Breast Cancer-Related Upper Extremity Lymphedema.
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SUBMITTER: Mehrara BJ
PROVIDER: S-EPMC8466465 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Breast cancer-related lymphedema is a long-term condition that affects almost half of breast cancer survivors. Clinical studies have looked at the benefits of lymphaticovenular anastomosis (LVA) for the treatment of upper extremities lymphedema after breast cancer, however, there is still controversy if it improves lymphedema. This study aimed to analyze the studies and outcomes related to LVA for breast cancer-related lymphedema. A PubMed/Medline search was performed using "lymphovenous bypass", "upper extremity lymphedema", "arm lymphedema after breast cancer treatment", and "lymphaticovenular anastomosis" as key words. Only English articles reporting outcomes after LVA were included. We found 22 articles that met the inclusion criteria. Positive outcomes were found in 21 studies with an objective volume reduction and subjective symptoms relief after LVA. This literature review concluded that LVA has demonstrated a significant decrease in upper extremity volumes and an improvement in subjectively reporting symptoms in breast cancer-related lymphedema patients.
| S-EPMC7225471 | biostudies-literature
Project description:IntroductionBreast-cancer-related upper extremity lymphoedema (BCUL), a common complication of mastectomy, can cause physical discomfort, psychological distress, cosmetic defects, functional disability and chronic recurrent erysipelas in the affected arm(s). It is a challenge to physicians involved in the management of these patients. Wuling San, a classic prescription in Traditional Chinese Medicine used in treating oedema for thousands of years, is reported by many Chinese journals to perform well in BCUL. Therefore, the aim of this study is to verify its efficacy and evaluate its safety using rigorous methodological designs in patients with BCUL.Methods and analysisTo verify the efficacy and assess the safety of Wuling San over a placebo, this double-blind, randomised, placebo-controlled, multicentre trial will be carried out in three hospitals. A total of 200 eligible patients with BCUL will be randomly allocated, in a ratio of 1:1, to either the experimental medicine group or the placebo group. The primary outcome measure will be the proportion of absolute reduced limb volume, as measured by perometry. The second outcome measure will be the number of participants with adverse events. The assessment will be carried out at the following time points: before enrolment (baseline) and 2, 4, 6 and 8 weeks after treatment.Ethics and disseminationThis trial will be conducted in accordance with the Declaration of Helsinki and supervised by the institutional review board of the Fourth Affiliated Hospital of Guangxi Medical University (approval number PJK2016088). All patients will receive information about the trial in verbal and written forms and will give informed consent before enrolment. This trial will help to demonstrate whether Wuling San is effective in the treatment of patients with BCUL. The results will be published in peer-reviewed journals or disseminated through conference presentations.Trial registration numberNCT02726477; Pre-results.
| S-EPMC5168680 | biostudies-literature
Project description:ObjectiveThe goal of this study was to develop and assess intra- and interrater reliability and validity of a clinical evaluation tool for breast cancer-related lymphedema, for use in the context of outcome evaluation in clinical trials.DesignBlinded repeated measures observational study.SettingOutpatient research laboratory.ParticipantsBreast cancer survivors with and without lymphedema (N=71).InterventionsNot applicable.Main outcome measureThe assessment of intraclass correlation coefficients (ICCs) for the Breast Cancer-Related Lymphedema of the Upper Extremity (CLUE) standardized clinical evaluation tool.ResultsIntrarater reliability for the CLUE tool was ICC: 0.88 (95% confidence interval [95% CI], 0.71-0.96). Interrater reliability for the CLUE tool was ICC: 0.90 (95% CI, 0.79-0.95). Concurrent validity of the CLUE score (Pearson r) was 0.79 with perometric interlimb difference and 0.53 with the Norman lymphedema overall score.ConclusionsThe CLUE tool shows excellent inter- and intrarater reliability. The overall CLUE score for the upper extremity also shows moderately strong concurrent validity with objective and subjective measures. This newly developed clinical, physical assessment of upper extremity lymphedema provides standardization and a single score that accounts for multiple constructs. Next steps include evaluation of sensitivity to change, which would establish usefulness to evaluate intervention efficacy.
| S-EPMC8147661 | biostudies-literature
Project description:Current treatments for lymphedema after breast cancer treatment are expensive and require ongoing intervention. Clinical experience and our preliminary published results suggest that acupuncture is safe and potentially useful. This study evaluates the safety and potential efficacy of acupuncture on upper-limb circumference in women with lymphedema.Women with a clinical diagnosis of breast cancer-related lymphedema (BCRL) for 0.5-5 years and with affected arm circumference ?2 cm larger than unaffected arm received acupuncture treatment twice weekly for 4 weeks. Affected and unaffected arm circumferences were measured before and after each acupuncture treatment. Response, defined as ?30% reduction in circumference difference between affected/unaffected arms, was assessed. Monthly follow-up calls for 6 months thereafter were made to document any complications and self-reported lymphedema status.Among 37 enrolled patients, 33 were evaluated; 4 discontinued due to time constraints. Mean reduction in arm circumference difference was 0.90 cm (95% CI, 0.72-1.07; P < .0005). Eleven patients (33%) exhibited a reduction of ?30% after acupuncture treatment. Seventy-six percent of patients received all treatments; 21% missed 1 treatment, and another patient missed 2 treatments. During the treatment period, 14 of the 33 patients reported minor complaints, including mild local bruising or pain/tingling. There were no serious adverse events and no infections or severe exacerbations after 255 treatment sessions and 6 months of follow-up interviews.Acupuncture for BCRL appears safe and may reduce arm circumference. Although these results await confirmation in a randomized trial, acupuncture can be considered for women with no other options for sustained arm circumference reduction.
| S-EPMC3738927 | biostudies-literature
Project description:This is a preliminary study to investigate the feasibility of electronic moxibustion in breast cancer patients with upper limb lymphedema. As current treatment options for lymphedema are unsatisfactory and time consuming, there have been attempts to manage symptoms using integrative treatments. Electronic moxibustion was developed to compensate for the shortcomings of conventional moxibustion and is widely used in clinical practice. However, there have been no studies on using electronic moxibustion in breast cancer-related lymphedema. To investigate the feasibility of electronic moxibustion in treating breast cancer-related lymphedema, this study included subjects who completed primary cancer treatment at least 6?months ago and had more than 10?mm difference in arm circumference of upper limbs. All subjects were assigned to the treatment group. Subjects were treated with 16 sessions (30?minutes/session) of electronic moxibustion for 8?weeks followed by 4?weeks of follow-up. For outcome measures, upper limb circumferences, shoulder range of motion, bioimpedance analysis, and quality of life questionnaire were assessed. All 10 subjects completed the study. The effective index showed 38.21% reduction after treatment (P?=?.0098) and 29.35% (P?=?.0039) after 4?weeks of follow-up compared to the baseline. The reduction of lymphedema was most prominent at 10?cm above the elbow crease, where the mean reduction of circumference difference was 7.5?mm (P?=?.0430) and continued to improve after treatment (mean reduction of 8.3?mm, P?=?.0156). There was significant improvement in shoulder range of motion only in flexion and internal rotation at week 9. There were 7 adverse events, and most were irrelevant to the treatment. Only 1 participant had a mild burn on the acupuncture point. Here, we demonstrate for the first time that electronic moxibustion treatment is a feasible treatment for breast cancer-related lymphedema. Electronic moxibustion may reduce differences in upper limb circumference and improve shoulder range of motion. A future comparative clinical trial is needed to confirm the clinical efficacy of this treatment.
| S-EPMC7570305 | biostudies-literature
Project description:The purpose of this study was to evaluate trajectories of and predictors for changes in upper extremity (UE) function in women (n = 396) during the first year after breast cancer treatment.Prospective, longitudinal assessments of shoulder range of motion (ROM), grip strength, and perceived interference of function were performed before and for 1 year after surgery. Demographic, clinical, and treatment characteristics were evaluated as predictors of postoperative function.Women had a mean (SD) age of 54.9 (11.6) years, and 64% were white. Small but statistically significant reductions in shoulder ROM were found on the affected side over 12 months (P < 0.001). Predictors of interindividual differences in ROM at the 1-month assessment were ethnicity, neoadjuvant chemotherapy, type of surgery, axillary lymph node dissection, and preoperative ROM. Predictors of interindividual differences in changes over time in postoperative ROM were living alone, type of surgery, axillary lymph node dissection, and adjuvant chemotherapy. Declines in mean grip strength from before through 1 month after surgery were small and not clinically meaningful. Women with greater preoperative breast pain interference scores had higher postoperative interference scores at all postoperative assessments.Some of the modifiable risk factors identified in this study can be targeted for intervention to improve UE function in these women.
| S-EPMC4967035 | biostudies-literature
Project description:PurposeTo quantify chemical exchange saturation transfer contrast in upper extremities of participants with lymphedema before and after standardized lymphatic mobilization therapy using correction procedures for B0 and B1 heterogeneity, and T1 relaxation.MethodsFemales with (n = 12) and without (n = 17) breast cancer treatment-related lymphedema (BCRL) matched for age and body mass index were scanned at 3.0T MRI. B1 efficiency and T1 were calculated in series with chemical exchange saturation transfer in bilateral axilla (B1 amplitude = 2µT, Δω = ±5.5 ppm, slices = 9, spatial resolution = 1.8 × 1.47 × 5.5 mm3 ). B1 dispersion measurements (B1 = 1-3 µT; increment = 0.5 µT) were performed in controls (n = 6 arms in 3 subjects). BCRL participants were scanned pre- and post-manual lymphatic drainage (MLD) therapy. Chemical exchange saturation transfer amide proton transfer (APT) and nuclear Overhauser effect (NOE) metrics corrected for B1 efficiency were calculated, including proton transfer ratio (PTR'), magnetization transfer ratio asymmetry (MTRasymmetry') , and apparent exchange-dependent relaxation (AREX'). Nonparametric tests were used to evaluate relationships between metrics in BCRL participants pre- versus post-MLD (two-sided P < 0.05 required for significance).ResultsB1 dispersion experiments showed nonlinear dependence of Z-values on B1 efficiency in the upper extremities; PTR' showed < 1% mean fractional difference between subject-specific and group-level correction procedures. PTR'APT significantly correlated with T1 (Spearman's rho = 0.57, P < 0.001) and body mass index (Spearman's rho = -0.37, P = 0.029) in controls and with lymphedema stage (Spearman's rho = 0.48, P = 0.017) in BCRL participants. Following MLD therapy, PTR'APT significantly increased in the affected arm of BCRL participants (pre- vs. post-MLD: 0.41 ± 0.05 vs. 0.43 ± 0.03, P = 0.02), consistent with treatment effects from mobilized lymphatic fluid.ConclusionChemical exchange saturation transfer metrics, following appropriate correction procedures, respond to lymphatic mobilization therapies and may have potential for evaluating treatments in participants with secondary lymphedema.
| S-EPMC6982565 | biostudies-literature
Project description:PurposeThe aims of this study were to investigate if/how the presence of lymphedema affects the sensation of the upper limb and to assess whether complex decongestive physiotherapy (CDP) has a favorable impact on sensory testing.MethodsA total of 27 patients with unilateral stage 2 breast cancer-related lymphedema (BCRL) were included in the study. Bilateral circumferential measurements were taken with a tape measure at different levels. Based on these measurements, limb volumes were determined by summing segment volumes derived from the truncated cone formula. Circumferential measurements and ultrasonographic evaluations (epidermis, dermis, and subcutaneous fat thicknesses) were performed at 10 cm distal to the elbow crease. The Semmes-Weinstein monofilament (SWM), static and moving two-point discrimination, pressure pain threshold (PPT), and tactile localization tests were also applied at the same site. After an initial evaluation, all patients underwent CDP phase 1 program. All the evaluations were repeated at the end of the treatment period.ResultsBefore CDP, affected sides had significantly higher values than the unaffected sides in terms of SWM (p < 0.001), static (p = 0.002) and moving (p = 0.011) two-point discrimination, PPT (p = 0.001), and tactile localization (p < 0.001) values. After CDP, SWM (p = 0.002), static (p = 0.009) and moving (p = 0.024) two-point discrimination, PPT (p = 0.014), and tactile localization (p < 0.001) values decreased significantly on the affected sides.ConclusionBCRL seems to reduce light touch, static and moving two-point discrimination, PPT, and tactile localization sensations, whereas CDP seems to improve these sensory perceptions in women with BCRL. Ultrasonographic measurements also appear to be promising for prompt and convenient follow-up in the management of BCRL.Trial registrationClinical Trial Registration Number: NCT04296929 (date of registration: March 5, 2020).
| S-EPMC8081563 | biostudies-literature
Project description:BACKGROUND:Although superficial thrombophlebitis of the upper extremity represents a frequent complication of intravenous catheters inserted into the peripheral veins of the forearm or hand, no consensus exists on the optimal management of this condition in clinical practice. OBJECTIVES:To summarise the evidence from randomised clinical trials (RCTs) concerning the efficacy and safety of (topical, oral or parenteral) medical therapy of superficial thrombophlebitis of the upper extremity. SEARCH METHODS:The Cochrane Vascular Group Trials Search Co-ordinator searched the Specialised Register (last searched April 2015) and the Cochrane Register of Studies (2015, Issue 3). Clinical trials registries were searched up to April 2015. SELECTION CRITERIA:RCTs comparing any (topical, oral or parenteral) medical treatment to no intervention or placebo, or comparing two different medical interventions (e.g. a different variant scheme or regimen of the same intervention or a different pharmacological type of treatment). DATA COLLECTION AND ANALYSIS:We extracted data on methodological quality, patient characteristics, interventions and outcomes, including improvement of signs and symptoms as the primary effectiveness outcome, and number of participants experiencing side effects of the study treatments as the primary safety outcome. MAIN RESULTS:We identified 13 studies (917 participants). The evaluated treatment modalities consisted of a topical treatment (11 studies), an oral treatment (2 studies) and a parenteral treatment (2 studies). Seven studies used a placebo or no intervention control group, whereas all others also or solely compared active treatment groups. No study evaluated the effects of ice or the application of cold or hot bandages. Overall, the risk of bias in individual trials was moderate to high, although poor reporting hampered a full appreciation of the risk in most studies. The overall quality of the evidence for each of the outcomes varied from low to moderate mainly due to risk of bias and imprecision, with only single trials contributing to most comparisons. Data on primary outcomes improvement of signs and symptoms and side effects attributed to the study treatment could not be statistically pooled because of the between-study differences in comparisons, outcomes and type of instruments to measure outcomes.An array of topical treatments, such as heparinoid or diclofenac gels, improved pain compared to placebo or no intervention. Compared to placebo, oral non-steroidal anti-inflammatory drugs reduced signs and symptoms intensity. Safety issues were reported sparsely and were not available for some interventions, such as notoginseny creams, parenteral low-molecular-weight heparin or defibrotide. Although several trials reported on adverse events with topical heparinoid creams, Essaven gel or phlebolan versus control, the trials were underpowered to adequately measure any differences between treatment modalities. Where reported, adverse events with topical treatments consisted mainly of local allergic reactions. Only one study of 15 participants assessed thrombus extension and symptomatic venous thromboembolism with either oral non-steroidal anti-inflammatory drugs or low-molecular-weight heparin, and it reported no cases of either. No study reported on the development of suppurative phlebitis, catheter-related bloodstream infections or quality of life. AUTHORS' CONCLUSIONS:The evidence about the treatment of acute infusion superficial thrombophlebitis is limited and of low quality. Data appear too preliminary to assess the effectiveness and safety of topical treatments, systemic anticoagulation or oral non-steroidal anti-inflammatory drugs.
| S-EPMC6885032 | biostudies-literature
Project description:The aim of this study was to determine whether adherence to self-care modalities for breast cancer-related lymphedema (BCRL) predicts BCRL outcomes among 128 breast cancer survivors who participated in the 12-mo physical activity and lymphedema trial.This was a prospective cohort study. Adherence to ten BCRL self-care modalities, as recommended in the clinical practice guidelines for the management of BCRL, was assessed by a questionnaire at baseline. BCRL outcomes assessed at baseline and 12 mos included volumetry, circumferences, bioimpedence spectroscopy, the Norman lymphedema survey, and therapist-defined lymphedema exacerbations requiring treatment. Generalized linear models were used to estimate the relationship between adherence to BCRL self-care modalities and the likelihood of experiencing a BCRL outcome.Adherence to BCRL self-care activities did not predict experiencing any BCRL outcomes at 12 mos. Levels of adherence to BCRL self-care modalities did not predict a 5% or greater decrease in interlimb volume (Ptrend = 0.79), 5% or greater decrease in the sum of interlimb arm circumferences (Ptrend = 0.47), 10% or greater decrease in bioimpedence spectroscopy (Ptrend = 0.83), 1 or greater decrease in self-reported lymphedema symptoms (Ptrend = 0.91), or therapist-defined lymphedema exacerbation requiring treatment (Ptrend = 0.84).Our findings suggest that levels of BCRL self-care adherence do not predict BCRL outcomes among breast cancer survivors with stable lymphedema who were followed for 12 mos.
| S-EPMC4344918 | biostudies-literature