Microbiome-Modifiers for Cancer-Related Fatigue Management: A Systematic Review.

OBJECTIVES: This study systematically investigates the evidence regarding the use of probiotics in managing cancer-related fatigue (CRF). STUDY DESIGN: We conducted a systematic review of randomized controlled trials. DATA SOURCES: The systematic search encompassed six databases: PubMed, CINHAL, Cochrane Database of Systematic Reviews, Web of Science, Scopus, and EMBASE, covering the period from inception to December 2023. The assessment of risk of bias employed the Cochrane risk of bias tool (RoB 2). A narrative synthesis and an exploratory meta-analysis were conducted to summarize the evidence. RESULTS: Among 460 records, three studies met the eligibility criteria and were included in the review. These studies involved a total of 284 participants with colorectal and breast cancer. One study demonstrated a marginal improvement in CRF postchemotherapy in colorectal cancer patients using probiotics. Another study, also using probiotics, reported a significant reduction in CRF among colorectal cancer patients undergoing chemotherapy. Additionally, a study employing synbiotics showed a substantial decrease in CRF severity in breast cancer patients receiving chemotherapy. CONCLUSION: The study presents initial but varied evidence suggesting the potential of probiotics and synbiotics as adjunctive therapies in managing CRF alongside anticancer treatments. IMPLICATIONS FOR NURSING PRACTICE: In nursing practice, large-scale clinical trials are urgently needed to evaluate the effectiveness of probiotics in treating cancer-related fatigue during cancer therapy. Insights from this review could guide nurses in selecting appropriate probiotic strains and integrating microbiome modifiers into comprehensive care plans, potentially enhancing the quality of life for cancer patients.

Post-diagnosis serum 25-hydroxyvitamin D concentrations in women treated for breast cancer participating in a lifestyle trial in Italy.

OBJECTIVE: To report cross-sectionally serum levels of 25-hydroxyvitamin D [25(OH)D] in women living in Italy within 12 months from breast cancer (BC) diagnosis. METHODS: Baseline data were obtained from 394 women diagnosed with primary BC, enrolled from 2016 to 2019 in a lifestyle trial conducted in Italy. Subjects' characteristics were compared between two 25(OH)D concentrations (hypovitaminosis D<20 and ≥20 ng/mL) with the Chi-squared test or Fisher's exact test for small-expected counts. Using multiple logistic regression-adjusted models, we estimated odds ratios (ORs) of hypovitaminosis D with 95% confidence intervals (CIs) in the total sample and in the unsupplemented subgroup. RESULTS: Hypovitaminosis D was found in 39% of all subjects, 60% in unsupplemented subjects, and 10% in supplemented subjects. Increasing ORs of hypovitaminosis D were found with increasing body mass index, 25-30, >30, and ≥35 versus <25 kg/m2 (ORs: 2.50, 4.64, and 5.81, respectively, in the total cohort and ORs: 2.68, 5.38, and 7.08 in the unsupplemented); living in the most southern Italian region (OR 2.50, 95%CI 1.22-5.13); and with hypertriglyceridemia (OR 2.46; 95%CI 1.16-5.22), chemotherapy history (OR 1.86, 95%CI 1.03-3.38), and inversely with anti-estrogenic therapy (OR 0.43, 95%CI 0.24-0.75) in the total sample. CONCLUSIONS: Hypovitaminosis D in women recently diagnosed with BC and participating in a lifestyle trial in Italy was widespread and highest with obesity, hypertriglyceridemia, and chemotherapy use. Considering that hypovitaminosis D is a risk factor for lower efficacy of bone density treatments and possibly BC mortality, our results suggest the need to promptly address and treat vitamin D deficiency.

Severe hyponatremia and diabetes insipidus caused by low-dose cyclophosphamide in breast cancer patients: A case report and literature review.

RATIONALE: Cyclophosphamide (CTX) is widely used in the treatment of malignancies and autoimmune diseases. Although severe hyponatremia caused by low-dose CTX chemotherapy is uncommon, it can lead to serious complications and even death. PATIENT CONCERNS: A 44-year-old woman with left-sided breast cancer suddenly experienced headaches, disorientation and weakness after receiving low-dose neoadjuvant chemotherapy combined with CTX and doxorubicin. DIAGNOSES: The patient pathology showed invasive breast carcinoma. She developed severe hyponatremia and a generalized seizure after completing the first cycle of neoadjuvant chemotherapy with CTX and doxorubicin. Laboratory tests showed a serum sodium of 118 mmol/L (normal range 135-145 mmol/L) and potassium sodium 3.16 mmol/L (normal range 3.5-5.5 mmol/L). Subsequently, the patient developed secondary diabetes insipidus 4 hours after sodium supplementation, her 24-hour urine volume was 4730 mL (normal range 1000-2000 mL/24 hours), and the urine specific gravity decreased to 1.005. INTERVENTIONS: The patient was given intravenous sodium chloride (500 mL of 3%NaCl, 100 mL/hour) and potassium chloride (500 mL of 0.3%KCl, 250 mL/hour). Meanwhile, she was advised to reduce her water intake, and pituitrin was administered to prevent dehydration caused by diabetes insipidus. OUTCOMES: The patient completely recovered after correcting of the serum sodium concentration (137 mmol/L) without any neurological deficits. After discontinuing pituitrin, her 24-hour urine volume was 2060 mL and the urine specific gravity was 1.015. LESSONS: This is a typical case of severe hyponatremia induced by low-dose CTX. Clinicians and healthcare providers should be aware of this potential toxicity, and appropriate monitoring should be implemented.

Effects of Pilates method on quality of life, fatigue and sleep quality among breast cancer women receiving hormone therapy - Two-arm randomized clinical trial.

OBJECTIVE: To analyze the effect of the Pilates method on the quality of life, fatigue, and sleep quality of patients undergoing adjuvant clinical treatment with hormone therapy for breast cancer. METHODS: A randomized two-arm clinical trial with 34 breast cancer women that were randomized into two groups: a) Intervention group, who performed 16 weeks of mat Pilates; b) Control group, who maintained their daily routine activities and received three educational sessions. The questionnaires for each variable were applied before the intervention, after the intervention, and six months after the end of the intervention. Quality of life was assessed by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30), fatigue by the Functional Assessment of Cancer Therapy-Fatigue (FACT-F), and sleep quality by the Pittsburgh Sleep Quality Index. RESULTS: The fatigue variable presented a time effect (p = 0.034) regardless of the analyzed group, in which a difference was found between baseline and the post-intervention period (p = 0.037). The variable sleep showed an effect of time (p = 0.025), presenting a difference between the baseline period and six months, with improvement for all participants (p = 0.004). Global health also showed a positive change also for all participants, with an isolated effect of time (p = 0.024). CONCLUSION: Interventions based on the Pilates method may bring positive results in quality of life, fatigue, and sleep quality in patients undergoing adjuvant treatment for breast cancer, but further studies on the subject are needed to prove the results in a larger number of patients.

Shoulder and scapulothoracic impairments in women with breast cancer-related lymphedema in the upper limb: A cross-sectional study shoulder and breast cancer-related lymphedema.

INTRODUCTION: Lymphedema in the upper limb as a complication of breast cancer may lead to shoulder pain and dysfunctions. OBJECTIVE: To compare the scapular positioning, the shoulder range of motion, and muscle strength among women undergoing treatment for breast cancer with and without lymphedema and a control group. METHODS: This cross-sectional study evaluated women undergoing treatment for breast cancer (N = 25) and without lymphedema (N = 25), and a control group (N = 25). Static scapular positions and shoulder range of motion were measured by using an inclinometer. The shoulder and periscapular muscle strength were measured by using a hand-held dynamometer and the Disabilities of the Arm, Shoulder, and Hand Questionnaire was applied. Linear regression of the mixed effects model was used to compare the groups. RESULTS: Both groups of mastectomized women had reduced shoulder range of motion, scapular upward rotation, and muscle strength for shoulder and periscapular muscles compared to the control group. Also, women undergoing treatment for breast cancer with lymphedema had reduced shoulder range of motion, scapular upward rotation, increased anterior tilt, reduced muscle strength of the upper trapezius, and greater upper limb disability compared to women without lymphedema. CONCLUSION: Women undergoing treatment for breast cancer with lymphedema had even greater shoulder and scapulothoracic impairments when compared to the control group and women without lymphedema.

A randomized comparison of online mindfulness-based group sex therapy vs supportive group sex education to address sexual dysfunction in breast cancer survivors.

BACKGROUND: Sexual difficulties and vaginal pain are common following treatment for breast cancer. AIM: The goal of this study was to evaluate an online mindfulness-based group sex therapy vs an online supportive sex education group therapy to address these sexual difficulties. METHODS: Breast cancer survivors (n = 118) were randomized to 1 of the 2 arms; 116 provided informed consent and completed the time 1 assessment. Treatment included 8 weekly 2-hour online group sessions. Those randomized to the mindfulness group completed daily mindfulness exercises, and those in the comparison arm read and completed exercises pertaining to sex education. OUTCOMES: Assessments were repeated at posttreatment and 6 months after the completion of the group. RESULTS: There was a main effect of treatment on primary endpoints of sexual desire, sexual distress, and vaginal pain, with all outcomes showing significant improvements, with no differential impact by treatment arm. Secondary endpoints of interoceptive awareness, mindfulness, and rumination about sex also significantly improved with both treatments, with no group-by-time interaction. CONCLUSION: Both mindfulness-based sex therapy and supportive sex education delivered in group format online are effective for improving many facets of sexual function, vaginal pain, rumination, mindfulness, and interoceptive awareness in breast cancer survivors. STRENGTHS AND LIMITATIONS: We used a randomized methodology. Future studies should seek to diversify participants. CLINICAL IMPLICATIONS: These findings highlight the need to offer similar treatments to more breast cancer survivors immediately after and in the years following cancer treatment as a means of improving survivorship quality of life.

Efficacy of Moxibustion for Cancer-Related Fatigue in Patients with Breast Cancer: A Systematic Review and Meta-Analysis.

INTRODUCTION: Breast cancer is the most commonly diagnosed cancer worldwide, and most patients experience fatigue. However, there are no effective treatments for cancer-related fatigue (CRF). Several randomized controlled trials (RCTs) have suggested that moxibustion improves CRF. We conducted a systematic review and meta-analysis to compare the differences in fatigue scale scores, quality of life, and clinical efficacy in patients with breast cancer who developed CRF and did versus did not receive moxibustion. METHODS: RCTs were searched in 7 databases using a standardized search method from database inception to March 2023, and RCTs that met the inclusion criteria were selected. RESULTS: Among 1337 initially identified RCTs, 10 RCTs involving 744 participants were selected for this study. The meta-analysis involved assessment of the revised Piper Fatigue Scale scores, Cancer Fatigue Scale scores, Karnofsky Performance Scale scores, Athens Insomnia Scale scores, clinical efficacy, and Qi deficiency syndrome scale scores. Compared with the control, moxibustion was associated with significantly better Piper Fatigue Scale scores (P < 0.0001), quality of life [Karnofsky Performance Scale scores (P < 0.0001)], clinical efficacy (P = 0.0007), and Qi deficiency syndrome scale scores (P = 0.02). CONCLUSIONS: Moxibustion improves CRF in patients with breast cancer. The efficacy of moxibustion should be further examined by high-quality studies in various countries with patients subdivided by their breast cancer treatment status. REGISTRATION: PROSPERO ID: CRD42023451292.

Safety and efficacy of non-ablative CO2 laser treatment of vulvo-vaginal atrophy in women with history of breast cancer.

PURPOSE: Breast cancer survivors (BCS) suffer severe vulvo-vaginal atrophy (VVA) and some of the most effective therapies are contraindicated. In literature we have no data about the non-ablative CO2 laser on these women. The aim of this study was to examine its efficacy, safety and acceptability in BCS. MATERIALS AND METHODS: The enrolled women underwent 3 sessions of laser therapy (t0, t1, t2) and a one-month follow up examination (t3). At each time point we measured objective signs of VVA via VHI (Vaginal Health Index) and VuHI (Vulvar Health Index) and subjective parameters (Dryness, Burning, Itching, Dysuria) via visual analog scales (VAS). In sexually active women we evaluated the sexual function with FSFI (Female Sexual Function Index), FSDS (Female Sexual Distress Score) scores and MENQOL (menopause quality of life questionnaire). RESULTS: We enrolled 26 BCS. The mean VHI, VuVHI, dryness and burning VAS scores improved significantly and this improvement was not influenced by the initial VVA grade. MENQOL sexual domain, Lubrication, Orgasm and Pain domains and FSFI total score improved significantly, while Desire, Arousal and Satisfaction domains of FSFI and FSDS did not. At t0 women using Aromatase Inhibitors suffered more severe vaginal dryness than women using Tamoxifen or no therapy, but the three subgroups improved without differences. No adverse event and minimum discomfort were reported. CONCLUSIONS: The non-ablative CO2 laser is a safe and effective treatment of VVA and has positive effects on sexual function in BCS regardless the use of adjuvant therapies and the initial grade of VVA.

Multi-center retrospective review of vitiligo-like lesions in breast cancer patients treated with cyclin-dependent kinase 4 and 6 inhibitors.

PURPOSE: Cutaneous adverse effects from cyclin-dependent 4 and 6 kinase inhibitors (CDK4/6i) used in metastatic breast cancer are prevalent and well described. Vitiligo-like lesions have been reported and are rare. They can negatively impact patients' quality of life and may be associated with survival benefits. We describe the clinical characteristics of vitiligo-like lesions in an international cohort of patients treated with CDK4/6i to help improve recognition and management. METHODS: Retrospective review of patients diagnosed with vitiligo-like lesions from CDK4/6i from five academic institutions in the USA and Europe was performed. Ten patients were included in the study. RESULTS: Median age of our patients was 55 (range 37-86). Median progression-free survival was 24 months in 5 patients. The median time to rash was 10 months. Sun-exposed areas such as the arms and face were the most affected areas. Multiple skin-directed therapies such as topicals, laser, and phototherapy were trialed with minor success. Mild repigmentation was seen in one patient treated with ruxolitinib cream. CDK4/6 treatment was discontinued due to the vitiligo-like lesions in one patient. CONCLUSION: Clinical characteristics are similar to previously reported findings in case reports and series. We add topical ruxolitinib as a potential treatment option for these patients and include data regarding progression-free survival that should continue to be collected. No definitive conclusions can be made regarding survival benefits from our cohort. Clinicians should refer these patients to dermatologists to aid with management.

[Radiation-induced morphea-an overview]. / Postradiogene Morphea ­ eine Übersicht.

BACKGROUND: Radiation-induced morphea is a fibro-inflammatory remodelling process of the subcutaneous connective tissue caused by ionising radiation, most commonly in the context of breast cancer treatment. The underlying pathomechanisms and putative risk factors are unknown. Therefore, misdiagnosis and inappropriate treatment pose a significant problem in the care of those patients. OBJECTIVES: The aim of the study was to provide an overview as well as guidance for the diagnosis and treatment of radiation-induced morphea based on current case reports and review articles. RESULTS AND CONCLUSIONS: Radiation-induced morphea is a rare condition that represents an interdisciplinary challenge for (gynaecological) oncology, radiotherapy and dermatology. Frequent misdiagnoses include infection (erysipelas), cancer recurrence or radiation dermatitis. Early histological diagnosis and the initiation of anti-inflammatory therapy using topical glucocorticoids or calcineurin inhibitors in combination with phototherapy and/or methotrexate are the most relevant success factors for an adequate clinical response.

Efficacy of an aloe vera, chamomile, and thyme cosmetic cream for the prophylaxis and treatment of mild dermatitis induced by radiation therapy in breast cancer patients: a controlled clinical trial (Alantel Trials).

BACKGROUND: Dermatitis is a skin condition caused by multiple causes, including radiotherapy treatment. Pharmacological treatments can become chronic and are not exempt from side effects. The latest recommendations of the American Academy of Dermatology establish the use of natural, nourishing, and moisturizing cosmetic products as prevention and the first therapeutic step for dermatitis. Alantel® is a cream developed to reduce redness and irritation, promote the local immune system, combat immunosenescence, and promote the healing of epidermal lesions. The objective was to evaluate the effect of a cream (Alantel) based on natural products at high concentrations for the preventive and curative treatment (at early stages) of radiation-induced dermatitis in patients with breast cancer. METHODS: Our protocol is an experimental, prospective, triple-blind, multicenter, controlled clinical trial with two parallel arms. The experimental group will be treated with Alantel, while the control group will receive another moisturizing cream. Radiotherapy oncology professionals will recruit a total of 88 patients (44 per comparison group) with breast cancer who will receive radiotherapy oncology treatment for 15 days, and they will be randomly allocated to the experimental or control group. Selected patients will be followed up for four visits by primary care physicians for up to 1 week after completion of radiotherapy. The main study variable will be the incidence rate of mild post-radiation dermatitis. An intention-to-treat analysis will be performed, applying a comparison test for independent means and proportions. A bivariate and multivariate analysis will also be developed to check the treatment effect, adjusting for predictive sociodemographic and clinical variables. DISCUSSION: By carrying out this clinical trial, it is expected to verify that Alantel cream, based on natural products at high concentrations, has advantages over a moisturizing cream for the preventive and curative treatment of RD in patients with breast cancer. The COVID-19 pandemic has been influenced by delaying the start of the study. One of the main limitations of this study will be the time required to recruit the patients from the planned sample, given that the selection criteria are restrictive and, although the study is multicenter, recruitment will be coordinated through a single service on radiotherapy oncology. TRIAL REGISTRATION: ClinicalTrials.gov NCT04116151 . Registered on 4 October 2019.

Effect of yoga on cancer-related fatigue in patients with breast cancer: A systematic review and meta-analysis.

BACKGROUND: Breast cancer is a common malignant tumor in women and most patients with breast cancer experience fatigue. Numerous studies have investigated the relationship between yoga and cancer-related fatigue (CRF) in patients with breast cancer. However, these studies drew their conclusions from small sample sizes and lacked sufficient evidence to demonstrate that yoga can effectively alleviate CRF. Therefore, this meta-analysis aims to systematically examine the effects of yoga on cancer fatigue in patients with breast cancer and establish a scientific basis for enhancing their quality of life. OBJECTIVE: To assess the effect of yoga on CRF in patients with breast cancer. METHODS: Computer searches were conducted on PubMed, Embase, Web of Science, CKNI, and Wanfang databases to retrieve articles related to yoga and CRF in patients with breast cancer from the hospital establishment date to July 2023. The literature was independently screened, and the information was extracted by the researchers. A meta-analysis was conducted using Review Manager Software (version 5.3). RESULTS: The findings from the meta-analysis of 18 studies indicate that yoga can effectively enhance CFR (standardized mean difference (SMD) = -0.51, 95% confidence interval [CI] = -0.92 to -0.10), improve sleep quality (MD = -3.86, 95%CI = -4.03 to -3.70) in patients with breast cancer, alleviate anxiety and depression (SMD = -0.93, 95%CI = -1.68, -0.18, SMD = -1.23, 95%CI = -2.02 to -0.44), and enhance quality of life (MD = -11.20, 95%CI = -14.16 to -8.24). CONCLUSION: Our study offers evidence for the subsequent reduction of CFR in patients with breast cancer. Yoga can alleviate fatigue, improve sleep quality and negative emotions, and improve the quality of life of patients with breast cancer.

Fat Body Mass and Vertebral Fracture Progression in Women With Breast Cancer.

Importance: Women with early breast cancer (EBC) exposed to aromatase inhibitors (AIs) may experience fragility fractures despite treatment with bone-active drugs. Risk factors for fractures in patients receiving AIs and denosumab have not been explored to date. Objectives: To evaluate whether an association exists between dual x-ray absorptiometry (DXA)-measured fat body mass (FBM) and vertebral fracture (VF) progression in postmenopausal women with EBC undergoing adjuvant therapy with AIs in combination with denosumab and to examine whether VF was associated with common risk factors for bone fracture and parameters of body composition other than FBM. Design, Setting, and Participants: For this prospective, single-center, cohort study, 237 patients with EBC who were undergoing adjuvant treatment with AIs and denosumab (60 mg every 6 months) were enrolled at the Breast Unit of the ASST Spedali Civili of Brescia from September 2014 to June 2018. Data analysis was conducted in June 2022. Exposure: Body composition parameters, bone mineral density, and morphometric VFs were assessed by DXA at study entry and after 18 months of therapy. Main Outcomes and Measures: VF progression, defined as either new or worsening of preexisting VFs, between the 2 time points. Results: Of the 237 patients enrolled (median [range] age, 61 [28-84] years), 17 (4.4%) reported VF progression. Univariable analysis found an association between VF progression and a history of clinical fractures (odds ratio [OR], 3.22; 95% CI, 1.19-8.74; P = .02), Fracture Risk Assessment Tool (FRAX) score for major fractures (OR, 4.42; 95% CI, 1.23-13.79; P = .04), percentage of FBM (OR, 6.04; 95% CI, 1.69-21.63; P = .006), and android fat (OR, 9.58; 95% CI, 1.17-78.21; P = .04) and an inverse association with appendicular lean mass index-FBM ratio (OR, 0.25, 95% CI, 0.08-0.82; P = .02). Multivariable analysis revealed percentage of FBM (OR, 5.41; 95% CI, 1.49-19.59; P = .01) and FRAX score (OR, 3.95; 95% CI, 1.09-14.39; P = .04) as independent variables associated with VF progression. Conclusions and Relevance: The findings of this study suggest that baseline FBM is an independent factor for VF progression in patients with EBC treated with adjuvant AIs and denosumab. This observation is new and indicates that diet and exercise may synergize with denosumab in the management of bone health in this patient setting.

Initiating and Maintaining Complete Decongestive Therapy Self-Management of Lymphedema Among Breast Cancer Survivors: Descriptive Qualitative Study.

PURPOSE: This study aimed to identify determinants that promote the initiation and maintenance of complete decongestive therapy (CDT) as well as effective strategies for mitigating barriers to self-management of lymphedema among breast cancer survivors. METHODS: A descriptive and qualitative design was used. In-depth interviews were conducted with 13 breast cancer survivors who were managing breast cancer-related lymphedema. Interviews were transcribed verbatim. An iterative descriptive data analysis method was employed to examine the data, compare codes, challenge interpretations, and inductively identify themes. RESULTS: A realization that lymphedema requires daily self-management was the primary determinant leading breast cancer survivors to initiate CDT self-management. The determinants for maintaining daily CDT self-management included the perceived effectiveness of CDT, being willing to assume accountability, and perceived efficacy to undertake CDT. Developing strategies to integrate CDT regimens into daily life is key to maintaining CDT self-management of lymphedema. Three core concepts mediate initiation and maintenance of CDT self-management: understanding lymphedema as a chronic condition that can be managed with CDT self-management, being worried about lymphedema exacerbation, and having support from patient peers and family. CONCLUSIONS: Interventions should be tailored to promote the initiation and maintenance of CDT self-management. While clinicians provided knowledge-based and clinical skills-based information, patient peers provided daily life examples, and real-life implementation strategies for CDT self-management. Ongoing patient-provider and patient-peer communication functioned as effective support for maintaining CDT self-management. Reliable and realistic methods of symptom self-assessment are important for maintaining CDT at home.

Women's cardiovascular health - the cardio-oncologic jigsaw.

Improvements in cancer care have led to an exponential increase in cancer survival. This is particularly the case for breast cancer, where 5-year survival in Australia exceeds 90%. Cardiovascular disease (CVD) has emerged as one of the competing causes of morbidity and mortality among cancer survivors, both as a complication of cancer therapies and because the risk factors for cancer are shared with those for CVD. In this review we cover the key aspects of cardiovascular care for women throughout their cancer journey: the need for baseline cardiovascular risk assessment and management, a crucial component of the cardiovascular care; the importance of long-term surveillance for ongoing maintenance of cardiovascular health; and strong evidence for the beneficial effects of physical exercise to improve both cancer and cardiovascular outcomes. There is general disparity in cardiovascular outcomes for women, which is further exacerbated when both CVD and cancer co-exist. Collaboration between oncology and cardiac services, with an emergence of the whole field of cardio-oncology, allows for expedited investigation and treatment for these patients. This collaboration as well as a holistic approach to patient care and key role of patients' general practitioners are essential to ensure long-term health of people living with, during and beyond cancer.

Melatonin Supplementation for Cancer-Related Fatigue in Patients With Early Stage Breast Cancer Receiving Radiotherapy: A Double-Blind Placebo-Controlled Trial.

BACKGROUND: Fatigue is common in patients undergoing radiotherapy (RT) and can significantly impact quality of life. Melatonin, a safe inexpensive natural supplement, may improve symptoms and attenuate the side effects of RT. The purpose of this randomized double-blind placebo-controlled phase III trial was to assess the effects of melatonin for preventing fatigue and other symptoms in patients with breast cancer undergoing RT. METHODS: Female early stage or Ductal carcinoma in situ patients with breast cancer ≥18 years of age with Eastern Cooperative Oncology Group (ECOG) performance status <3, hemoglobin ≥9 g/dL, planned for outpatient RT treatment with curative intent, were randomized 1:1 to melatonin 20 mg or placebo, orally, starting the night before RT initiation until 2 weeks post-RT. Randomization was stratified according to treatment duration (<3 weeks, ≥3 weeks) and prior chemotherapy. The primary endpoint was the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue scale), and secondary endpoints were FACIT-F subscales, Edmonton Symptom Assessment Scale (ESAS), and Patient-Reported Outcomes Measurement Information System (PROMIS) scores obtained at baseline, and 2 and 8 weeks post-RT. A 2-sided ANOVA F-test at a 4.5% significance level for the primary endpoint was used. Secondary analyses were reported using an F-test at a 5% significance level. The goal was to recruit approximately 140 patients with interim analysis planned mid-recruitment. RESULTS: Eighty-five patients were screened for eligibility; 79 patients were randomized: 40 to melatonin and 39 to placebo; 78 patients were treated and included in the interim analysis at the mid-recruitment point. Baseline patient characteristics of age, race, and ECOG performance status were similar in both arms. The treatment effect was studied using a longitudinal mixed effects model with the effect of treatment over time (treatment × time) as the primary outcome parameter. The treatment × time for FACIT-Fatigue did not demonstrate statistical significance (P-value .83) in the melatonin group compared to placebo. In addition, secondary analyses of FACIT physical, social, emotional, and functional well-being scores did not demonstrate statistical significance (P-values of .35, .06, .62, and .71, respectively). Total PROMIS scores, collected as secondary outcome reported by patients, did not demonstrate statistically significant change over time either (P-value is .34). The other secondary scale, ESAS, was analyzed for each individual item and found to be nonsignificant, anxiety (P = .56), well-being (.82), drowsiness (.83), lack of appetite (.35), nausea (.79), pain (.50), shortness of breath (.77), sleep (.45), and tiredness (.56). Depression was the only item demonstrating statistical significance with a decrease of 0.01 unit in the placebo group, a change not considered clinically significant. Melatonin was well-tolerated with no grade 3 or 4 adverse events reported. The most common side effects were headache, somnolence, and abdominal pain. No patients died while participating in this study. Two patients died within a year of study completion from breast cancer recurrence. Sixteen patients withdrew prior to study completion for various reasons including adverse events, hospitalizations unrelated to study drug, RT discontinuation, and COVID-19 precautions. CONCLUSIONS: In this double-blind placebo-controlled phase III trial, melatonin did not prevent or significantly improve fatigue and other symptoms in patients with early stage breast cancer undergoing RT. The analysis, showing little evidence of an effect, at mid-recruitment, assured early termination of the trial.

Percutaneous electrical nerve stimulation in post-mastectomy neuropathic pain: A case report.

Post-mastectomy pain syndrome (PMPS) is a type of chronic postsurgical pain that can be severe, debilitating and frequently encountered in clinical practice. Multiple studies have focused on prevention, identifying risk factors and treating this condition. Nonetheless, PMPS remains a complex condition to treat effectively. In this case report, we describe the use of percutaneous electrical nerve stimulation in a breast cancer patient who experienced PMPS refractory to conventional treatments.

The Effect of Art Therapy on Pain, Emesis, Anxiety, and Quality of Life in Operated Breast Cancer Patients: Randomized Control Trials.

Background: Breast cancer symptoms related to the disease nature and treatments develop and the quality of life of patients is impacted. Art therapy improves the quality of life by increasing symptom control and treatment compliance. This study aimed to determine the effect of art therapy on pain, emesis, anxiety, and quality of life in operated breast cancer patients. Methods: This experimental research was carried out with a total of 60 patients, 30 in the intervention group (IG) and 30 in the control group (CG), who received treatment in the Oncology Center of Sivas Cumhuriyet University Practice and Research Hospital. A Personal Information Form, the Pain Intensity-Visual Analog Scale, the Rhodes Index of Nausea, Vomiting, and Retching, the Beck Anxiety Inventory, and the Functional Assessment of Cancer Therapy Scale-General (FACT-G) were used to collect research data. Within the scope of the research, IG received chemotherapy sessions for 10 weeks (five sessions) with 2-week intervals by an art specialist in marbling, accompanied by ney music. CG received no intervention. The obtained data were uploaded to the SPSS (22.0) program and statistical analysis was performed. Results: The decrease in the pain, nausea-vomiting, and anxiety levels of the patients in IG and the increase in their quality of life after the art therapy accompanied by ney music were statistically significant compared with the first follow-up (p < 0.05). There was no statistically significant change in the quality of life of the patients in the CG, whereas their pain, nausea-vomiting, and anxiety scores increased. According to the comparison between IG and CG, there was a significant difference in favor of IG in terms of pain severity, quality of life, emesis, and anxiety levels (p < 0.05). Conclusions: The art of marbling with ney was effective in operated breast cancer patients experiencing pain, emesis, and anxiety and improved their quality of life. Clinical Trial Registration: NCT05666583.