Cancer therapy-related vaginal toxicity: its prevalence and assessment methods-a systematic review.

PURPOSE: In 2020, almost 9 million women were diagnosed with cancer worldwide. Despite advancements in cancer treatment strategies, patients still suffer from acute and long-term side effects. This systematic review aims to evaluate the most frequently reported adverse effects in the genitourinary system and compare them across cancer types, treatment modalities, and evaluation methods. METHODS: Pubmed Central, SCOPUS, and Cochrane Library were searched following the PRISMA guidelines to identify all prospective and retrospective observational cohort studies and randomized controlled trials assessing vaginal side effects of adult female cancer patients. The study quality was evaluated using The Newcastle-Ottawa Scale or the Risk of Bias 2 tool, as appropriate. RESULTS: The most prevalent population was breast cancer patients, followed by gynaecological cancer patients. Overall, the focus was on vaginal dryness, while vaginal stenosis was the primary outcome in gynaecological cancer patients. Significant discrepancies were found in the frequency and severity of the reported adverse events. Most studies in this review evaluated side effects using patient-reported outcome measures (PROMs). CONCLUSIONS: Genitourinary syndrome of menopause following cancer treatment is most frequently documented in breast and gynaecological cancer patients, often focussing on vaginal dryness and vaginal stenosis based on PROMs. This review provides a complete overview of the literature, but more high-quality clinical trials are necessary to draw firm conclusions on acute and chronic vaginal toxicity following cancer treatment. IMPLICATIONS FOR CANCER SURVIVORS: This review could help improve the current preventive and curative management options for genitourinary complications, thereby increasing the patient's QoL and sexual functioning.

A novel, multi-active emollient for the prevention of acute radiation dermatitis in breast cancer patients: a randomized clinical trial.

PURPOSE: To investigate the efficacy of a novel, multi-active emollient in preventing and managing acute radiation dermatitis (ARD) in breast cancer patients undergoing moderate hypofractionated (HF) radiotherapy (RT) compared to standard of care. METHODSA: A monocentric, open-label, randomized clinical trial (RCT) with breast cancer patients receiving moderate HF (dose: 40.05-55.86 Gy, fractions: 15-21) was conducted between January 2022 and May 2023. The experimental group received the novel emollient, while the control group received the standard skin care. Patients applied the skin care products twice daily during the complete RT course. The primary outcome was the severity of ARD at the final RT session measured by the modified Radiation Therapy Oncology Group (RTOG) criteria. Secondary outcomes included patient symptoms, quality of life (QoL), and treatment satisfaction. RESULTS: A total of 100 patients with 50 patients per group were enrolled. In the control group, 50% of the patients developed RTOG grade 1 ARD and 48% grade 2 or higher, while in the experimental group, the severity of ARD was significantly lower with 82% grade 1 and 16% grade 2 ARD (P = .013, χ2-test). The frequency and severity of xerosis were significantly lower in the experimental compared to the control group (Ps ≤ .036, Mann Whiney U test). The impact of ARD on the QoL was low, and treatment satisfaction was high in both groups, with no significant difference. CONCLUSION: This RCT shows that the novel, multi-active emollient significantly reduced the ARD RTOG grade. Research in a more diverse patient population is warranted. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04929808 (11/06/2021).

Patient-Centred Outcomes after Totally Endoscopic Cardiac Surgery: One-Year Follow-Up.

Patient-centred outcomes have grown in popularity over recent years in surgical care research. These patient-centred outcomes can be measured through the health-related quality of life (HRQL) without professional interpretations. In May 2022, a study regarding patient-centred outcomes up to 90 days postoperatively was published. Fourteen days after surgery, the HRQL decreased and returned to baseline levels after 30 days. Next, the HRQL significantly improved 90 days postoperatively. However, this study only focuses on a short-term follow-up of the patients. Hence, this follow-up study aims to assess the HRQL one year after totally endoscopic cardiac surgery. At baseline, 14, 30, and 90 days, and one year after surgery, the HRQL was evaluated using a 36-item short form and 5-dimensional European QoL questionnaires (EQ-5D). Using the 36-item short form questionnaire, a physical and mental component score is calculated. Over the period of one year, this physical and mental component score and the EQ-5D index value significantly improve. According to the visual analogue scale of the EQ-5D, patients score their health significantly higher one year postoperatively. In conclusion, after endoscopic cardiac surgery, the HRQL is significantly improved 90 days postoperatively and remains high one year afterward.

The use of photobiomodulation therapy for the management of chemotherapy-induced alopecia: a randomized, controlled trial (HAIRLASER trial).

PURPOSE: The purpose of this trial was to evaluate if photobiomodulation (PBM) can accelerate hair regrowth after chemotherapy in breast cancer patients and if this is correlated with a better quality of life (QoL). METHODS: A randomized controlled trial with breast cancer patients that underwent an anthracycline and taxane-containing chemotherapy regimen was set up at the Jessa Hospital (Hasselt, Belgium). Patients were randomized into the control group (no intervention) or the PBM group (three PBM sessions each week for 12 weeks, starting the last day of their chemotherapy). Hair regrowth was evaluated based on photographic assessments. Two blinded researchers independently scored the hair regrowth using a numerical rating scale (NRS). In addition, the QoL was measured using the European Organization for Research and Treatment-QOL questionnaire and Breast Cancer-specific module (EORTC QLQ-C30 and QLQ-BR23). Data were collected on the day of their last chemotherapy session and 1, 2, and 3 months post-chemotherapy. RESULTS: A total of 32 breast cancer patients were included in the trial between June 2020 and February 2022. Significantly higher NRS scores were observed in the PBM group at 1-month post-chemotherapy compared to baseline, whereas they remained constant in the control group. Patients allocated to the PBM group scored their global health significantly higher at all time points compared to the control. CONCLUSION: Based on the results of the HAIRLASER trial, PBM seems to accelerate hair regrowth after chemotherapy in breast cancer patients resulting in an improved global health status and better body image. The study was registered in July 2019 at ClinicalTrials.gov (NCT04036994).

Evaluation of a novel skin care product for the management of chemotherapy-related dermatologic toxicities: A quasi-experimental study.

PURPOSE: Evaluate the efficacy of a novel skincare product for the management of chemotherapy-related dermatological toxicities. METHODS: A monocentric, prospective, interventional, open-label, pretest-posttest, single-group study with cancer patients receiving chemotherapy (n = 100) was set up. All enrolled patients applied the emollient daily to their face and body for three weeks. The severity of the skin reactions was evaluated by a researcher using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 at baseline and end of the trial. Patient-reported outcomes (PROs) included the frequency and severity of skin symptoms (Numerical rating scale, NRS), quality of life (QoL; Skindex-16 and Dermatology Life Quality Index), Patient Benefit Index (PBI), and treatment satisfaction. PROs were collected at baseline, weekly, and at the end of the trial. RESULTS: According to the CTCAE and NRS, the novel emollient significantly improved the severity and frequency of xerosis and pruritus (Ps ≤ .001). A significant reduction in the NRS score for frequency of erythema was measured (p < .001). The frequency and severity of burning and pain did not change. Regarding the patients' QoL, no beneficial effect of the skin care product was measurable. 44% of the patients experienced at least one patient-relevant treatment benefit. 87% of the patients were satisfied with the emollient and would recommend it. CONCLUSIONS: This study shows that the novel emollient significantly reduced chemotherapy-induced skin toxicity, more specifically xerosis and pruritus without hampering patient's QoL. Future research is needed to make definite conclusions using a study design including a control group and a long-term follow-up.

A long-term follow-up of early breast cancer patients treated with photobiomodulation during conventional fractionation radiotherapy in the prevention of acute radiation dermatitis.

OBJECTIVES: The evidence demonstrating the efficacy of photobiomodulation (PBM) therapy for preventing and managing acute radiation dermatitis (ARD) is growing steadily. The question that arises from many clinicians is, if PBM is safe for oncologic patients. This study aimed to evaluate the disease-free survival (DFS), cancer-free survival (CFS), and overall survival (OS) of breast cancer patients treated with PBM for ARD. METHODS: Clinical data of 120 breast cancer patients treated with prophylactic PBM (n = 60, 2x/week, 808-905 nm, 4 J/cm2 ) or placebo (n = 60) during conventional fractionation (CF) radiotherapy (RT) between April 2015 and June 2017 were retrospectively analyzed (TRANSDERMIS trial). During follow-up (April 2015 to May 2022), patients underwent a complete clinical evaluation every 6 months and blood analysis and mammography yearly in the first 5 years after the end of RT. The DFS, CFS, and OS were estimated. RESULTS: At a median follow-up time of 66 months (range 4-81), there was no significant difference in DFS (73.7% vs. 98.3%, resp., p = 0.54), CFS (68.4% vs. 77.8%, resp., p = 0.79), and OS (87.9% vs. 98.3%, resp., p = 0.30) between the placebo and PBM group. CONCLUSIONS: This paper is the first to describe the results of a long-term follow-up in early-stage breast cancer patients who underwent PBM for ARD. Results suggest that using PBM in breast cancer patients undergoing CF RT does not influence the locoregional recurrence, the development of new primary tumors, or OS.

90-Day Patient-Centered Outcomes after Totally Endoscopic Cardiac Surgery: A Prospective Cohort Study.

Over the past years, minimally invasive procedures have been developed to reduce surgical trauma after cardiac surgery. The value of patient-centered outcomes, including the quality of recovery after hospital discharge, is increasingly recognized. Identifying meaningful changes in postoperative function that might have a negative impact on patients without noticeable complications can provide a more comprehensive understanding of the impact on the patient's life. In total, 209 patients were included in this trial. Of these, 193 patients underwent totally endoscopic cardiac surgery, 8 underwent cardiac surgery through a sternotomy, and 8 underwent transcatheter aortic valve implantation. Patients who previously underwent cardiac surgery were excluded. Quality of life was determined through the Short Form 36 and European Quality of Life-5 Dimensions questionnaires before the surgery and 14, 30, and 90 days afterward. In patients who underwent totally endoscopic cardiac surgery, the quality of life improved over the three time periods. The different domains of the questionnaire evolved in a positive manner. However, 14 days postoperatively, a decline in quality of life was noted, followed by a return to baseline at 30 days and an increase at 90 days. In conclusion, totally endoscopic cardiac surgery improves the quality of life 90 days after surgery.