Marithé Claes

The online version contains supplementary material available at 10.1007/s10103-026-04852-1.

Objective: Immunotherapy can be accompanied by cutaneous adverse events that negatively impact the patient's quality of life (QoL). This trial aimed to evaluate the efficacy of two novel skin care products in preventing and managing cutaneous adverse events associated with immunotherapy.

Purpose Chemotherapy-induced alopecia (CIA) is a prominent side effect of chemotherapy, negatively impacting the patient’s body image and self-confidence. Scalp cooling (SC) has emerged as a preventive option for CIA, but the success rate and adherence vary. Research shows that photobiomodulation (PBM) can improve hair growth by stimulating cell proliferation and repair processes. This trial aims to evaluate the effectiveness of PBM combined with SC in preventing CIA. Methods A randomized, controlled trial with 29 breast cancer patients undergoing taxane-based chemotherapy was performed at the Jessa Hospital (Belgium). Patients were randomized into the control (n = 16) or the intervention group (n = 13). Blinded researchers evaluated scalp coverage and hair thickness, while questionnaires were administered to assess scalp coverage, satisfaction, and health-related quality of life (HRQL). The trial was registered at clinicaltrials.gov (NCT05177289, 4th of January 2022). Results The scalp coverage and hair thickness did not differ significantly between the two groups. Patients in the PBM group scored higher on global health (P = 0.043), physical functioning (P = 0.039), role functioning (P = 0.049), and social functioning (P = 0.038). Patients receiving a paclitaxel-based chemotherapy showed less hair loss compared to patients undergoing a docetaxel-based regimen (Ps < 0.001). No differences in SC adherence could be observed between the two groups. Conclusions The addition of PBM to SC did not increase its efficacy in preventing hair loss during chemotherapy. Patients in the PBM group did score their HRQL higher compared to the control group. Further research is required to establish the use of PBM in CIA prevention and to corroborate these findings.

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.

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 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.

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.

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.