A randomized controlled trial of hand/foot-cooling by hilotherapy to prevent oxaliplatin-related peripheral neuropathy in patients with malignancies of the digestive system.

BACKGROUND: Both acute and chronic symptoms of oxaliplatin-induced peripheral neuropathy (OIPN) affect patients' treatment dose and duration as well as quality-of-life. Hand/foot-cooling has been shown to reduce taxane-induced peripheral neuropathy but there is unclear evidence in the setting of oxaliplatin. PATIENTS AND METHODS: In a monocentric, open-label phase II trial, patients with malignancies of the digestive system receiving oxaliplatin-based chemotherapy were randomly assigned to receive either continuous cooling of hands and feet using hilotherapy at 11°C during oxaliplatin infusion compared with usual care (no cooling). The primary endpoint was grade ≥2 neuropathy-free rate in 12 weeks after initiation of chemotherapy. Secondary endpoints included OIPN-related treatment alterations, acute OIPN symptoms and perceived comfort of the intervention. RESULTS: The intention-to-treat population included 39 patients in the hilotherapy group and 38 in the control group. The grade ≥2 neuropathy-free rate at 12 weeks was 100% in the experimental group versus 80.5% in the control group (P = 0.006). This effect was persistent at 24 weeks (66.0% versus 49.2%, respectively) (P = 0.039). Next, treatment alterations-free rate at week 12 was 93.5% in the hilotherapy group compared with 83.3% in the control group (P = 0.131). Patients in the hilotherapy group experienced significantly less acute OIPN symptoms of numbness or tingling [odds ratio (OR) 0.05, 95% confidence interval (CI) 0.02-0.11, P < 0.0001], pain (OR 0.06, 95% CI 0.02-0.15, P < 0.0001) and/or cold sensitivity (OR 0.02, 95% CI 0.01-0.05, P < 0.0001) in fingers or toes as well as less pharyngeal cold sensitivity (OR 0.14, 95% CI 0.05-0.42, P = 0.0005). The majority of patients in the hilotherapy group rated the intervention as neutral, rather comfortable or very comfortable. CONCLUSIONS: In this first study on hand/foot-cooling in oxaliplatin alone, hilotherapy significantly reduced the incidence of grade ≥2 OIPN at 12 and 24 weeks. Hilotherapy also reduced acute OIPN symptoms and was generally well tolerated.

Scalp cooling in breast cancer patients treated with docetaxel-cyclophosphamide: patient- and nurse-reported results.

PURPOSE: Recent evidence supports the efficacy of scalp cooling in preventing chemotherapy-induced alopecia in breast cancer treatments. However, efficacy largely varies between treatment regimens. The aim of this study was to explore the patient- and nurse-reported results of scalp cooling in terms of hair loss and need for a wig/head cover in patients with breast cancer treated with 3-weekly docetaxel 75 mg/m2- cyclophosphamide 600 mg/m2. METHODS: We studied nurse-reported efficacy as noted in the electronic patient files of 85 patients treated with docetaxel 75 mg/m2- cyclophosphamide 600 mg/m2 between 1/1/2017 and 1/1/2020. Sixty-nine of them also self-reported on their scalp cooling results up to one year after adjuvant chemotherapy in a retrospective way. RESULTS: Nurse- and patient-reported data showed that scalp cooling was successful (i.e., hair loss < 50%) in 47.1 and 44.9% of patients, respectively, and 55% of patients were (very) satisfied with the result of scalp cooling. Scalp cooling was perceived as (very) uncomfortable in 36.2% of patients. Regarding hair status one year after treatment, 47 patients (55.3%) reported no changes compared to their hair status before treatment. CONCLUSIONS: Scalp cooling is successful in preventing severe chemotherapy-induced alopecia in almost half of the patients with breast cancer treated with docetaxel 75 mg/m2- cyclophosphamide 600 mg/m2. Better understanding of the success rate of scalp cooling enables correct patient information and decision-making support.

The use of patient reported outcome measures (PROMs) in palliative radiotherapy: A topical review.

Radiotherapy (RT) can be used to palliate cancer-related symptoms and improve quality of life (QoL). Patient Reported Outcome Measures (PROMs) could be a reliable, minimally invasive method to monitor patients after palliative radiotherapy. This review was performed to provide an overview of the way PROMs are currently used in follow-up after palliative RT, regarding the goal of the PROM, the type of PROMs, PROM selection, PROM completion as well as the follow-up schemes and patient adherence and attrition. Pubmed, EMBASE and the Cochrane Library were systematically searched for articles published between 2008 and 2020. Titles and abstracts were reviewed to find relevant studies, which were advanced to full-text review. The reference lists of review articles were screened for correctness of the search and additional studies. No meta-analysis was performed. This search strategy identified 5733 studies, with 94 ultimately selected for inclusion in this topical review. We discovered a great variety of studies that used PROMs after palliative RT. We found no articles describing PROMs in routine clinical care. PROMs were exclusively used as a benchmarking tool and never to improve symptom control or QoL for individual patients. The selection process for the questionnaires, completion method and/or follow-up scheme was seldom described. We did not find any studies referencing patients' experience on PROMs. Although clear guidelines on the use of PROMs in palliative RT may be difficult to establish, more attention should be paid to the PROM aspect when writing study protocols. Furthermore, efforts should be made to introduce PROMs in routine clinical care in the context of palliative RT.

The effect of adjuvant chemotherapy on symptom burden and quality of life over time; a preliminary prospective observational study using individual data of patients aged ≥70 with early stage invasive breast cancer.

OBJECTIVES: We aim to assess short and long term effects of chemotherapy on patient-reported quality of life (QOL) and patient versus clinician symptom reporting in older patients with breast cancer adjusted for tumour and aging parameters. MATERIAL AND METHODS: In this prospective, multicentre, non-interventional, observational study, women aged ≥70years were enrolled after surgery and assigned to a TC chemotherapy (docetaxel and cyclophosphamide) group or a control group depending on their planned adjuvant treatment. Longitudinal multivariate models were used to assess the statistical and minimal clinically important difference (MCID) in the impact of TC chemotherapy over time on QOL and symptom burden adjusted for baseline aging and tumour parameters. Statistical significance was set at 5% and MCID at 10 points. RESULTS: In total, 57 patients were enrolled in the chemotherapy and 52 patients in the control group. Within the chemotherapy group, clinical deterioration was reported at 3months for Fatigue (17.73), Dyspnoea (17.05), Diarrhoea (12.06) and Appetite Loss (17.05) scores (all p<0.001). However, the scores had returned to baseline (or even better for Role Functioning) at year 1. No clinical deterioration was reported in the control group. Symptom scores as reported by patients were significantly (p<0.05) higher than those reported by the clinicians, even more so for Fatigue, Dyspnoea, and Pain. CONCLUSION: Our results show that symptom burden and diminished QOL in an older breast cancer population receiving adjuvant TC chemotherapy are short-lived and disappear after a while with no long-term differences compared to a similar population not receiving chemotherapy.

Dealing with chemotherapy-related symptoms at home: a qualitative study in adult patients with cancer.

Given that chemotherapy treatments are done mostly in an outpatient setting, patients with cancer must deal with treatment-related symptoms mainly at home. Evidence suggests that they often feel left alone or unprepared to do so. This qualitative study explores how patients deal with chemotherapy-related symptoms in their home, which factors and ideas influence their self-management and what role professional caregivers play. One-off, semi-structured interviews were held with 28 adult patients with cancer being treated with chemotherapy. Using a Grounded Theory approach, we cyclically collected and analysed data to come to a thorough understanding of the major conceptual themes and their interconnections. Dealing with chemotherapy-related symptoms involves a process of experiencing and learning how side effects unfold over time and how to deal with them. Patients express very personal symptom experiences and symptom-management styles, which are shaped by personal factors (e.g. coping with cancer and cancer treatment, perceived level of control) and environmental factors (e.g. professionals' attitude, information resources). Improving symptom self-management support requires active exploration of the personal symptom experience and symptom-management style. Professional care should be tailored to the patient's perspective and should address personal and environmental determinants of their behaviour.