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Background: Chemotherapy-induced nausea and vomiting is a common problem in patients undergoing chemotherapy, influencing quality of life (QoL) and daily activities. This study will investigate whether therapists’ positive communication may strengthen positive treatment expectations and induce antiemetic effects during antiemetic treatment using standard care, sham acupuncture, or verum acupuncture, compared to neutral communication. It will also investigate whether a variety of patient, therapist and treatment components modify the treatment outcomes. Methods: This is a trial protocol for a randomized, sham-controlled, patient- and evaluator-blinded clinical trial. Patients (n = 198 patients according to a sample size calculation) with breast, colorectal, or bladder cancer undergoing neo-/adjuvant moderately to highly emetogenic chemotherapy are being randomized in 2 × 3 factorial design to the following conditions: 1. neutral or 2. positive communication style regarding expected treatment effects, during the antiemetic treatment types: A) standard care only (including antiemetics, no acupuncture), or, in addition to standard care, B) sham acupuncture with telescopic non-penetrating needles, or C) verum, penetrating acupuncture. The 2 communication styles 1 and 2 are carried out during the antiemetic treatments given by an intervention therapist immediately pre and post (20 minutes × 2) an intravenous chemotherapy session. Data are being collected at baseline on the day before the chemotherapy session, daily for 10 days, at a 10-day follow-up, and at a follow-up after completing the entire chemotherapy period, lasting about 6 months. Primary outcome is mean score Visual Analog Scale nausea grading for the first 5 days of the chemotherapy session period. Secondary outcomes are for example, vomiting, treatment expectations, QoL, daily and physical activity, and physiological measures. Treatment effect modifiers will be analyzed, for example, blinding success, treatment expectations, and previous nausea experiences. Conclusions: This trial will expand integrative cancer care’s understanding of the effects of communication for strengthening treatment expectations and thus alleviating chemotherapy-induced nausea and vomiting. If proven effective, the communication model of strengthening positive treatment expectations in patients with risk for nausea and vomiting can be implemented in routine clinical care as part of side-effect management for patients with cancer. Trial registration: US National Institutes of Health, https://clinicaltrials.gov/study/NCT03232541?term=NCT03232541&rank=1), # NCT03232541.

Background Nausea and vomiting are frequent complaints during pregnancy, which can be accompanied by marital discord and sexual dissatisfaction, in addition to the hospitalization of pregnant women. Given the potential side effects of pharmaceutical treatments on both the mother and fetus, many women prefer non-pharmacological interventions. This study will assess the impact of an educational program based on the Ottawa Nutritional Guide on symptoms in pregnant women and explore sexual satisfaction as a secondary outcome. Methods In this randomized controlled clinical trial, a total of 60 pregnant women aged between 15 and 45 years, who scored 3–16 on the Rhodes Index of Nausea, Vomiting and Retching (RINVR), will be selected via convenience sampling. They will be then divided into two intervention and control groups through block randomization. Data will be collected using a demographic and obstetric checklist, the RINVR, and the Hudson’s Index of Sexual Satisfaction (ISS). The intervention group will be received training on the Ottawa Nutritional Guide in two 60-min sessions, conducted in groups of two to five people. The control group, on the other hand, received routine care. The collected data will be analyzed using SPSS Version 22. Discussion Several studies have reported the effectiveness of the Ottawa Nutritional Guide in managing nausea and vomiting in pregnant women, as well as its positive impact on their quality of life and marital satisfaction. However, further research is required to validate these findings before considering it as a potential alternative to pharmaceutical methods during pregnancy. Trial registration This study was registered in the Iranian Registry of Clinical Trials (IRCT20180218038783N5, registered 03/09/2023). Plain English summary Nausea and vomiting are common issues that many pregnant women face, and these symptoms can also lead to relationship problems and dissatisfaction with sexual life. Since medical treatments can have risks for both mothers and their babies, many women prefer to explore non-drug options. Ottawa Nutritional Guide may help manage nausea and improve the quality of life and marital happiness for pregnant women.

Purpose Nausea and vomiting complicating chemotherapy (CINV) remain side effects despite preventive and curative treatments. We hypothesize that acupuncture (ACU), auriculotherapy (AUR), and their combination (ACU-AUR), could decrease, compared to usual treatment (UT), the intensity of acute nausea in patients already treated according to the antiemetic guidelines and presenting nausea with or without vomiting in the earlier cycle. Methods In this multicenter study, patients were treated just before chemotherapy according to randomization. ACU consisted of implanting bilaterally on each forearm, one semi-permanent needle at point P6. AUR consisted of implanting bilaterally on each pavilion of the ear, one semi-permanent needle at point O. All patients received systematic preventive drug treatment according to antiemetic guidelines. Main outcome was intensity of nausea at 24 h after chemotherapy using a numeric scale ranging from 0 (no nausea) to 10 (maximum symptoms). Results One hundred and fifteen patients were included. Baseline characteristics were similar between groups at inclusion. Intensity of nausea at 24 h after chemotherapy, was statistically different between the groups (covariance intergroup analysis, p  = 0.005) and was significantly lower for the all-treatment groups vs UT group ( p  = 0.007 for AUR, p  = 0.008 for ACU, and p  = 0.0009 for AUR-ACU). AUR-ACU also decreased intensity of delayed nausea when compared to UT ( p  = 0.023). AUR, ACU and AUR-ACU had no effect on acute and delayed vomiting episodes. No serious adverse event due to the studied treatments was reported in our study. Conclusion AUR or ACU reduce intensity of acute and delayed nausea in patients treated by optimal antiemetic treatment. Trial Registration Number. Clinicaltrials.gov identifier NCT02767791, registered on May 10, 2016.

To evaluate the safety and efficacy of aromatherapy on symptom burden and associated outcomes. 92 inpatients who underwent hematopoietic stem cell transplantation on hematology-oncology units in an academic hospital. Participants in this pilot randomized controlled trial received essential oil-infused or blank aromatherapy patches and completed a symptom journal. Mixed-model analysis of variance was used to analyze chemotherapy-induced nausea, vomiting, and retching (CINVR) and anxiety symptoms. A t test was used to analyze medications administered for CINVR. Descriptive statistics were used to analyze additional study aims. There was no significant difference in mean symptom scores or medications administered between the intervention and control groups. On a 1-10 rating scale (10 = extremely satisfied/extremely likely), aromatherapy was rated 8 or higher for satisfaction (n = 50) and likeliness to use again (n = 53). Aromatherapy can be used for holistic symptom management to improve the patient experience.

Background Auricular acupressure (AA) has been viewed as a promising approach to managing chemotherapy-induced nausea and vomiting (CINV) but relevant research evidence has been inconclusive. This study aimed to examine the effects of AA on CINV in breast cancer (BC) patients undergoing chemotherapy. Methods A preliminary randomized controlled trial was conducted in 114 BC patients. Participants were randomly allocated to a true AA group ( n  = 38), a sham AA group ( n  = 38), and a standard care group ( n  = 38). All the participants were provided with standard antiemetic treatment and care, while the true AA group and the sham AA group received an additional 5-day true AA and a 5-day sham AA, respectively. Acute and delayed CINV were assessed by using the MASCC Antiemesis Tool (MAT), anticipatory nausea and vomiting were measured by the Index of Nausea, Vomiting, and Retching (INVR), and patients’ quality of life (QoL) was evaluated by the Functional Assessment of Cancer Therapy-Breast (FACT-B). Results Both the true and sham AA groups reported improved CINV outcomes than the standard care group, with the true AA demonstrating larger effects than the sham comparison. The true and sham AA groups had higher complete response (CR) rates of CINV when compared with the standard care group, with the difference in the CR of acute CINV achieving statistical significance ( p  = 0.03). Both the true and sham AA groups demonstrated lower incidence and severity of acute CINV compared with the standard care group with the among-group difference reaching statistical significance for the occurrence ( p  = 0.04) and severity ( p  = 0.001) of acute nausea. No significant differences in anticipatory CINV and QoL were found among the groups. Conclusion The use of AA plus standard antiemetic treatment and care was superior to the use of standard antiemetic treatment and care alone in managing CINV among BC patients receiving chemotherapy. The antiemetic effects of AA were identified to be more profound in improving acute CINV, particularly acute nausea. The antiemetic effects of AA were deemed to be a mixture of specific treatment effects and placebo effects, and the placebo effects were very large and even reached clinical significance. Trial registration ClinicalTrials.gov; NCT02403037 ; Registered March 31, 2015.

Older adults are at high risk for toxicity due to cancer treatment and increased risk for adverse events related to chemotherapy-induced nausea and vomiting (CINV). Unfortunately, older adults report multiple treatment-related symptoms but use few strategies to self-manage these symptoms due to erroneous beliefs related to the effectiveness of commonly taught self-management strategies. We developed a novel serious game, Managing at Home (MAH), to help older adults learn how to effectively self-manage CINV at home. This study has 2 aims. Aim 1 is to examine changes in CINV severity, self-management behaviors, functioning, quality of life, cognitive representation, and health care use within the intervention group from baseline (T ) to completion of the study (T ). Aim 2 is to determine the efficacy of the MAH intervention by comparing differences in primary outcomes (CINV severity and health care use) and secondary outcomes (self-management behaviors, functioning, and quality of life) between the intervention and control groups at each follow-up visit (T -T ) and completion of the study (T ). This is a longitudinal randomized clinical trial. We will collect data from 500 older adults receiving cancer-related chemotherapy at baseline (T1) and at each treatment cycle until cycle 6 (T6). Participants will be enrolled if they are 60 years or older of age, are newly diagnosed with cancer, being treated with any chemotherapy agent with moderate or high emetic potential, are on a 2-, 3-, or 4-week treatment cycle, are proficient in English, and have a telephone. Previous diagnosis or treatment for cancer, end-stage disease with less than 6 months to live, and uncorrected visual or hearing impairment are exclusion criteria. This study was funded in September 2022 and received institutional review board approval in October 2022. As of July 2023, the enrollment of participants is ongoing and currently has 130 enrolled participants. Data collection and analysis will be complete in 2027. This study addresses self-management of CINV in older adults using an innovative serious game. The MAH intervention uses simulation and gaming technology to engage older adults in active learning in order to reframe erroneous perceptions about symptom self-management. If shown to be effective, it can easily be adapted to include other cancer-related symptoms or other chronic illnesses. ClinicalTrials.gov NCT05838638; https://clinicaltrials.gov/study/NCT05838638. DERR1-10.2196/64673.

To assess the efficacy of inhaled ginger aromatherapy on nausea, vomiting and health-related quality of life (HRQoL) in chemotherapy breast cancer patients. Single-blind, controlled, randomized cross-over study. Patients received 5-day aromatherapy treatment using either ginger essential oil or fragrance-matched artificial placebo (ginger fragrance oil) which was instilled in a necklace in an order dictated by the treatment group sequence. Two oncology clinics in the East Coast of Peninsular Malaysia. VAS nausea score, frequency of vomiting and HRQoL profile (EORTC QLQ-C30 scores). Sixty female patients completed the study (age=47.3±9.26 years; Malay=98.3%; on highly emetogenic chemotherapy=86.7%). The VAS nausea score was significantly lower after ginger essential oil inhalation compared to placebo during acute phase (P=0.040) but not sustained for overall treatment effect (treatment effect: F=1.82, P=0.183; time effect: F=43.98, P<0.001; treatment×time effect: F=2.04; P=0.102). Similarly, there was no significant effect of aromatherapy on vomiting [F(1, 58)=0.29, P=0.594]. However, a statistically significant change from baseline for global health status (P<0.001) was detected after ginger essential oil inhalation. A clinically relevant 10 points improvement on role functioning (P=0.002) and appetite loss (P<0.001) were also documented while patients were on ginger essential oil. At present time, the evidence derived from this study is not sufficiently convincing that inhaled ginger aromatherapy is an effective complementary therapy for CINV. The findings for HRQoL were however encouraging with significant improvement in several domains.

ObjectiveCancer treatment is a particularly stressful period for the patient. The reasons vary and include fear of treatment outcome as well as treatment induced side effects. The patient frequently experiences simultaneously various side effects resulting in a diminishing of the patient’s health-related quality of life (HRQoL). The study provides evidence on the co-occurrence and inter-relations between pain, anxiety, depression and fatigue in patients with breast and prostate cancer.DesignThis paper presents a secondary analysis of the data from a randomised control trial designed to test the effectiveness of guided imagery and progressive muscle relaxation on pain, fatigue, anxiety and depression. Non-parametric bootstrapping analyses were used to test the mediational model of anxiety, fatigue and depression as parallel mediators of the relationship between pain and HRQoL.SettingThe study was undertaken at the home setting.ParticipantsIn total 208 patients were included in the study (assigned equally in two groups), referred at the outpatient clinics of the three participating cancer care centres.ResultsThe three mediators fully mediate the relationship between pain and HRQoL indirect effect (IEoverall=−0.3839, 95% CI: lower limit (LL)=−0.5073 to upper limit (UL)=−0.2825) indicating that patients with increased pain are likely to have higher levels of anxiety, fatigue and depression. Gender significantly moderated the mediational effect of Fatigue Index of Moderated Mediation (IMM=−0.2867 SE=0.1526, LL=−0.6127, UL=−0.0226) but did not moderate mediational effect of anxiety (IMM=−0.0709, SE=0.1414, LL=−0.3459, UL=+0.2089). The results show that the three mediators in a serial causal order fully mediate the relationship between pain and HRQoL (IEoverall=−0.384, 95% CI: LL=−0.51 to UL=−0.284) and the ratio of the overall indirect effect to the total effect is 0.8315 (95% CI: LL=0.5683 to UL=1.1718).ConclusionThis work provides evidence that targeting fatigue, anxiety and depression may have a meaningful effect on pain as a related symptom and potentially have a positive impact on HRQoL of patients with breast and prostate cancerTrial registration number NCT01275872; Post-results.

Abstract Objective Chemotherapy-induced nausea and vomiting (CINV) is an adverse outcome associated with chemotherapy and is sometimes difficult to manage. This study aimed to examine the impact of a single session of transcranial direct current brain stimulation (tDCS; 2 mA) over the motor cortex for 20 minutes before chemotherapy in patients receiving a highly emetogenic chemotherapy. Study Design Prospective randomized double-blind sham-controlled study. Setting Academic medical center. Method Sixty patients with breast cancer who were scheduled for chemotherapy treatment were selected and allocated randomly into two equal groups: a stimulation group and a sham group. tDCS was implemented over the primary motor area (M1) (2 mA) for 20 minutes. Patients’ nausea was measured by a cumulative index of nausea, a visual analog scale for nausea (VAS-N), episodes of vomiting, and the Edmonton Symptoms Assessment Scale (ESAS) to assess symptoms like pain, malaise, and sense of well-being. Evaluation was done before stimulation and every 24 hours for 72 hours after the end of infusion of chemotherapy. Results The tDCS group showed a reduction in the cumulative index of nausea (P < 0.001, F = 50), the VAS-N (P < 0.001, F = 52), the ESAS malaise score (P < 0.001, F = 37.6), and the sense of well-being score (P < 0.001, F = 25) vs the sham group. Six patients (20%) in the tDCS group required rescue antiemtic therapy vs 14 patients (46.7%) in the sham group (P < 0.028). Conclusion A single session of M1 tDCS is suggested as an effective adjuvant therapy to control CINV in female patients suffering from breast cancer and receiving highly emetogenic chemotherapy. Corroboratory studies are needed.

In this proof-of-concept study, we tested whether placebo effects can be monitored and predicted by plasma proteins. In a randomized controlled design, 90 participants were exposed to a nauseating stimulus on two separate days and were randomly allocated to placebo treatment or no treatment on the second day. Significant placebo effects on nausea, motion sickness, and (in females) gastric activity could be verified. Using label-free tandem mass spectrometry, 74 differentially regulated proteins were identified as correlates of the placebo effect. Gene ontology (GO) enrichment analyses identified acute-phase proteins and microinflammatory proteins to be involved, and the identified GO signatures predicted day-adjusted scores of nausea indices in the placebo group. We also performed GO enrichment analyses of specific plasma proteins predictable by the experimental factors or their interactions and identified 'grooming behavior' as a prominent hit. Finally, Receiver Operator Characteristics (ROC) allowed to identify plasma proteins differentiating placebo responders from non-responders, comprising immunoglobulins and proteins involved in oxidation reduction processes and complement activation. Plasma proteomics is a promising tool to identify molecular correlates and predictors of the placebo effect in humans.