Dataset Information

External application of liver compresses to reduce fatigue in patients with metastatic cancer undergoing radiation therapy, a randomized clinical trial.

ABSTRACT:

Background

Liver compresses are frequently used in integrative medicine as supportive therapy during cancer treatment in order to reduce fatigue. We performed a pilot study to test whether the external application of yarrow liver compresses impacts fatigue in patients with metastatic cancer undergoing radiation therapy.

Methods

A randomized prospective pilot trial was performed including patients with brain metastasis or bone metastasis of solid tumors. Patients underwent either palliative radiation therapy (RT) of the metastatic lesions (control group) over two weeks or the same RT with additional external application of yarrow liver compresses once daily during RT. The primary objective was improvement on the general fatigue subscale of the multidimensional fatigue inventory (MFI-20) at the end of treatment, where a mean difference of two points is considered clinically relevant. Secondary objectives included psychological distress, quality of life and qualitative analysis with self-established visual analogue scales (VAS). Mean differences in general fatigue at the end of treatment compared to baseline were analyzed using the ANCOVA test.

Results

From 09/2017 to 08/2019 a total of 39 patients were randomized. Due to drop outs 24 patients (12 per group) were available for analysis. Patients in the intervention group received a mean number of 10.5 (range, 7-14) applications of yarrow liver compresses. The mean improvement at the end of therapy on the general fatigue subscale of the MFI-20 was 2 points in favor of the intervention group (p = 0.13), and all other MFI-20 subscales showed at least a trend towards improvement in favor of the intervention group. Likewise, psychological distress and VAS data was improved, the latter reaching statistical significance for the symptoms fatigue, tension and lack of drive. Major toxicities were not observed.

Conclusions

External application of liver compresses appears to reduce fatigue within a clinical relevant range in patients with metastatic cancer undergoing radiation therapy.

Trial registration

ISRCTN, ICTRP DRKS00012999.

SUBMITTER: Ghadjar P

PROVIDER: S-EPMC8054395 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundIn metastatic colorectal cancer (CRCm), fatigue is pervasive, reduces quality of life, and is negatively associated with survival. Its course is explained in part by psychosocial variables such as emotional distress, coping strategies, or perceived control. Thus, to reduce fatigue, psychosocial interventions appear to be relevant. In some cancers, Cognitive Behavioral Therapies (CBT) reduce fatigue. Hypnosis is also used as a complementary therapy to reduce the side effects of cancer. While CBT requires specific training often reserved for psychologists, hypnosis has the advantage of being increasingly practiced by caregivers and is therefore less expensive (Montgomery et al., 2007). On the other hand, CBT and hypnosis remain understudied in the CRC, do not focus on the symptom of fatigue and in Europe such programs have never been evaluated.ObjectivesImplementing an intervention in a healthcare setting is complex (e.g., economic and practical aspects) and recruiting participants can be challenging. The primary objective will therefore be to study the feasibility of two standardized interventions (hypnosis and CBT) that aim to reduce fatigue in patients with CRCm treated in a French cancer center.Methods and designA prospective, single-center, randomized interventional feasibility study, using mixed methods (both quantitative and qualitative). A total of 60 patients will be allocated to each intervention group [Hypnosis (n = 30) and CBT (n = 30)]. Participants will be randomized into two parallel groups (ratio 1:1). Both programs will consist of 6 weekly sessions focusing on the CRF management over a period of 6 weeks. Trained therapists will conduct the program combining 3 face-to-face sessions and 3 online sessions. The feasibility and experience of interventions will be evaluated by the outcome variables, including the adhesion rate, the reasons for acceptability, relevance or non-adherence, the satisfaction, the fatigue evolution (with ecological momentary assessments), and the quality of life. All questionnaires will be self-assessment using an online application from the cancer center.DiscussionResults will highlight the barriers/facilitators to the implementation of the program and the relevance of the program to the patients, and will be used to generate hypotheses for a randomized control trial.Clinical trial registrationClinicalTrials.gov Identifier: NCT04999306; https://clinicaltrials.gov/ct2/show/NCT04999306.

Project description:Procedural anxiety is a concern for a number of patients undergoing radiation therapy. While procedural anxiety is often treated pharmacologically, there is a clinical need for effective alternative strategies for patients who are contraindicated from medication use, and those who prefer not to take unnecessary medications.ObjectivesThe primary objective was to assess the efficacy of nonpharmacological interventions delivered to adults with cancer, in the radiation oncology department, just prior to, or during radiation therapy, in reducing levels of self-reported procedural anxiety. The secondary objectives were to assess the efficacy of these interventions in reducing physiological symptoms of procedural anxiety and anxiety-related treatment disruptions.DesignSystematic review.Data sourcesElectronic databases (MEDLINE, CINAHL, EMBASE, PsycINFO and Cochrane Central Register of Controlled Trials) were searched from inception up until February 2022.Inclusion criteriaPopulation: Adult patients with cancer undergoing external beam radiation therapy.InterventionNonpharmacological interventions delivered within the radiation therapy department. Comparison: standard care controls, or standard care plus an alternative intervention.Outcomeslevel of self-reported procedural anxiety (primary), physiological symptoms of anxiety (secondary) and measures of anxiety-related treatment disruptions (secondary).Data extraction and analysisTwo reviewers independently extracted data. A meta-analysis was originally planned but deemed not feasible as the studies could not be confidently pooled for meta-analysis, due to the variability in the interventions, study designs and the generally low number of studies. Therefore, a narrative synthesis is presented.ResultsScreening of 2363 records identified nine studies that met inclusion criteria: six studies of music interventions, two of video-based patient education and one of aromatherapy. Overall, three studies received a global rating of strong methodological quality and low risk of bias. Three studies reported a significant effect of the intervention on reducing the primary outcome of self-reported procedural anxiety: two music interventions (both strong methodological quality), and one video-based patient education (moderate methodological quality). One of the studies (a music intervention) also reported a significant reduction in the secondary outcome of physiological symptoms of procedural anxiety (systolic blood pressure).ConclusionsThe evidence for nonpharmacological interventions delivered to adults with cancer just prior to, or during radiation therapy, in reducing levels of self-reported procedural anxiety is limited, with very few well-designed studies. There is a need for interventions for procedural anxiety during radiation therapy to be evaluated through rigorous randomised controlled trials.

Project description:IntroductionThe aim of this study is to conduct a meta-analysis to assess the efficacy of yttrium-90 selective internal radiation therapy (SIRT) in treating patients with breast cancer with hepatic metastasis.MethodPubMed and The Cochrane Library were queried from establishment to January 2021. The following keywords were implemented: "breast", "yttrium", and "radioembolization". The following variables and outcomes were collected: publication year, region, sample size, study design, presence of extrahepatic disease, tumor burden, infused radioactivity, breast cancer subtype, previous treatment, median survival time (MST), length of follow-up, adverse events, and radiographical response such as Response Evaluation Criteria in Solid Tumors (RECIST), modified RECIST (mRECIST), and Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST).ResultsA total of 24 studies from 14 institutions were included in the present meta-analysis. On the basis of the data from 412 patients, post-embolization MST was 9.8 [95% confidence interval (CI): 9.0-11.6] months. Patients with additional extrahepatic metastasis had a poorer survival rate compared with those with localized hepatic metastasis only (MST: 5.3 vs. 15 months, p < 0.0001). Patients with <25% liver tumor burden exhibited more promising survival than those with >25% (MST: 10.5 vs. 6.8 months, p < 0.0139). On the basis of RECIST, mRECIST, and PERCIST criteria, tumor response rate was 36% (95% CI: 26%-47%), 49% (95% CI: 34%-65%), and 47% (95% CI: 17%-78%), respectively, whereas tumor control rate was 85% (95% CI: 76%-93%), 73% (95% CI: 59%-85%), and 97% (95% CI: 91%-100%), respectively.ConclusionOn the basis of the available published evidence, SIRT is feasible and effective in treating patients with breast cancer with liver metastasis. Patients with lower hepatic tumor burden and without extrahepatic metastasis demonstrated more survival benefit. Future randomized controlled trials are warranted.