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Preliminary Efficacy and Safety of Reishi & Privet Formula on Quality of Life Among Non-Small Cell Lung Cancer Patients Undergoing Chemotherapy: A Randomized Placebo-Controlled Trial.

ABSTRACT: BACKGROUND:Cancer patients often experience decreased quality of life during chemotherapy. This study aimed to determine the preliminary efficacy and safety of Reishi & Privet Formula (RPF) for maintaining quality of life among patients with non-small cell lung cancer (NSCLC) undergoing chemotherapy. METHODS:We conducted a phase II randomized, double-blind, placebo-controlled clinical trial in China. Adults with NSCLC scheduled to receive chemotherapy were randomly assigned (3:1 ratio) to receive oral RPF (3.36 g/day) or placebo daily for 6 weeks. The main outcome was the Functional Assessment of Cancer Therapy-Lung (FACT-L). We evaluated RPF's safety profile using the Common Terminology Criteria for Adverse Events and assessed changes in outcome measures from baseline to weeks 3 and 6 using a linear mixed effects model. RESULTS:We enrolled 82 participants across 8 cancer centers in China. The median age was 59 years, 56 (68%) had advanced cancer. Compared with the placebo group, the RPF group had nonstatistically significant higher quality of life as measured by the FACT-L total score (P = .086) over 2 cycles of chemotherapy. The RPF group was associated with a nonsignificant better general health (P = .050) and emotional well-being (P = .090) than the placebo group. Adverse events rates did not differ between groups. CONCLUSIONS:This study demonstrated preliminary safety and suggests a promising trend in RPF's effect on maintaining quality of life and emotional well-being among NSCLC patients undergoing chemotherapy. Future adequately powered randomized-controlled trials are needed to verify the efficacy and safety of RPF in cancer patients undergoing chemotherapy.

SUBMITTER: Liu J

PROVIDER: S-EPMC7450289 | biostudies-literature | 2020 Jan-Dec

REPOSITORIES: biostudies-literature

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Preliminary Efficacy and Safety of Reishi & Privet Formula on Quality of Life Among Non-Small Cell Lung Cancer Patients Undergoing Chemotherapy: A Randomized Placebo-Controlled Trial.

Liu Jie J Mao Jun J JJ Li Susan Qing SQ Lin Hongsheng H

Integrative cancer therapies 20200101

<h4>Background</h4>Cancer patients often experience decreased quality of life during chemotherapy. This study aimed to determine the preliminary efficacy and safety of Reishi & Privet Formula (RPF) for maintaining quality of life among patients with non-small cell lung cancer (NSCLC) undergoing chemotherapy.<h4>Methods</h4>We conducted a phase II randomized, double-blind, placebo-controlled clinical trial in China. Adults with NSCLC scheduled to receive chemotherapy were randomly assigned (3:1 r ...[more]

PMID: 32840126

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Project description:IntroductionThe best treatment therapy for gastrointestinal cancer patients is assessed by the improvement of health status and quality of life (QoL) after treatments. Malnutrition is related to loss of muscle strengths which leads to lower physical performance and emotional status. Thus, this study aimed to estimate the effects of nutritional interventions on the improvement of QoL among gastrointestinal patients undergoing chemotherapy in Vietnam.MethodsA quasi-experiment with intervention and control groups for pre- and post-intervention assessment was carried out at the Department of Oncology and Palliative Care-Hanoi Medical University Hospital from 2016 to 2019. Sixty gastrointestinal cancer patients were recruited in each group. The intervention regimen consisted of nutritional counseling, a specific menu with a recommended amount of energy, protein, and formula milk used within 2 months. Nutritional status and QoL of patients were evaluated using The Scored Patient-Generated Subjective Global Assessment (PG-SGA) and The European Organization for Research and Treatment of Cancer (EORTC). The difference in differences (DiD) method was utilized to estimate the outcome between control and intervention groups.ResultsAfter the intervention, patients of the intervention group had better changes in scores of global health status (Coef =16.68; 95% CI =7.90; 25.46), physical (Coef =14.51; 95% CI =5.34; 23.70), and role functioning (Coef =14.67; 95% CI =1.63; 27.70) compared to the control group. Regarding symptom scales, the level of fatigue, pain, and insomnia symptoms significantly reduced between pre- and post-intervention in the intervention group. In addition, living in urban areas, defined as malnourished and having low prealbumin levels, were positively associated with the lower global health status/QoL score.ConclusionNutritional therapy with high protein was beneficial to the improvement in QoL, physical function and the reduction of negative symptoms among gastrointestinal cancer patients. Early individualized nutritional support in consultation with professional dietitians during chemotherapy plays an integral part in enhancing the QoL and better treatment prognosis.Clinical trial registration numberNCT04517708.

Project description:BackgroundChemotherapy is associated with a wide range of physical and psychological side effects, so complementary and alternative therapies may be practiced as an independent treatment or combined with the standard ones to improve health-related quality of life of cancer patients. Laughter yoga has predominantly been used as a complementary therapy to enhance health and wellbeing of ordinary people and patients with chronic diseases. However, to date, few studies have evaluated the effects of this modern exercise on cancer patients undergoing chemotherapy in clinical settings, to the best of the authors' knowledge. the present study aimed to investigate the effects of Laughter Yoga on the health-related quality of life of cancer patients undergoing chemotherapy.MethodsThis study was a two-group randomized clinical trial on 69 cancer patients undergoing chemotherapy at Reza Radiotherapy and Oncology Center, Iran in 2018. Patients were randomly divided into intervention and control groups. The intervention group received laughter yoga for four sessions at one-week intervals. Each session consists of one part and lasts for 20-30 min. Patients' health-related quality of life was assessed before and after the laughter yoga sessions using Quality of Life Questionnaire European Organization for Research and Treatment of Cancer (EORTC QLQ-C30) version 3.0. SPSS Statistics (v.20 software was used to conduct Chi-square, independent t-test, Mann-Whitney, Wilcoxon and paired t-tests analyses of the data.ResultsThe number of participants in intervention and control groups were 34 and 35, there was no significant difference of demographic and disease related characteristics and pre-intervention HRQOL between two groups. In the intervention group, there is significant difference between pre- and post-intervention scores (Mean ± Standard Deviation) of emotional functioning (12.99 ± 10.49), physical functioning (0.78 ± 6.08), role functioning (3.43 ± 7.97), fatigue (-8.82 ± 22.01), pain (-8.33 ± 11.78), sleep disturbance (-15.68 ± 18.77), and global health and quality of life (6.37 ± 5.04) (p < 0.05). There was no significant change in the control group. Participants reported no adverse events.ConclusionsA structured laughter yoga intervention in a hospital setting effectively improved health-related quality of life for cancer patients undergoing chemotherapy. Benefits to many patients could be expected if this would become a part of routine care.Trial registrationThis study was registered in the Iranian Registry of Clinical Trials (no. IRCT20180429039463N1) on 21/08/2018.

Dataset Information

Preliminary Efficacy and Safety of Reishi & Privet Formula on Quality of Life Among Non-Small Cell Lung Cancer Patients Undergoing Chemotherapy: A Randomized Placebo-Controlled Trial.

Publications

Preliminary Efficacy and Safety of Reishi & Privet Formula on Quality of Life Among Non-Small Cell Lung Cancer Patients Undergoing Chemotherapy: A Randomized Placebo-Controlled Trial.

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