scholarly journals Effect of hydroxychloroquine on COVID-19 prevention in cancer patients undergoing treatment: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
H. Rahimi ◽  
A. Allahyari ◽  
S. Ataei Azimi ◽  
M. Kamandi ◽  
Z. Mozaheb ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Sample Size ◽  
Cancer Patients ◽  
Computerize Tomography ◽  
Controlled Trial ◽  
Metastatic Breast ◽  
Control Group ◽  
Nasopharyngeal Swab ◽  
First Line ◽  
Randomized Controlled

Abstract Objectives In this study, we will investigate the effect of hydroxychloroquine on the prevention of novel coronavirus disease (COVID-19) in cancer patients being treated. Trial design This is a two-arm, parallel-group, triple-blind, phase 2–3 randomized controlled trial. Participants All patients over the age of 15 years from 5 types of cancer will be included in the study. Patients with acute lymphoid and myeloid leukemias in the first line treated with curative intent, patients with high-grade non-Hodgkin’s lymphoma treated with leukemia regimens, and patients with non-metastatic breast and colon cancer in the first line of treatment will enter the study. Intervention and comparator Patients are randomly assigned to two groups: one being given hydroxychloroquine and the other is given placebo. During 2 months of treatment, the two groups will be treated with hydroxychloroquine every other day with a single 200-mg tablet (Amin® Pharmaceutical Company, Isfahan, Iran) or placebo (identical in terms of shape, color, and smell). Patients will be monitored for COVID-19 symptoms during follow-up period. If any COVID-19-related signs or symptoms occur, they will be examined, thoroughly, investigated with a high resolution computerize tomography (CT) scan of the lungs and nasopharyngeal swab assessed by RT-PCR for SARS-CoV-2 virus. This study will be performed in five centers affiliated to Mashhad University of Medical Sciences, Mashhad, Iran. Main outcomes The primary end point of this study is to investigate the incidence of COVID-19 in patients being treated for their cancer and receiving prophylactic Hydroxychloroquine. Randomization Randomization will be performed using random permuted blocks. By using online website (www.randomization.com), the randomization sequence will be produced by quadruple blocks. The allocation ratio in intervention and control groups is 1:1. Blinding (masking) Participants and caregivers do not know whether the patient is in the intervention or the control group. Those assessing the outcomes and data analyzer are also blinded to group assignment. Sample size The calculated total sample size is 60 patients, with 30 patients in each group.

Cluster Symptoms Reduction via Telephone-Based Intervention in Thai Breast Cancer Patients Undergoing 4-Cycle Adjuvant Chemotherapy: A Randomized-Controlled Trial

2021 ◽  
Vol 104 (6) ◽  
pp. 887-894
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Adjuvant Chemotherapy ◽  
Energy Conservation ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Control Group ◽  
Breast Cancer Patients ◽  
Randomized Controlled ◽  
Experimental Group

Background: Cluster symptoms are a common occurrence in breast cancer patients undergoing chemotherapy. The telephone is a well-recognized, convenient device for reaching out to patients for monitoring and managing their symptoms in an efficient, prompt, and appropriate manner. Objective: To investigate the efficacy of telephone-based intervention to achieve energy conservation among breast cancer patients with the aim of alleviating fatigue, pain, sleep disturbance, and depression. Materials and Methods: The present study was a two-armed, randomized control trial conducted in the university hospital between March and September 2019. Seventy-four breast cancer patients, receiving four courses of adjuvant chemotherapy, were randomly recruited and assigned into the experimental group and the control group. One face-to-face intervention interview for energy conservation was conducted, followed by 20-minutes telephone brief counselling and assessment sessions, scheduled on day 1, 2, 7, and 14. Results: The scores for symptoms of median fatigue and pain in the experimental group were shown to be significantly reduced at the end of the study as compared to those scores within the control group (p<0.05). Similarly, scores for median sleep time and depression were greater at the end of cycle 1 and highest in cycle 2 (p<0.05, 0.001, respectively). Physical activity levels were also higher in the experimental group than in the control group in every cycle, with a statistical significance (p<0.001). Conclusion: The present study intervention demonstrated an effectiveness for the reduction of cluster symptoms. Further studies would be needed in a larger population scale in the customary, randomized controlled trial manner. Keywords: Cancer; Energy conservation; Fatigue; Pain; Sleep; Telephone

scholarly journals The effect of cryotherapy on chemotherapy induced oral mucositis in Egyptian cancer patients: A randomized controlled trial

2019 ◽  
Vol 9 (11) ◽  
pp. 63
Author(s):  
Hanan Mohamed Mohamed Soliman
Keyword(s):  
Randomized Controlled Trial ◽  
Cancer Patients ◽  
Oral Mucositis ◽  
Health Care Professionals ◽  
Controlled Trial ◽  
Routine Care ◽  
Control Group ◽  
Adverse Side Effect ◽  
Randomized Controlled ◽  
Oral Cryotherapy

Background and objective: Oral Mucositis (OM) is a common adverse side-effect caused by cancer treatments (chemotherapy and/or radiotherapy).  And can lead to mucosa toxicity. Patients with OM may experience extreme pain and may not be able to eat, drink and talk and, as a result, their quality of life is impaired. Treatment and prevention of OM in adult patients treated with chemotherapy are challenging issues for health care professionals. The aim of this study was to evaluate the effect of cryotherapy on incidence and severity of chemotherapy-induced OM and OM related pain in patients treated with combined chemotherapy (Fluorouracil and Leucovorin).Methods: This study is a randomized controlled trial with a random assignment to cryotherapy and control groups. The study was conducted on 40 cancer patients who underwent chemotherapy. The 20 patients in cryotherapy group were received instructions for sucking ice cubes in their mouth for five minutes before, during and shortly after chemotherapy. The 20 patients in control group received routine care. OM and pain severity were evaluated at 7th, 14th and 21st days of the study after chemotherapy using WHO Mucositis grading and-Numeric Pain Rating Scale.Results: In the majority of patients in cryotherapy group, oral Mucositis was not detected (Grade 0) at 7th, 14th and 21st days similarly incidence of grade 1 and 2 of OM in cryotherapy group significantly lowered when compared with control group where p < .001. During the study period, patients in the control group exhibit a significantly higher level of oral discomfort (p = .001).Conclusions: Oral cryotherapy due to its easy administration, tolerability and lack of adverse effects which makes it a very important method for decreasing the severity and incidence of OM and OM associated pain. The oncology nurses have a pivotal role in the application and success of cryotherapy.

scholarly journals A Randomized Controlled Trial of mHealth Mindfulness Intervention for Cancer Patients and Informal Cancer Caregivers: A Feasibility Study Within an Integrated Health Care Delivery System

2019 ◽  
Vol 18 ◽  
pp. 153473541985063 ◽  
Author(s):  
Ai Kubo ◽  
Elaine Kurtovich ◽  
MegAnn McGinnis ◽  
Sara Aghaee ◽  
Andrea Altschuler ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cancer Patients ◽  
Care Delivery ◽  
Controlled Trial ◽  
Informal Caregivers ◽  
Intervention Group ◽  
Control Group ◽  
Mindfulness Intervention ◽  
Mindfulness Skills ◽  
Randomized Controlled

Purpose: To assess feasibility and preliminary efficacy of a mobile/online-based (mHealth) mindfulness intervention for cancer patients and their caregivers to reduce distress and improve quality of life (QoL). Material and Methods: Two-arm randomized controlled trial within Kaiser Permanente Northern California targeting cancer patients who received chemotherapy and their informal caregivers. The intervention group received a commercially available mindfulness program for 8 weeks. The wait-list control group received usual care. We assessed feasibility using retention and adherence rates and obtained participant-reported data on distress, QoL, sleep, mindfulness, and posttraumatic growth before and immediately after the intervention. Results: Ninety-seven patients (median age 59 years; female 69%; 65% whites) and 31 caregivers (median age 63 years; female 58%; 77% whites) were randomized. Among randomized participants, 74% of the patients and 84% of the caregivers completed the study. Among those in the intervention arm who initiated the mindfulness program, 65% practiced at least 50% of the days during the intervention period. We observed significantly greater improvement in QoL among patients in the intervention arm compared with controls. Caregivers in the intervention group experienced increased mindfulness compared with controls. Participants appreciated the convenience of the intervention and the mindfulness skills they obtained from the program. Conclusion: We demonstrated the feasibility of conducting a randomized trial of an mHealth mindfulness intervention for cancer patients and their informal caregivers. Results from fully powered efficacy trials would inform the potential for clinicians to use this scalable intervention to help improve QoL of those affected by cancer and their caregivers.

scholarly journals Effectiveness of self-help workbook intervention on quality of life in cancer patients receiving chemotherapy: results of a randomized controlled trial

2020 ◽  
Author(s):  
Toshimi Takano ◽  
Ayako Matsuda ◽  
Noriko Ishizuka ◽  
Yukinori Ozaki ◽  
Koichi Suyama ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Cancer Patients ◽  
Emotional Functioning ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Self Help

Abstract Background: A self-help workbook is expected to support cancer patients to cope with physical and psychosocial distress, to facilitate communication with medical staff, and to improve quality of life (QOL). We conducted a randomized controlled trial to evaluate the effectiveness of a self-help workbook intervention on QOL and survival. Methods: From June 2014 to March 2015, patients with breast, colorectal, gastric, and lung cancer receiving outpatient chemotherapy were randomized into an intervention group (n = 100) or control group (n = 100). Intervention group participants received workbooks originally made for this study, read advice on how to cope with distress, and filled out questionnaires on the workbooks periodically. EORTC QLQ-C30 was evaluated at baseline, at 12 weeks, and at 24 weeks. The primary endpoint was Global Health Status / QOL scale (GQOL). Results: No significant interaction was observed between the intervention and time in terms of GQOL or any of the functional scales. Among the 69 patients who continued cytotoxic chemotherapy at 24 weeks, the intervention was significantly associated with improved emotional functioning scores (P = 0.0007). Overall survival was not significantly different between the two groups. Conclusions: Self-help workbook intervention was feasible in cancer patients receiving chemotherapy. Although the effect of the intervention was limited, the intervention may improve emotional functioning among patients who receive long-term cytotoxic chemotherapy.Trial registration: UMIN Clinical Trials Registry, UMIN000012842. Registered 14 January 2014, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015002

Efficacy of Gastroplegia Patch on treating postoperative gastroplegia: A multicenter, double-blind, randomized controlled trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 10110-10110
Author(s):  
Tian Zhou ◽  
Qin Zhou ◽  
Yanbin Wang ◽  
Yingjiang Ye ◽  
Yantao Tian ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Tube Feeding ◽  
Control Group ◽  
Double Blind ◽  
Randomized Controlled ◽  
Patch Group ◽  
Gastroenterological Cancer

10110 Background: Postoperative gastroplegia is common in digestive cancer patients and there were no effective treatments. Gastroplegia Patch is an external-used Chinese Herbal Medicine recipe. It has been applied clinically for more than ten years, which showed good effect. We conducted this study to verify its safety and efficacy on the symptoms of postoperative gastroplegia. Methods: This clinical trial was designed as a multi-center, double-blind, superior effect, randomized controlled trial. It has been registered in ISRCTN (No.18291857) before initiation and was monitored by the third party. Patient inclusion criteria: 1. Gastroenterological cancer patient who was diagnosed as post-surgery gastroplegia, could not eat and need tube feeding (parenteral nutrition or with Jejunum nutrient canal); 2. The local identification of abdomen is cold pattern, which means this kind of patient prefers heat to cold, likes hot food and hates cold ones. Eligible participants were randomized into two arms, placebo arm and Patch arm, respectively. Beside the basic treatments (nutrition support, gastrointestinal decompression, promoting gastric dynamics medicine), placebo or Gastroplegia Patch was applied in control group or Patch group, respectively. Placebos or the patches were allocated at two acupuncture points ( Zhongwan and Shenque). The intervention course was 14 days or reached primary endpoint. The primary endpoint was able to eat without tube feeding. Results: All the 120 eligible participants (60 per arm) were recruited from four AAA hospitals in Beijing, China. Analysis was conducted based on intent-to-treat strategy. After the intervention, 68.33% of the participants in the Patch group were able to eat without tube feeding, which significantly higher than that of 41.67% in the control group (p = 0.003). It took 8 days on average in the Patch group to show effect, which significantly faster than that of 10 days in the control group (p = 0.017). The incidences of adverse events were compatible between the two arms (p = 0.244). Conclusions: Gastroplegia Patch is safe and effective in treating postoperative gastroplegia in gastroenterological cancer patients with cold syndrome. Clinical trial information: 18291857.

scholarly journals A Randomized Controlled Trial of a Non-pharmacological Intervention for Cancer-Related Dyspnea

2020 ◽  
Vol 10 ◽  
Author(s):  
Patsy Yates ◽  
Janet Hardy ◽  
Alexandra Clavarino ◽  
Kwun M. Fong ◽  
Geoffrey Mitchell ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Functional Status ◽  
Cancer Patients ◽  
Rating Scale ◽  
Controlled Trial ◽  
Public Hospitals ◽  
Pharmacological Intervention ◽  
Control Group ◽  
Pharmacological Interventions ◽  
Randomized Controlled

Objectives: To evaluate the efficacy of a brief tailored non-pharmacological intervention comprising breathing retraining and psychosocial support for managing dyspnea in cancer patients.Design: Multicenter, single blinded, parallel group, randomized controlled trial.Setting: Four major public hospitals, Brisbane, Australia.Participants: One hundred and forty four cancer patients, including 81 who received an 8-week tailored intervention and 63 who received standard care.Inclusion Criteria: Diagnosis of small or non-small cell lung cancer, mesothelioma or lung metastases; completed first line therapy for the disease; average dyspnea rating &gt;2 on (0–10) rating scale in past week; anticipated life expectancy ≥3 months.Outcomes: The primary outcome measure was change in “worst” dyspnea at 8 weeks compared to baseline. Secondary outcomes were change in: dyspnea “at best” and “on average”; distress; perceived control over dyspnea; functional status, psychological distress; and use of non-pharmacological interventions to manage dyspnea at 8 weeks relative to baseline.Results: The mean age of participants was 67.9 (SD = 9.6) years. Compared to the control group, the intervention group demonstrated a statistically significant: (i) improvement in average dyspnea from T1(M = 4.5, SE = 0.22) to T3 (M = 3.6, SE = 0.24) vs. (M = 3.8, SE = 0.24) to (M = 4.1, SE = 0.26); (ii) greater control over dyspnea from T1 (M = 5.7, SE = 0.28) to T3 (M = 7.5, SE = 0.31) vs. (M = 6.8, SE = 0.32) to (M = 6.6, SE = 0.33); and (iii) greater reduction in anxiety from T1 (M = 5.4, SE = 0.43) to T3 (M = 4.5, SE = 0.45) vs. (M = 4.2, SE = 0.49) to (M = 4.6, SE = 0.50). This study found no intervention effect for best and worst dyspnea, distress from breathlessness, functional status, and depression over time.Conclusions: This study demonstrates efficacy of tailored non-pharmacological interventions in improving dyspnea on average, control over dyspnea, and anxiety for cancer patients.Clinical Trial Registration: The trial is registered at the Australian New Zealand Clinical Trials Registry (http://www.anzctr.org.au). The registration number is ACTRN12607000087459.

Sign in / Sign up

Export Citation Format

Share Document