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Chemotherapeutic Toxicity clinical trials

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NCT ID: NCT05122247 Completed - Clinical trials for Chemotherapeutic Toxicity

Machine Learning to Predict Acute Care During Cancer Therapy

Chemo-SHIELD
Start date: January 3, 2022
Phase:
Study type: Observational

The objective of this study is to apply a validated machine-learning based model (SHIELD-RT, NCT04277650) to a cohort of patients undergoing systemic therapy as outpatient cancer treatment to generate an automatic system for the prediction of unplanned hospital admission rates and emergency department encounters.

NCT ID: NCT05092113 Recruiting - Mucositis Clinical Trials

The Efficacy and Safety of a Compound Glutamine Capsule in the Primary Prevention of Chemotherapy-induced Mucositis

Start date: June 30, 2021
Phase: Phase 3
Study type: Interventional

Chemotherapy regimens not only improve the survival of patients with gastric cancer and colorectal cancer, but also cause obvious adverse reactions of digestive tract, such as chemotherapy-induced oral mucositis, abdominal pain, diarrhea, constipation and so on. These adverse reactions seriously affect the patients' quality of life and the efficacy of chemotherapy. Glutamine is a conditionally essential amino acid in the human body. Previous studies have shown that oral glutamine can help to keep the integrity of mucosal epithelium during chemotherapy and reduce the gastrointestinal side effects caused by chemotherapy. The addition of glutamine to parenteral nutrition can better maintain nitrogen balance and reduce the incidence of infection-related complications. A compound glutamine capsule, composed of L-glutamine and the traditional Chinese herbal formula Si-Jun-Zi-Tang which composed of ginseng, Atractylodes macrocephala, Poria cocos and licorice, has been widely used in China for 23 years to treat many types of gastrointestinal diseases, including gastrointestinal reactions induced by radiotherapy and chemotherapy, ulcerative colitis, irritable bowel syndrome. However, so far, only a small sample of clinical trials have explored the role of glutamine in chemical mucositis, and there is a lack of prospective randomized controlled clinical trials to further verify its value in the prevention and treatment of chemical mucositis. The purpose of this study is to observe the efficacy and safety between a compound glutamine capsule and placebo in the prevention of chemotherapy-induced mucositis in patients with gastric cancer and colorectal cancer in a prospective, randomized, double-blind clinical trial.

NCT ID: NCT04988971 Recruiting - Mucositis Clinical Trials

The Efficacy and Safety of a Compound Glutamine Capsule in the Prevention of Chemotherapy-induced Mucositis

Start date: June 30, 2021
Phase: Phase 3
Study type: Interventional

Chemotherapy regimens not only improve the survival of patients with gastric cancer and colorectal cancer, but also cause obvious adverse reactions of digestive tract, such as chemotherapy-induced oral mucositis, abdominal pain, diarrhea, constipation and so on. These adverse reactions seriously affect the patients' quality of life and the efficacy of chemotherapy. Glutamine is a conditionally essential amino acid in the human body. Previous studies have shown that oral glutamine can help to keep the integrity of mucosal epithelium during chemotherapy and reduce the gastrointestinal side effects caused by chemotherapy. The addition of glutamine to parenteral nutrition can better maintain nitrogen balance and reduce the incidence of infection-related complications. A compound glutamine capsule, composed of L-glutamine and the traditional Chinese herbal formula Si-Jun-Zi-Tang which composed of ginseng, Atractylodes macrocephala, Poria cocos and licorice, has been widely used in China for 23 years to treat many types of gastrointestinal diseases, including gastrointestinal reactions induced by radiotherapy and chemotherapy, ulcerative colitis, irritable bowel syndrome. However, so far, only a small sample of clinical trials have explored the role of glutamine in chemical mucositis, and there is a lack of prospective randomized controlled clinical trials to further verify its value in the prevention and treatment of chemical mucositis. The purpose of this study is to observe the efficacy and safety between a compound glutamine capsule and placebo in the prevention of chemotherapy-induced mucositis in patients with gastric cancer and colorectal cancer in a prospective, randomized, double-blind clinical trial.

NCT ID: NCT04965532 Not yet recruiting - Clinical trials for Chemotherapeutic Toxicity

Residual Neuromuscular Block of Rocuronium in Chemotherapy Patients Under Sevoflurane Anesthesia

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Chemotherapy causes motor nerve dysfunction and degeneration that may alter the response to neuromuscular blocking drugs. To analyse the risk of residual neuromuscular block (RNMB) induced by rocuronium given in standard doses to patients who undergo chemotherapy within three months.

NCT ID: NCT04843410 Completed - Clinical trials for Chemotherapy-induced Peripheral Neuropathy

Effect of Exercise in the Management of Peripheral Neuropathy

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Chemotherapy-associated peripheral neuropathy is a common complication in patients receiving taxane and platinum-based chemotherapy. Peripheral neuropathy may cause the patient's daily life activities to be hindered, quality of life to deteriorate, treatment dose reduced, or even discontinuation of treatment. In the literature, different studies have been carried out using many pharmacological and non-pharmacological approaches in the management of this problem, but so far, any approach that has been shown to be effective in its management has not been clearly defined. One of the approaches whose effectiveness is evaluated in management is exercise. There have been published case reports and several experimental studies examining small patient groups on this subject, and it has been shown to have significant benefits in the management of peripheral neuropathy. This study was planned to determine whether exercise is an effective method in the management of chemotherapy-associated peripheral neuropathy in oncology patients.

NCT ID: NCT04816656 Completed - Covid19 Clinical Trials

An Integrated Digital PROM-platform for Cancer Patients During the COVID-19 Pandemic

COVID-ONCO
Start date: August 3, 2020
Phase: N/A
Study type: Interventional

During the COVID-19 pandemic, patients with cancer are subject to multiple risks (e.g. frequent hospital visits, increased infection risk, more severe clinical course, discontinued cancer treatment etc.). Patients undergoing cancer therapy are also faced with several Quality of Life - impairing side effects. In the case of a positive COVID-19 cancer patient, the need and intensity of treating must be weighed against the possible higher risk of developing severe complications in the course of a COVID-19 infection. Nevertheless, both for COVID-19 positive and negative patients who will continue or discontinue cancer treatment throughout the pandemic, providing supportive care is more important than ever. Digitally monitoring patient-reported outcome measures (PROMs) could offer a solution to improve the supportive care measures during cancer treatment, and certainly in times of COVID-19. Digitalized PROMS could significantly contribute to improved communication, patient satisfaction, supportive care, monitoring of cancer treatment, and detection of problems. To date, clinical trials investigating the benefits of digital PROMS in patients with cancer during the current COVID-19 pandemic are lacking. At the Jessa Hospital, the investigators already have experience in collecting PROMs via a digital platform (Awell Health) since 2019 for patients with breast cancer undergoing chemotherapy using validated QoL questionnaires. The overall aim of this project is to prospectively evaluate the impact of a COVID-19 infection on the severity of the cancer therapy-related complications and the QoL of patients with cancer undergoing chemotherapy using a digital PROMs-platform.

NCT ID: NCT04799080 Completed - Breast Cancer Clinical Trials

Chemotherapy-induced Peripheral Neuropathy (CIPN) on Motor and Sensory Function

Start date: March 6, 2021
Phase:
Study type: Observational

As cancer survival rates have been increased due to technological developments and early detection strategies, there has been been a growing need to assess the effect of long-term complications and adverse effects upon patients' functionality and quality of life. Chemotherapy, which is accepted to be the body of systemic adjuvant therapy is attributed to long-term survival, yet some side effects such as sarcopenia, loss of muscle strength and functional capacity, fatigue, and sensory disturbances due to the neurotoxic effects have been well known. Chemotherapy-induced peripheral neuropathy (CIPN) is a condition that is characterized by main loss of cutaneous sensation especially in the distal part of the extremities. CIPN affects approximately 30-40% of patients with cancer undergoing chemotherapy. Loss of sensation in distal sides of upper and lower extremities may cause not only deterioration of fine hand skills but also loss of balance and thereby one's mobility and independence are detrimentally affected. Thus, this study is aimed to assess CIPN in patients with cancer undergoing chemotherapy in a longitudinal design by assessing the cutaneous function of the sensory nerves and related effect of motor function.

NCT ID: NCT04754672 Recruiting - Colorectal Cancer Clinical Trials

Aerobic Fitness or Muscle Mass Training to Improve Colorectal Cancer Outcome

AMICO
Start date: March 2, 2021
Phase: N/A
Study type: Interventional

Evidence from randomized controlled trials shows that exercise during cancer treatment benefits physical fitness, fatigue and quality of life. Since the effect of exercise on clinical outcome is currently unknown, exercise is not included as integral part of standard cancer care. Moreover, evidence regarding the optimal exercise prescription in terms of type and dose is lacking. To maintain quality of life in patients receiving palliative treatment with chemotherapy, toxicity-induced modifications in the prescribed chemotherapy dose are common. Such modifications - occurring in 40% of patients with metastatic colorectal cancer - may reduce benefit of treatment. The investigators hypothesize that exercise prevents chemotherapy dose modifications by reducing toxicity and enhancing psychological strength. Additionally, based on studies in rodents and preliminary data in patients with cancer, the researchers hypothesize that exercise has beneficial effects on the functionality of the natural killer cells, which play an important role in the innate immune defense against cancer. Both, fewer dose modifications and improved immune function may improve progression-free survival. This study is a three-armed trial comparing resistance exercise, aerobic interval exercise and usual care in patients with metastatic colorectal cancer to select the optimal exercise prescription for preventing chemotherapy dose modifications. The trial will use a Bayesian adaptive multi-arm multi-stage design with several interim analyses after which an ineffective study arm can be dropped early. This novel design makes the trial more efficient and reduces patients' exposure to suboptimal study arms. Evidence regarding the exercise effects on i) clinical outcome, ii) the optimal exercise prescription, and iii) the underlying mechanisms, elucidates the potential of exercise to boost benefit from chemotherapy treatment. This evidence provides leads to improve progression-free survival and quality of life of patients suffering from one of the leading causes of cancer death worldwide.

NCT ID: NCT04694794 Completed - Chemotherapy Effect Clinical Trials

Diminish Chemotherapy Related Side Effects Through Patient Education

D-CRSE
Start date: March 24, 2021
Phase: N/A
Study type: Interventional

Currently, there is a lack of patient education materials regarding cytotoxic chemotherapy side effects, research supported treatments, and the utilization of CAM by cancer patients at Penn State Cancer Institute. The investigators aim to develop an educational brochure, which educates patients about the chemotherapy side effects they may experience, and provide them with the tools to address the problem themselves, know when to contact their medical oncologist, and understand when it is appropriate to go to the Emergency Department. By educating patients regarding these problems, patient anxiety may decrease, the number of calls into the oncologist office may decrease, and Emergency Department visits may decrease, which would decrease costs for the patient, the hospital, and the health system. If this intervention is found to be useful and impactful, it can be further utilized within the Cancer Institute by other disease teams, by other Penn State institutions, or by other institutions across the country.

NCT ID: NCT04663178 Completed - Clinical trials for Chemotherapeutic Toxicity

Foot Bath and Chemotherapy Induced Fatigue

Start date: November 15, 2017
Phase: N/A
Study type: Interventional

Background: In a limited number of studies conducted with the participation of cancer patients, it has been reported that warm water bath may be beneficial for management of cancer-related fatigue. Objective: This experimental study was conducted to evaluate the effect of warm salt water foot bath applied to reduce the chemotherapy-induced fatigue. Interventions/Methods: Seventy-nine patients who were experiencing moderate or higher level of fatigue were included in this study conducted between November 2017-February 2018. 42 of the patients were assigned to the experimental group and 37 patients were assigned to the control group. A training booklet about chemotherapy-induced fatigue were given to all patients. In addition, the experimental group was asked to perform 20-minute warm salt water application to their feet for a week after the treatment by explaining and showing the video prepared about the preparation and practice of warm salt water foot bath. Subsequently, the patients were called by phone every day for one week to record their fatigue levels. Results: The 7-day fatigue course of both groups was similar. However the physical, emotional, affective and cognitive distress related to fatigue decreased in the experimental group but did not decrease in the control group. Conclusion: The warm salt water footbath may be an effective approach in enhancing fatigue related quality of life. However, it is needed to conduct more comprehensive studies to express the effectiveness. Implications to Practice: Nurses can propose the use of the warm salt water footbath in the management of chemotherapy induced fatigue. Keywords: Chemotherapy Induced Fatigue, Warm salt water foot bath