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Chemotherapeutic Toxicity clinical trials

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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: 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: NCT04632797 Recruiting - Clinical trials for Chemotherapy-induced Peripheral Neuropathy

Cryotherapy vs. Cryocompression for Preventing Chemotherapy-induced-peripheral-neuropathy in Women Undergoing Chemotherapy

Start date: February 3, 2020
Phase: N/A
Study type: Interventional

This study's aim is to show a benefit of Cryocompression (cooling hands with additional compression of the hands) in comparison to Cryotherapy (just cooling hands) in female cancer patients (with gynecological cancer) receiving chemotherapy with taxanes. Patients who are not eligible for either cryocompression or cryotherapy are included in a control group. The expected benefits with additional compression to the cryotherapy are reduction of chemotherapy induced polyneuropathy and reduced nail changes.

NCT ID: NCT04319601 Recruiting - Chemotherapy Effect Clinical Trials

Rituximab Combined With Chidamide and Lenalidomide for r/r AITL

AITL
Start date: March 13, 2020
Phase: N/A
Study type: Interventional

This study is designed to explore the effeicency and toxicities of rituximab combined with chidamide and lenalidomide in patients with relapsed or refractory AITL.

NCT ID: NCT04207437 Recruiting - Cancer Clinical Trials

Daily Hand-Held Vibration Therapy

Start date: December 6, 2021
Phase: N/A
Study type: Interventional

The purpose of this pilot study is to determine the safety and feasibility of a daily 3-minute hand-held vibration therapy intervention to reduce the severity of CIPN in the hands. The investigators hypothesize that daily vibration therapy can reduce the severity of patient's CIPN in their hands and improve CIPN-related quality of life. The hope is that results from this study will provide early data on the feasibility, efficacy, and most importantly, safety, of daily 3-minute hand-held vibration therapy needed to justify future clinical trials examining vibration therapy as a potential option for treating CIPN in the future.

NCT ID: NCT04053439 Recruiting - Lymphoma Clinical Trials

Clonal Hematopoiesis is a Risk Factor for Chemotherapy-Related Complications

Start date: August 8, 2019
Phase:
Study type: Observational

'CHIP' stands for Clonal Hematopoiesis of Indeterminate Significance, which are mutations in bone marrow stem cells that give that population of cells a survival or 'clonal' advantage for growth. This study investigates whether CHIP in lymphoma patients aged 60 years and older is a risk factor for chemotherapy-related complications like low blood counts, infections, cardiac events, hospitalizations, dose delays and dose reductions, and failure to recover normal blood counts after chemotherapy finishes.

NCT ID: NCT03792269 Recruiting - Chemotherapy Effect Clinical Trials

Intraperitoneal and System Chemotherapy Versus XELOX as First-line Chemotherapy for mCRC

Start date: January 1, 2016
Phase: Phase 2
Study type: Interventional

XELOX as first-line treatment regimen has limited efficacy against patients with metastatic colorectal cancer (mCRC). Peritoneal metastasis is one of the most lethal factor for mCRC. Intraperitoneal chemotherapy has became a widely accepted strategy in the treatment of peritoneal dissemination. We hypothesized that combined multi-channel administration, such as intraperitoneal chemotherapy, oral chemotherapy, and intravenous chemotherapy, can produce better results than XELOX for first-line treatment for mCRC patients.

NCT ID: NCT03785704 Recruiting - Breast Neoplasms Clinical Trials

Clinical Study of Xinmailong Injection on Reducing Cardiovascular Toxicity in Adjuvant Chemotherapy in Breast Cancer

Start date: January 1, 2019
Phase: Phase 2
Study type: Interventional

Totally 60 subjects will be included in the study. The present study was aimed to observe and evaluate the effect of Xinmailong injection on reducing cardiovascular toxicity associated with adjuvant chemotherapy after breast cancer surgery. The primary endpoint was 6 months of cardiac safety. Secondary endpoints included 3 months of cardiac safety, adverse events (AE), severe adverse events (SAE), and DFS.

NCT ID: NCT03640117 Recruiting - Breast Cancer Clinical Trials

The Value of Geriatric Assessments in Older Patients With Breast Cancer

Start date: April 1, 2018
Phase:
Study type: Observational

Elderly cancer patients are a special group, often complicated by a variety of chronic diseases, which bring serious obstacles to surgery and adjuvant treatment. It is for these reasons that most patients with high-level evidence-based randomized controlled clinical trials will be part of these patients. Exclusions ultimately lead to a lack of standards for the treatment of elderly breast cancer patients, especially the chemotherapy. Investigators' purpose was to determine whether geriatric assessments are associated with completion of a chemotherapy course, grade III/IV toxicity or survival in older adults with breast cancer in older patients. Investigators want to prospectively enroll breast cancer patients with age ≥70 years. By recording the pre-treatment baseline laboratory tests and geriatric assessments, through questionnaires, including Karnofsky performance status(KPS), Eastern Cooperative Oncology Group(ECOG), Mini Nutritional Assessment(MNA), Activity of daily living(ADL), Instrumental activities of daily living(IADL), Mini-Mental State Examination(MMSE), Geriatric Depression Scale(GDS), G-8, Vulnerable Elders Survey-13(VES-13) and FRAIL, Tilburg. Investigators want to learn the relationship between the geriatric assessments and chemotherapy toxicity, chemotherapy completion and overall survival. Establish a model for predicting chemotherapy side effects in old breast cancer patients.

NCT ID: NCT03486340 Recruiting - Clinical trials for Acute Coronary Syndrome

Prevention of Chest Pain in Chemo-treated Cancer Patients

CATCH
Start date: April 11, 2018
Phase: N/A
Study type: Interventional

This is a prospective, exploratory, randomised clinical trial. Patients with diagnosed cancer that are to be treated with 5-fluorouracil (5-FU) will be randomised into standard oncological treatment or a cardiological assessment prior to the 5-FU treatment. The investigators hypothesize that aggressive management of ischemic risk factors in asymptomatic patients will reduce the number of hospitalisations and investigations for acute coronary syndrome during and after 5-FU treatment and that patients with high coronary artery calcium scores are more likely to experience chest pain during the treatment with 5-FU.