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NCT ID: NCT04669977 Recruiting - Clinical trials for Chemotherapy-induced Peripheral Neuropathy

Effects of a Glucoside- and Rutinoside-rich Material in Chemotherapy-induced Peripheral Neuropathy and Related Symptoms

Start date: December 2, 2020
Phase: N/A
Study type: Interventional

Chemotherapy-induced peripheral neuropathy (CIPN is common among cancer patients during or after chemotherapy, and the currently available drugs cannot effectively manage the symptoms. Besides, CIPN causes fatigue, anxiety, and depression. CIPN is featured by the interference of interleukin (IL) pathways, among which escalation of IL-17 is predominant, suggesting that IL-17 may be manipulated to reduce the inflammation or the immunological disturbance. Cyanidin, a type of glucosides, has been proved to behave like an IL-17 inhibitor. We have identified a food material that contains large amounts of glucosides and rutinosides - mulberry juice. The current proposal aims to explore the effect of this IL-17 inhibitor-rich material in CIPN and related symptoms. We plan to divide the potential participants into severe pain and mild pain group to conduct two human studies. A single-blinded randomized controlled design is adopted to compare the effects of this crude material between the experimental group and the control group in (1) pain and CIPN of the severe pain participants and (2) fatigue, anxiety, and depression in the mild pain participants. IL and other immune markers will be tested as evidence of improvement of inflammation status. We expect a decrement in pain, CIPN, fatigue, anxiety, and depression severity with the intake of this IL-17 inhibitor-rich material among cancer patients undergoing chemotherapy.

NCT ID: NCT04635956 Recruiting - Chemotherapy Clinical Trials

Camrelizumab Combined With Chemotherapy for Recurrent or Advanced Cervical Neuroendocrine Carcinomas

Start date: November 15, 2020
Phase: Phase 2
Study type: Interventional

Recurrent or advanced cervical neuroendocrine carcinoma (NEC) is refractory to multimodal treatment, even to extensive therapy. Chemotherapy, consisting of platinum and etoposide, remains the main therapy for recurrent or advanced cervical NEC. In addition, bevacizumab has shown progression-free benefits in recurrent or advanced cervical cancer. Case report suggested anti-PD-1 antibody may have antitumor activities in NEC. Based on these evidences, a phase 2, single arm trial is conducted to explore the objective response rate (ORR) of platinum/etoposide/bevacizumab/anti-PD-1 antibody (camrelizumab) for the treatment of recurrent or advanced cervical NEC. This trial is to enroll 20 patients, who would accept 6 courses of platinum/etoposide/bevacizumab/camrelizumab. If the patient achieved complete or partial remission, a total period of 12 months bevacizumab/camrelizumab will be given as maintain therapy. The primary endpoint is ORR. The second endpoints are severe adverse events according to criteria of Common Terminology Criteria for Adverse Events (CTCAE) and iRECIST Guideline, and critical changes of laboratory testing.

NCT ID: NCT04633655 Recruiting - Quality of Life Clinical Trials

International CIPN Assessment and Validation Study

ICAVS
Start date: June 8, 2020
Phase:
Study type: Observational

This is an observational study of chemotherapy-induced peripheral neurotoxicity (CIPN) patients to be investigated prospectively in order to assess responsiveness of a set of outcome measures in an international multi-center study.

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: NCT04621721 Recruiting - Clinical trials for Breast Cancer Female

Home-Based Physical Activity Intervention for Taxane-Induced CIPN

B-HAPI
Start date: August 14, 2020
Phase: N/A
Study type: Interventional

This two-group, randomized control trial (RCT) will test the effects of a home-based, 16 week gait/balance training plus resistance (exercise bands) exercise program as compared to an educational cancer survivorship attention control condition to address persistent taxane-induced peripheral neuropathy in 312 patients treated for invasive breast cancer with taxanes at 1 year or more after completion of therapy. Assessments of lower extremity muscle strength, gait/balance, nerve conduction, neuropathy symptoms, and quality of life (QOL) will be performed. The proposed exercise intervention addresses gait/balance impairments and motor (resistance) components of taxane-induced peripheral neuropathy. The mechanism by which the intervention achieves the proposed outcomes is though 1) increasing endoneurial blood flow to peripheral nerves and mitochondria resulting in reduction in neuropathic symptoms (including pain) and clinical manifestations of peripheral neuropathy, while improving gait/balance in those with persistent neuropathy; 2) The subsequent increase in nutrient supply allows the mitochondria to function more efficiently, and may alleviate the neuropathic manifestations of taxane-induced peripheral neuropathy. 15 This is the first study proposing to test the home-delivery of an exercise intervention specifically aimed at persistent (long-term) taxane-induced neuropathy. If successful, this study will provide the only evidence-based intervention for patients suffering from persistent neuropathy from neurotoxic chemotherapy. Additionally, the home-delivery format makes this intervention easily translated into clinical practice. Specific Aims: In a sample of patients who completed a taxane-containing chemotherapy regimen (> 1 year) for breast cancer and who have a persistent neuropathy (VAS score of > 3) the specific aims of this RCT are: 1. To test the efficacy of a 16-week -delivered program of gait/balance training plus resistance exercise, compared to an educational attention control condition in increasing muscle strength, improving gait/balance and nerve conduction parameters, decreasing the severity of taxane-induced peripheral neuropathy symptoms, and increasing quality of life. 2. To evaluate for differences in muscle strength, gait/balance, sensory (sural) and motor (peroneal) nerve conduction, peripheral neuropathy symptoms, and quality of life (QOL) between patients who receive the exercise program, compared to those in an educational attention control condition controlling for age, BMI, taxane cycles and intervals, neuropathic pain, neuropathy/pain medications, current resistance exercise participation and falls/near falls experienced.

NCT ID: NCT04600960 Recruiting - Clinical trials for Chemotherapy-induced Thrombocytopenia

Eltrombopag for Chemotherapy-induced Thrombocytopenia

Start date: December 31, 2020
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy and safety of eltrombopag to treat chemotherapy-induced thrombocytopenia in solid tumors

NCT ID: NCT04586530 Recruiting - Clinical trials for Chemotherapy-related Cognitive Dysfunction

Telehealth and Memory Study

TAMS
Start date: March 18, 2021
Phase: N/A
Study type: Interventional

The overall purpose of this trial is to confirm the efficacy of Memory and Attention Adaptation Training (MAAT), a cognitive-behavioral therapy (CBT) for treatment of chemotherapy-related cognitive dysfunction among (female or male) breast cancer survivors. This is a multi-center, multi-clinician randomized control trial (MAAT vs. supportive therapy attention control condition). This trial will also evaluate a sub-sample of survivors pre-and post treatment with functional magnetic resonance imaging (fMRI) in a working memory task to evaluate pre-to-post treatment brain activation patterns to elucidate underlying mechanisms of clinical therapeutic change.

NCT ID: NCT04560673 Recruiting - Clinical trials for Malignant Solid Neoplasm

Duloxetine and Neurofeedback Training for the Treatment of Chemotherapy Induced Peripheral Neuropathy

Start date: July 10, 2020
Phase: Phase 2
Study type: Interventional

This phase II trial investigates how well duloxetine and neurofeedback training work in treating patients with chemotherapy induced peripheral neuropathy. Duloxetine is a type of serotonin and norepinephrine reuptake inhibitor that increases the amount of certain chemicals in the brain that help relieve depression and peripheral neuropathy. Neurofeedback training is a type of therapy that uses an electroencephalograph (EEG) and a computer software program to measure brain wave activity and may help teach patients with peripheral neuropathy (nerve damage) how to change their own brain waves to lower their feelings of neuropathy and help improve their overall quality of life. Giving duloxetine and neurofeedback training may work better in treating peripheral neuropathy caused by chemotherapy compared to duloxetine or neurofeedback training alone.

NCT ID: NCT04510532 Recruiting - Breast Cancer Clinical Trials

Early Detection of CMP in Patients With Breast Cancer Using Cardiac Magnetic Resonance

Start date: October 30, 2020
Phase:
Study type: Observational

Breast cancer is the most common cancers among women worldwide.Although chemotherapy and surgery have greatly improved the survival rate, most types of chemotherapy have been reported to have varying degrees of cardiotoxicity. The investigators will focus on the cardiotoxicity of pyrotinib and apatinib which belong to the new tyrosine kinase inhibitors in respective chemotherapy among more subjects.

NCT ID: NCT04472403 Recruiting - Clinical trials for Nasopharyngeal Carcinoma

Platinum Plus Low-dose Long-term Continuous Intravenous Infused 5-Fluorouracil in Metastatic Nasopharyngeal Carcinoma

Start date: November 26, 2019
Phase:
Study type: Observational

The treatment of distant metastasis is a key challenge for nasopharyngeal carcinoma because of poor outcomes, among which, chemotherapy is the cornerstone. However, many studies reported the use of different chemotherapy regimens to prolong the survival of metastatic nasopharyngeal carcinoma, while few of them focused on how to reduce the side effects of chemotherapy or improve the life quality of patients. Thus, we sought to find an efficient chemotherapy regimen with high tolerance according to the characteristics of chemotherapy drugs, that is, to explore the efficacy and safety of platinum plus 5-fluorouracil with continuous intravenous infusion at a low dose for a long term.