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NCT ID: NCT03032718 Recruiting - Clinical trials for Chemotherapy-induced Peripheral Neuropathy

Whole-body Vibration Training to Reduce the Symptoms of Chemotherapy-induced Peripheral Neuropathy

VANISH
Start date: March 1, 2017
Phase: N/A
Study type: Interventional

Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and clinically meaningful side effect of cancer treatment. It is induced by neurotoxic chemotherapeutic agents, causing severe sensory and/or motor deficits such as pain, altered sensation, reduced or absent reflexes, muscle weakness, reduced balance control, insecure gait, and higher risk of falling. It is associated with significant disability and poor recovery, not only reducing patients' autonomy and quality of life but also limiting medical cancer therapy, which subsequently may affect the clinical outcome and compromise survival. To date, CIPN cannot be prevented and approved and effective treatment options are lacking. Promising results regarding CIPN have recently been achieved with exercise. Own preliminary work revealed that patients profit from sensorimotor training (SMT), experiencing significant relief from CIPN induced symptoms. In a pilot study we therefore also evaluated whole body vibration training, a further neuromuscular stimulating exercise intervention. Results suggest that whole body vibration (WBV) is not only feasible and safe for neuropathic cancer patients but can attenuate motor and sensory deficits. We therefore propose a two-armed, multicenter, randomized controlled trial (RCT with a follow-up period), including 44 patients with neurologically confirmed CIPN, in order to evaluate the effects of WBV on the relevant symptoms of CIPN. Primary endpoint is the patient reported reduction of CIPN-related symptoms (FACT-GOG-Ntx). Secondary endpoints will include compound muscle action potentials, distal motor latency, conduction velocity, and F-waves from the tibial and peroneal nerve as well as antidromic sensory nerve conduction studies of the sural nerve, feasibility, non-invasive electromyographic (EMG) activity of mm. tibialis anterior, soleus, gastrocnemius medialis, rectus femoris, vastus medialis and biceps femoris, peripheral deep sensitivity, proprioception, balance control as well as pain, quality of life and the level of physical activity. Patients will be assessed before and after a 12 week intervention and again after 12 weeks of follow-up. Interim tests will be performed 6 weeks into the intervention as well as every 3 weeks during the follow-up. We hypothesize that individually tailored whole body vibration training will reduce relevant symptoms of CIPN. Our results could contribute to improve supportive care in oncology, thereby enhancing patients' quality of life and coincidentally enabling the optimal medical therapy.

NCT ID: NCT03008213 Terminated - Clinical trials for Chemotherapy Induced Nausea Vomiting

Combination of Netupitant and Palonosetron (Akynzeo®) in the Treatment of Refractory CINV

CINV
Start date: January 2017
Phase: Phase 2
Study type: Interventional

Prevention and control of Chemotherapy-Induced Nausea and Vomiting (CINV) are most important in treatment of cancer patients. CINV is one of the most distressing severe side effects of cancer treatment and can have a significant impact on a patient's quality of life. The chemotherapy agents that cause the worst degree of nausea and vomiting are categorized into two groups: moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy (HEC). Nausea and vomiting that occurs within the first day of the administration of chemotherapy agents is considered acute CINV, while nausea and vomiting following 24 hours of the administration of chemotherapy agents is considered delayed CINV. Refractory CINV occurs when patients develop CINV during subsequent cycles of chemotherapy when drugs preventing vomiting and nausea (antiemetic prophylaxis) has not been successful in controlling CINV in earlier cycles. The purpose of this study is to assess the efficacy of Akynzeo in the treatment of refractory CINV

NCT ID: NCT02989129 Withdrawn - Clinical trials for Chemotherapy Induced Neuropathic Pain

Trial of Quercetin in the Treatment and Prevention of Chemotherapy-induced Neuropathic Pain in Cancer Patients

Start date: April 2018
Phase: Early Phase 1
Study type: Interventional

The goal of this clinical research study is to learn about the effectiveness of quercetin in treating and preventing CINP. Researchers also want to learn if quercetin has an effect on participant's quality of life.

NCT ID: NCT02982694 Terminated - ColoRectal Cancer Clinical Trials

Study With Atezolizumab Plus Bevacizumab in Patients With Chemotherapy Resistant, MSI-like, Colorectal Cancer

Start date: November 24, 2017
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to determine the anti-tumor activity, as measured by overall response rate (ORR) of atezolizumab in combination with bevacizumab in patients with chemotherapy resistant CRC and positivity for MSI-like molecular signature. This is an international, open-label single arm (non-randomized), one-stage phase II trial.

NCT ID: NCT02970643 Enrolling by invitation - Clinical trials for Chemotherapy-induced Nausea and Vomiting

Proof-of-Concept Trial of Palonosetron and Olanzapine Without Dexamethasone for the Prevention of CIN

Start date: July 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether Palonosetron and Olanzapine without dexamethasone for the Prevention of moderate risk Chemotherapy-Induced Nausea and vomiting.

NCT ID: NCT02959541 Active, not recruiting - Colon Cancer Clinical Trials

PK/PD Investigation of Calciumfolinat in Blood, Tumor and Adjacent Mucosa in Patient With Colon Cancer

Start date: September 2016
Phase: N/A
Study type: Interventional

This is an open randomized single site Pharmacokinetic and Pharmacodynamic study,of Calciumfolinat 60 mg/m², 200 mg/m² or 500 mg/ m² in blood, tumor and adjacent mucosa from patients with colon cancer

NCT ID: NCT02933099 Not yet recruiting - Clinical trials for Chemotherapy-induced Nausea and Vomiting

Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting

CINV
Start date: October 2016
Phase: Phase 3
Study type: Interventional

To compare the antiemetic combination of palonosetron, dexamethasone, and aprepitant (PDA) with antiemetic combination of palonosetron and dexamethasone (PD) in nasopharyngeal carcinoma patients receiving docetaxel, cisplatin, and 5-FU based chemotherapy.

NCT ID: NCT02909478 Completed - Colorectal Cancer Clinical Trials

Aprepitant Without Steroid in Preventing Chemotherapy-induced Nausea and Vomiting in Patients With Colorectal Cancer

Start date: September 1, 2017
Phase: Phase 3
Study type: Interventional

Addition of aprepitant, an NK1 receptor antagonist to a 5-HT3 receptor antagonist and dexamethasone regimen was shown to be effective for prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy (MEC). Little is known about the efficacy of aprepitant when used without dexamethasone. Dexamethasone is widely used to prevent both acute and delayed nausea and vomiting induced by chemotherapy. However, multi-period use of dexamethasone could be associated with side effect, such as hyperglycemia, dyspepsia and insomnia. This randomized phase III trial studies antiemetic therapy with aprepitant and tropisetron to see how well they work compared to dexamethasone plus tropisetron in preventing chemotherapy-induced nausea and vomiting in patients with colorectal cancer receiving FOLFOX(oxaliplatin, leuvovorin and 5-fluorouracil) chemotherapy.

NCT ID: NCT02873520 Recruiting - Chemotherapy Clinical Trials

Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Gastric Cancer

Start date: August 2016
Phase: Phase 1/Phase 2
Study type: Interventional

To evaluate the safety and effectiveness of cell therapy using Precision Cells to treat Advanced Gastric Cancer. Eligibility: Individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Gastric Cancer.

NCT ID: NCT02873416 Recruiting - Chemotherapy Clinical Trials

Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Lung Cancer

Start date: August 2016
Phase: Phase 1/Phase 2
Study type: Interventional

To evaluate the safety and effectiveness of cell therapy using Precision Cell Immunotherapy to treat Advanced Lung Cancer. Eligibility: Individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Lung Cancer.