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Chemotherapy clinical trials

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NCT ID: NCT05840562 Not yet recruiting - Clinical trials for Chemotherapy-induced Peripheral Neuropathy

Capsaicin 179 mg Patch Versus Oral Duloxetine in Patients With Chemotherapy-induced Peripheral Neuropathy

CAPNEUCHIM
Start date: September 2023
Phase: Phase 3
Study type: Interventional

Chemotherapy induced peripheral neuropathy (CIPN) is a frequent and disabling complication of systemic chemotherapy, particularly with oxaliplatin or taxanes. The incidence of CIPN is variable but approximately 30-40% of patients treated with neurotoxic chemotherapy agents develop CIPN after long-term use of taxanes or oxaliplatin. This CIPN is essentially a sensory peripheral neuropathy with pain manifested by unpleasant symptoms such as numbness, tingling, and less frequently shooting/burning pain. These symptoms spread proximally to affect both lower and upper extremities in a characteristic "stocking and glove" distribution. Many symptoms of CIPN may resolve completely for some patients. However, CIPN is only partly reversible for most. In the worst instances, it does not appear to be reversible at all and can even increase over time. CIPN is difficult to manage. Only duloxetine is recommended, based on the positive result of a randomized phase III double-blind placebo-controlled crossover trial. The use of duloxetine resulted in a greater reduction in pain and was effective in decreasing numbness and tingling in the feet. But, systemic antidepressants are often associated with toxicities and patients often refuse or abandon the treatment. Capsaicin inhibits neural transmission in sensory axons and has been proven as effective on the intensity of pain for post-herpetic neuralgia and human immunodeficiency virus-associated neuropathy. Efficacy appears at one month and persists for at least 2 months. Only a few studies focused on the efficacy of capsaicin 179 mg patch on the intensity of CIPN-induced pain. These non-randomized studies show that more than 50% of patients have a reduction in pain intensity of more than 30%. Until now, no clinical trial has compared the efficacy of the capsaicin 179 mg patch with duloxetine. Accordingly, this open-label phase 3, randomized, multicenter trial, will compare efficacy and safety of capsaicin patch with oral duloxetine on painful CIPN persisting more than 3 months after the end of the responsible chemotherapy.

NCT ID: NCT05838638 Recruiting - Neoplasms Clinical Trials

Serious Gaming for Chemotherapy-induced Nausea and Vomiting

Start date: June 9, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the effectiveness of a technology-based intervention for managing nausea and vomiting in older adults with cancer. Participants will be randomized to either an intervention or control group. Outcomes such as symptom severity, quality of life, and resource use will be examined.

NCT ID: NCT05829967 Not yet recruiting - Clinical trials for Chemotherapy-induced Peripheral Neuropathy

CIPN and it's Impact on Quality of Life in Patients Receiving Platinum and Taxanes

Start date: June 1, 2023
Phase:
Study type: Observational

Neuropathies are a major cause of moderate to severe impairments in cancer patients. Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most frequent side effects caused by antineoplastic agents, with a prevalence from 19% to over 85%.

NCT ID: NCT05825443 Recruiting - Immunotherapy Clinical Trials

Adjuvant Chemotherapy Combined With Camrelizumab for ⅡA -ⅢA NSCLC Patients

PANORAMA
Start date: April 10, 2023
Phase: Phase 2
Study type: Interventional

Postoperative adjuvant chemotherapy followed by immunotherapy for non-small cell lung cancer has become a new treatment recommendation, but there are still many clinical problems to be solved in postoperative adjuvant immunotherapy. This study aims to explore the efficacy and safety of adjuvant chemotherapy combined with immunotherapy in patients with stage IIA-IIIA non-small cell lung cancer after surgery. Patients who meet the protocol and sign the informed consent form received 4 cycles of chemotherapy combined with camrelizumab, followed by maintenance with camrelizumab until one year or the disease progressed or unacceptable toxicity.

NCT ID: NCT05821452 Not yet recruiting - Chemotherapy Clinical Trials

Immunotherapy Plus Chemotherapy vs. Chemoradiotherapy for Thoracic Squamous Esophageal Carcinoma

Start date: May 25, 2023
Phase: Phase 2
Study type: Interventional

The investigators conducted a phase II, prospective, two-arm clinical study to explore the efficacy of Camrelizumab combined with chemotherapy versus chemoradiotherapy for conversion therapy of potentially resectable advanced esophageal squamous cell carcinoma. This study will provide more evidence for conversion treatment of initially unresectable locally advanced esophageal squamous cell carcinoma and contribute to the development of treatment guidelines for esophageal cancer.

NCT ID: NCT05817201 Recruiting - Esophageal Cancer Clinical Trials

Toripalimab Plus Radiotherapy for Elderly Esophageal Cancer Patients Treated With Non-chemotherapy Strategy

Start date: July 1, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this clinical trial is to explore the therapeutic efficacy of immune checkpoint inhibitors combined with radical radiotherapy in elderly patients with esophageal cancer.

NCT ID: NCT05805800 Recruiting - Clinical trials for Chemotherapy-induced Nausea and Vomiting

Olanzapine and 5-HT3 With or Without Dexamethasone to Prevent CINV

Start date: March 15, 2023
Phase: Phase 3
Study type: Interventional

Nausea and vomiting caused by chemotherapy are considered by patients as the main side effects of cancer treatment, which affect the quality of treatment and life.At present, NCCN guidelines have recommended three or four drug regimens for highly emetic chemotherapy (HEC) to prevent vomiting, all containing dexamethasone.However, its side effects such as moderate to severe insomnia, hyperglycemia, dyspepsia, upper abdominal discomfort, irritability, increased appetite, weight gain and acne are gathering increasing concerns.For certain patients, the use of dexamethasone should be avoided.Analysis shows that olanzapine can replace the effect of dexamethasone.Hence, the investigators initiated this prospective, multi-center, phase III study to validate the dexamethasone-free protocol: removing dexamethasone from a three drug regimen containing olanzapine, dexamethasone, and 5-HT3RA.

NCT ID: NCT05792228 Completed - Clinical trials for Squamous Cell Carcinoma of Head and Neck

A Standardized Intervention to Improve the Management of Chemotherapy-induced Nausea and Vomiting

Start date: April 2, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to investigate the effect of a nurse-led standardized intervention on chemotherapy induced nausea and vomiting (CINV) in patients with head and neck squamous cell carcinoma. The main questions it aims to answer are: (1) what's the best practice to enhance the management of CINV; (2) how's the effect of the nurse-led standardized intervention on CINV in the patients treated with cisplatin-based chemotherapy. Participants in the intervention group will receive evidence-based, nurse-led standardized management of CINV, including nurse-led risk assessment, education on prevention and control of CINV, antiemetics following guidelines, dietary strategies, relaxation therapy, and follow up. Participants in the control group will receive routine care of CINV. The incidence and occurrence degree of CINV and its influence on patients' quality of life will be compared between the two groups.

NCT ID: NCT05786599 Not yet recruiting - Clinical trials for Chemotherapy-induced Peripheral Neuropathy

Methadone to Treat Painful Chemotherapy Induced Peripheral Neuropathy

METACIN
Start date: May 2024
Phase: Phase 2/Phase 3
Study type: Interventional

Chemotherapy induced peripheral neuropathy (CIPN) or nerve pain, is a painful and debilitating complication which can chronically affect up to 70% of patients who receive chemotherapy. It causes "glove-and-stocking" distribution of nerve-pain, weakness, and other debilitating symptoms. This can affect patient's quality of life, function, ability to tolerate chemotherapy, and return to work. Duloxetine is the only recommended medication to reduce the painful symptoms and consequences of CIPN by national and international groups such as the American Society of Clinical Oncology. However, studies indicate it only has modest effect; for example, the largest study shows it only reduces pain by 0.73/10 points compared to placebo. Another promising medication in theory and practice is methadone. It is a commonly used and well-studied opioid with unique attributes which allows it to treat non-cancer and cancer associated nerve-pain with better efficacy when compared to other opioids. Furthermore, patients appear to develop less tolerance to methadone over time when compared to other opioids; this is helpful as many develop long-term CIPN and may greatly benefit from long-term pain medication. Therefore, if a patient requires chronic opioids to reduce the painful symptoms of CIPN, one that develops less tolerance is invaluable. Despite the promising role for methadone to treat CIPN, it has not been studied to treat this condition. Therefore, methadone may never be considered by prescribers to reduce the painful symptoms of CIPN. This study is a randomized controlled trial to assess the efficacy of methadone compared to duloxetine to treat painful CIPN. Participants will be randomized to receive either methadone or duloxetine regularly for 5 weeks. Methadone and duloxetine will be placed in indistinguishable capsules, so the participant and assessor are not aware of their treatment. They will be followed virtually or in-person weekly for 5 weeks where they will answer brief questionnaires detailing the effect of their treatment on their pain and their dose will increase weekly as tolerated until their pain is controlled or its the end of the study. This study would be critical in assessing the efficacy of a very promising medication to reduce the painful symptoms of CIPN: a debilitating disorder with otherwise few treatment options.

NCT ID: NCT05781425 Recruiting - Clinical trials for Chemotherapy-induced Peripheral Neuropathy

Prediction of Getting Peripheral Neuropathy in Patients Treated With Bortezomib?

NFL-BIOPAIN
Start date: May 12, 2023
Phase:
Study type: Observational

Investigation of which patients treated with bortezomib that have increased risk of developing peripheral neuropathy.