Using Thalidomide to Reduce Nausea from Chemotherapy in Pancreatic Cancer
Thalidomide to Chemotherapy Related Nausea and Vomiting in Pancreatic Cancer
This study is testing if thalidomide can help reduce nausea and improve the quality of life for people with pancreatic cancer who are receiving chemotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06017284 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of thalidomide in improving the quality of life for patients with metastatic pancreatic cancer undergoing chemotherapy with gemcitabine and nab-paclitaxel. The trial aims to address the common side effects of chemotherapy, particularly nausea and vomiting, which significantly impact patient comfort and treatment adherence. One hundred participants will be randomly assigned to receive either thalidomide or a placebo alongside their chemotherapy regimen. The study will assess the impact of thalidomide on nausea, vomiting, and overall quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with histologically confirmed metastatic pancreatic adenocarcinoma and an ECOG performance status of 0-2.
Not a fit: Patients who have previously received anti-tumor therapy or have non-adenocarcinoma pancreatic diagnoses will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance the quality of life for patients suffering from chemotherapy-induced nausea and vomiting.
How similar studies have performed: While thalidomide has been used successfully in other cancer treatments, this specific application for chemotherapy-induced nausea in pancreatic cancer is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to understand and the willingness to sign a written informed consent document. * Age ≥ 18 years and ≤ 80 years. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Histologically or cytologically confirmed metastatic pancreas adenocarcinoma. * Adequate organ performance based on laboratory blood tests. * Presence of at least of one measurable lesion in agreement to Response Evaluation Criteria in Solid Tumors (RECIST) criteria. * The expected survival ≥ 3 months. * Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Exclusion Criteria: * Patients who have received any form of anti-tumor therapy. * The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas. * Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc. * Pregnant or nursing women. * Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results, including active opportunistic infections or advanced (severe) infections, and diabetes that cannot be controlled after adequate clinical anti-hyperglycemia treatment according to guidelines, uncontrollable hypertension, cardiovascular disease (Class III or IV heart failure as defined by the New York Heart Association classification, congestive heart failure (CHF), myocardial infarction in the past 6 months , unstable arrhythmia or unstable angina, cerebral infarction within 3 months, etc). * History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, nab-paclitaxel, or other agents used in the study. * Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment. * Patients who are unwilling or unable to comply with study procedures.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Guopei Luo, MD — Fudan University
- Study coordinator: Ying Yang, MD
- Email: yangying@fudanpci.org
- Phone: 86 64175590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.