Using Thalidomide to Reduce Nausea from Chemotherapy in Pancreatic Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.