Thalidomide to Chemotherapy Related Nausea and Vomiting in Pancreatic Cancer

Trial Title: Thalidomide to Chemotherapy Related Nausea and Vomiting in Pancreatic Cancer

NCT ID: NCT06017284

Condition: Pancreatic Cancer Stage IV
Chemotherapy-induced Nausea and Vomiting

Conditions: Official terms:
Pancreatic Neoplasms
Nausea
Vomiting
Thalidomide
Paclitaxel
Gemcitabine

Conditions: Keywords:
chemotherapy
pancreatic cancer
Thalidomide
nausea
quality of life

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Intervention:

Intervention type: Drug
Intervention name: Thalidomide
Description: Thalidomide 100 mg/day, once a day, orally intake at night.
Arm group label: Chemotherapy + Thalidomide

Intervention type: Drug
Intervention name: Nab paclitaxel
Description: nab-paclitaxel (120 mg per square meter of body-surface area) on days 1, 8, and 15 every 4 weeks.
Arm group label: Chemotherapy
Arm group label: Chemotherapy + Thalidomide

Intervention type: Drug
Intervention name: Gemcitabine
Description: gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks.
Arm group label: Chemotherapy
Arm group label: Chemotherapy + Thalidomide

Intervention type: Drug
Intervention name: Placebo
Description: Placebo, 100 mg/day, once a day, orally intake at night.
Arm group label: Chemotherapy

Summary: The purpose of this study is to evaluate the efficacy of thalidomide on improving the quality of life for metastatic pancreatic cancer patients receiving gemcitabine and nab-paclitaxel chemotherapy.

Detailed description: Pancreatic cancer is a highly lethal malignancy with a 5-year survival less than 10%. Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage. Chemotherapy is one of the major treatments for advanced pancreatic cancer. The Metastatic Pancreatic Cancer Trial (MPACT) has confirmed the efficacy of gemcitabine combined with nab-paclitaxel as the first-line treatment to metastatic pancreatic cancer. However, the side-effects related to gemcitabine combined with nab-paclitaxel including nausea/vomiting, insomnia, fatigue, nausea, and malnutrition have impaired the tolerability of the regimen. Thalidomide is an oral medication used to treat a number of cancers (e.g. multiple myeloma), graft-versus-host disease, and many skin disorders (e.g. complications of leprosy such as skin lesions). It caused severe malformations in babies born to mothers taking the drug for morning sickness in the late 1950s and early 1960s. Thalidomide works on the immune system to reduce inflammation. Thalidomide may enhance the tolerability of chemotherapy by reducing nausea/vomiting, improving sleeping quality, alleviating pain, and thus improving quality of life for patients with pancreatic cancer. The purpose of this study is to evaluate the efficacy of Thalidomide on improving the quality of life for metastatic pancreatic cancer patients receiving gemcitabine and nab-paclitaxel chemotherapy. One hundred patients will be randomly assigned to the experimental group (gemcitabine combined with nab-paclitaxel, Thalidomide) or the control group (gemcitabine combined with nab-paclitaxel). Rate of nausea/vomiting, index of sleep quality, severity of pain, quality of life, and overall survival are measured every four weeks.

Criteria for eligibility:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Shanghai Cancer Center

Address:
City: Shanghai
Zip: 200032
Country: China

Status: Recruiting

Contact:
Last name: Ying Yang, MD

Phone: 86 21 64175590

Phone ext: 1307
Email: yangying@fudanpci.org

Start date: November 1, 2023

Completion date: November 30, 2026

Lead sponsor:
Agency: Fudan University
Agency class: Other

Source: Fudan University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06017284