A Phase 3 interventional study of Thalidomide and Nab paclitaxel in Pancreatic Cancer Stage IV and Chemotherapy-induced Nausea and Vomiting, sponsored by Fudan University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-11-24.
Sponsored by Fudan University · Phase 3, Interventional, and Treatment
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.
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's planned enrollment of 100 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
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Exclusion Criteria:
nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks. Thalidomide 100 mg/day, once a day, orally intake at night.
Drug: Thalidomide · Drug: Nab paclitaxel · Drug: Gemcitabine
nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks. placebo 100 mg/day, once a day, orally intake at night.
Drug: Nab paclitaxel · Drug: Gemcitabine · Drug: Placebo
Thalidomide 100 mg/day, once a day, orally intake at night.
nab-paclitaxel (120 mg per square meter of body-surface area) on days 1, 8, and 15 every 4 weeks.
gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks.
Placebo, 100 mg/day, once a day, orally intake at night.
Rate of nausea/vomiting
Rate of nausea/vomiting after every cycle of chemotherapy using the 4-point Likert scale. The range of scale is 0-3 and higher scores mean a worse outcome.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Pain numeric rating scale (NRS)
Change of pain numeric rating scale after every cycle of chemotherapy. The administration of analgesic drugs after every cycle of chemotherapy is recorded. The range of NRS scale is 0-10 and higher scores mean a worse outcome.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Quality of life (QOL)
Change of QOL after every cycle of chemotherapy assessed using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Sleep quality index
Sleep quality index after every cycle of chemotherapy is assessed using Pittsburgh sleep quality index (PSQI)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Overall survival (OS)
OS of subjects from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Plan to share: No
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