Thalidomide to Chemotherapy Related Nausea and Vomiting in Pancreatic Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFudan University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Thalidomide
DrugThalidomide 100 mg/day, once a day, orally intake at night.
Nab paclitaxel
Drugnab-paclitaxel (120 mg per square meter of body-surface area) on days 1, 8, and 15 every 4 weeks.
Gemcitabine
Druggemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks.
Placebo
DrugPlacebo, 100 mg/day, once a day, orally intake at night.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Chemotherapy + ThalidomideExperimental treatment 3 interventions
Group B: ChemotherapyActive comparator 3 interventions
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov