Vitamin C to Quality of Life in Patients With Terminal Stage Pancreatic Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFudan University
About this trial
The purpose of this study is to evaluate the efficacy of vitamin C in improving the quality of life for metastatic pancreatic cancer patients who are resistant to 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
Active second primary malignancy or history of second primary malignancy.
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
Single group
Treatments tested in this trial
Ascorbate
DrugFor patients with baseline serum Vitamin C concentration \< 65 μmol/L, intravenous Vitamin C 10 g × 7 days, intravenous Vitamin C 4 g × 7 days, intravenous Vitamin C 2 g × 7 days, followed by continuously 900 mg/day, three times a day, orally. For patients with baseline serum Vitamin C concentration ≥ 65 μmol/L, continuously 900 mg/day, three times a day, orally.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: AscorbateExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
Rate of hand-foot skin reaction (HFSR)
Rate of HFSR after every cycle of treatment
Time frame
At the end of Cycle 1 (each cycle is 28 days)2
Change of numeric rating scale (NRS)
Change of NRS and the administration of analgesic drugs after every cycle of chemotherapy. 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)3
Rate of anemia
Rate of anemia after every cycle of treatment
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
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov