Vitamin C to Quality of Life in Patients With Terminal Stage Pancreatic Cancer (PTCA199-4)

• ClinicalTrials.gov Identifier: NCT06018896
• Recruitment Status: Recruiting
• First Posted: August 31, 2023
• Last Update Posted: August 31, 2023
• Sponsor: Fudan University
• Information provided by (Responsible Party): Guopei Luo, Fudan University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Metastatic Pancreatic Cancer; Terminal Cancer	Drug: Ascorbate	Phase 3

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. In 2011, a trial has shown that oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) was associated with a survival advantage but had increased toxicity. In 2013, 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 chemotherapy including anemia, hand/foot numbness, fatigue, nausea, and malnutrition have impaired the quality of life for patients.

Vitamin C, also called ascorbate, is an essential nutrient for the human body. It modulates metabolism, immune reaction, collagen synthesis, and iron absorption. Some studies have shown that high-dose intravenous Vitamin C may be effective against various types of cancer. Meanwhile, medium or low dose of Vitamin C may increase iron absorption, improve anemia, alleviate pain and hand/foot numbness, and thus improve the quality of life for patients with terminal stage pancreatic cancer.

The purpose of this study is to evaluate the efficacy of vitamin C on improving the quality of life for metastatic pancreatic cancer patients who are resistant to two lines of systemic chemotherapy, including gemcitabine based, fluorouracil based, or other regimen. Twenty patients who have tumor progression after receiving two lines of chemotherapy will be recruited. These patients will receive Vitamin C and the dosage is based on the concentration of baseline serum Vitamin C concentration. Quality of life, rate of hand/foot numbness, severity of pain, rate of anemia, and overall survival are measured every four weeks.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Vitamin C to Quality of Life in Patients With Terminal Stage Pancreatic Cancer
• Actual Study Start Date: August 25, 2023
• Estimated Primary Completion Date: August 15, 2025
• Estimated Study Completion Date: August 15, 2026

Arms and Interventions

Arm

Intervention/treatment

Experimental: Ascorbate; For 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.

Drug: Ascorbate; For 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.; Other Name: Vitamin C

Outcome Measures

Primary Outcome Measures :

1. Quality of life (QOL) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
   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)

Secondary Outcome Measures :

1. Rate of hand-foot skin reaction (HFSR) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
   Rate of HFSR after every cycle of treatment
2. Change of numeric rating scale (NRS) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
   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.
3. Rate of anemia [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
   Rate of anemia after every cycle of treatment
4. Overall survival (OS) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.
• Tumor progression after two lines of chemotherapy.
• Adequate organ performance based on laboratory blood tests.
• Presence of at least of one measurable lesion in agreement to Response Evaluation Criteria in Solid Tumours (RECIST) criteria.
• The expected survival ≥ 1 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:

• 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.
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
• Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results.
• Renal insufficiency or dialysis
• 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.

Contacts and Locations

Contacts

Contact: Ying Yang, MD; 86 21 64175590 ext 1307; yangying@fudanpci.org

Locations

China, Shanghai

Shanghai Cancer Center; Recruiting

Shanghai, Shanghai, China, 200032

Contact: Ying Yang, MD 86 21 64175590 ext 1307 yangying@fudanpci.org

Sponsors and Collaborators

Fudan University

Investigators

• Principal Investigator: Guopei Luo, MD; Fudan University

More Information

• Responsible Party: Guopei Luo, Professor, Fudan University
• ClinicalTrials.gov Identifier: NCT06018896
• Other Study ID Numbers: PTCA199-4
• First Posted: August 31, 2023
• Last Update Posted: August 31, 2023
• Last Verified: August 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Guopei Luo, Fudan University:

ascorbate; anemia; quality of life; chemotherapy

Additional relevant MeSH terms:

Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases