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Vitamin C to Chemotherapy Related Anemia in Pancreatic Cancer (PTCA199-3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06018883
Recruitment Status : Recruiting
First Posted : August 31, 2023
Last Update Posted : December 6, 2023
Sponsor:
Information provided by (Responsible Party):
Guopei Luo, Fudan University

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy of low-dose vitamin C on improving the quality of life for metastatic pancreatic cancer patients receiving gemcitabine and nab-paclitaxel chemotherapy.

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Adenocarcinoma Drug: Ascorbate Drug: Nab paclitaxel Drug: Gemcitabine 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. 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 anemia, hand/foot numbness, fatigue, nausea, and malnutrition have impaired the tolerability of the regimen.

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 enhance the tolerability of chemotherapy by increasing iron absorption, improving anemia, alleviating pain and hand/foot numbness, and thus improving quality of life for patients with pancreatic cancer.

The purpose of this study is to evaluate the efficacy of low-dose vitamin C 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, Vitamin C) or the control group (gemcitabine combined with nab-paclitaxel). Rate of anemia, rate of hand/foot numbness, severity of pain, quality of life, and overall survival are measured every four weeks.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin C to Chemotherapy Related Anemia in Pancreatic Cancer
Actual Study Start Date : August 20, 2023
Estimated Primary Completion Date : August 15, 2025
Estimated Study Completion Date : August 15, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Ascorbate
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. Vitamin C 900 mg/day, three times a day, orally.
 Drug: Ascorbate
Vitamin C 900 mg/day, three times a day, orally.
Other Name: Vitamin C

Drug: Nab paclitaxel
Nab-paclitaxel (120 mg per square meter of body-surface area) on days 1, 8, and 15 every 4 weeks
Other Name: Nab-paclitaxel

Drug: Gemcitabine
Gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks
Other Name: Gemcitabine Hydrochloride
Control
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.
 Drug: Nab paclitaxel
Nab-paclitaxel (120 mg per square meter of body-surface area) on days 1, 8, and 15 every 4 weeks
Other Name: Nab-paclitaxel

Drug: Gemcitabine
Gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks
Other Name: Gemcitabine Hydrochloride


Outcome Measures
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Primary Outcome Measures :
  1. Rate of anemia [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    Rate of anemia after every cycle of chemotherapy


Secondary Outcome Measures :
  1. Rate of grade 3 neuropathy [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    Rate of grade 3 neuropathy after every cycle of chemotherapy

  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. 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)

  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
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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.
  • 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.
  • Hemoglobin (Hgb) ≥ 8 g/dL.
  • 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.
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
  • 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).
  • Renal insufficiency or dialysis
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06018883


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

Locations
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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
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Principal Investigator: Guopei Luo, MD Fudan University
More Information
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Publications of Results:

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Responsible Party: Guopei Luo, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT06018883    
Other Study ID Numbers: PTCA199-3
First Posted: August 31, 2023    Key Record Dates
Last Update Posted: December 6, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Anemia
Hematologic Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Gemcitabine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites