Vitamin C to Chemotherapy Related Anemia in Pancreatic Cancer

NCT06018883 | Active Not Recruiting Phase 3

• 1 other identifier: PTCA199-3
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Pancreatic Adenocarcinoma

Keywords

ascorbate; anemia; quality of life; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Rate of anemia

  Rate of anemia after every cycle of chemotherapy

  At the end of Cycle 1 (each cycle is 28 days)

Secondary Outcomes (4)

• Rate of grade 3 neuropathy

  At the end of Cycle 1 (each cycle is 28 days)

• Change of numeric rating scale (NRS)

  At the end of Cycle 1 (each cycle is 28 days)

• Quality of life (QOL)

  At the end of Cycle 1 (each cycle is 28 days)

• Overall survival (OS)

  At the end of Cycle 1 (each cycle is 28 days)

Study Arms (2)

Ascorbate

EXPERIMENTAL

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; Drug: Nab paclitaxel; Drug: Gemcitabine

Control

OTHER

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; Drug: Gemcitabine

Interventions

Ascorbate DRUG

Vitamin C 900 mg/day, three times a day, orally.

Also known as: Vitamin C

Ascorbate

Nab paclitaxel DRUG

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

Also known as: Nab-paclitaxel

Ascorbate; Control

Gemcitabine DRUG

Gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks

Also known as: Gemcitabine Hydrochloride

Ascorbate; Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (4)

• Magri A, Germano G, Lorenzato A, Lamba S, Chila R, Montone M, Amodio V, Ceruti T, Sassi F, Arena S, Abrignani S, D'Incalci M, Zucchetti M, Di Nicolantonio F, Bardelli A. High-dose vitamin C enhances cancer immunotherapy. Sci Transl Med. 2020 Feb 26;12(532):eaay8707. doi: 10.1126/scitranslmed.aay8707.

  PMID: 32102933 BACKGROUND

• Drisko JA, Serrano OK, Spruce LR, Chen Q, Levine M. Treatment of pancreatic cancer with intravenous vitamin C: a case report. Anticancer Drugs. 2018 Apr;29(4):373-379. doi: 10.1097/CAD.0000000000000603.

  PMID: 29438178 BACKGROUND

• Cieslak JA, Cullen JJ. Treatment of Pancreatic Cancer with Pharmacological Ascorbate. Curr Pharm Biotechnol. 2015;16(9):759-70. doi: 10.2174/138920101609150715135921.

  PMID: 26201606 BACKGROUND

• Wang X, Zhu X, Liu Y, Liu H, Xiao Z, Luo G. Efficacy of vitamin C on chemotherapy-related anemia in pancreatic cancer: study protocol for a randomized controlled trial. Trials. 2024 Jul 29;25(1):512. doi: 10.1186/s13063-024-08345-w.

  PMID: 39075587 DERIVED

MeSH Terms

Conditions

Anemia

Interventions

Ascorbic Acid; Taxes; 130-nm albumin-bound paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Economics; Health Care Economics and Organizations; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Guopei Luo, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 31, 2023
• Study Start: August 20, 2023
• Primary Completion: August 15, 2025
• Study Completion (Estimated): August 15, 2026
• Last Updated: August 7, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)