Vitamin C to Quality of Life in Patients With Terminal Stage Pancreatic Cancer

NCT06018896 | Recruiting Phase 2

• 1 other identifier: PTCA199-4
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Pancreatic Cancer; Terminal Cancer

Keywords

ascorbate; anemia; quality of life; chemotherapy

Outcome Measures

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)

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

Secondary Outcomes (4)

• Rate of hand-foot skin reaction (HFSR)

  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)

• Rate of anemia

  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 (1)

Ascorbate

EXPERIMENTAL

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

Interventions

Ascorbate DRUG

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.

Also known as: Vitamin C

Ascorbate

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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Anemia

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Guopei Luo, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Yang, MD

CONTACT

86 21 64175590; yangying@fudanpci.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• 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 25, 2023
• Primary Completion: August 15, 2025
• Study Completion (Estimated): August 15, 2026
• Last Updated: June 6, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)