The Effect of Vitamin C on Quality of Life of Terminal Cancer Patients

NCT03224572 | Unknown Phase 1

• 1 other identifier: 201702008MIPB
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study determines whether high dose vitamin C is effective for quality of life in terminal cancer patients.

Conditions

Vitamin C Deficiency

Keywords

vitamin C; quality of life; terminal cancer

Outcome Measures

Primary Outcomes (1)

• The improvement of quality of life (QOL)

  QOL measured by European Organization for Research and Treatment of cancer Quality of Life Questionnaire (EORTC QLQ)-C30

  6 months

Secondary Outcomes (1)

• Survival analysis

  6 months

Study Arms (2)

The study group

EXPERIMENTAL

The study group will receive intravenous high-dose vitamin C 30 gm in 500 ml normal saline in 1-hour infusion, once per week, and total 4-week treatment.

Drug: high-dose vitamin C 30gm; Other: normal saline

The control group

PLACEBO COMPARATOR

The control group will receive 500 ml normal saline in 1-hour infusion, once per week, and total 4-week treatment.

Other: normal saline

Interventions

high-dose vitamin C 30gm DRUG

High-dose vitamin C 30 gm in 500 ml normal saline, once per week, and total 4-week treatment.

Also known as: ascorbic acid 30 gm

The study group

normal saline OTHER

500ml normal saline, once per week, and total 4-week treatment

The control group; The study group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Terminal colon cancer patients without pleural effusions, who will not receive any curative radiotherapy or chemotherapy.

You may not qualify if:

• Renal metastasis or obstructive uropathy by radiology
• Nephrotic syndrome
• Creatinine over 1.5mg/dl
• Urolithasis
• Under other folk therapy or vitamin infusion therapy
• Those who can't exercise the right of consent
• Those who can't answer the questionaires
• Glucose-6-Phosphate Dehydrogenase Deficiency
• Severe lower leg edema or general edema

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Ascorbic Acid Deficiency

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Chin-Ying Chen, MD, MHSc

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chin-Ying Chen, MD, MHSc

CONTACT

886-2-23123456; crystalcychen@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment Randomized double-blinded controlled trial

Study Record Dates

• First Submitted: July 16, 2017
• First Posted: July 21, 2017
• Study Start: January 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 2, 2018

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)