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

Phase 1

• Conditions: Vitamin C Deficiency
• Interventions: Drug: high-dose vitamin C 30gm; Other: normal saline

• Registration Number: NCT03224572
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

Detailed Description

The investigator's project is a single medical center, randomized double- blinded trial. The target group is terminal cancer patients at Palliative care clinics. The experimental group will receive intravenous high-dose vitamin C 30 g in 500 ml normal saline in 1-hour infusion, once per week, and total 4-week treatment. The control group will receive 500 ml normal saline in 1-hour infusion, once per week, and total 4-week treatment. The primary outcome is the improvement of quality of life, measured by European Organization for Research and Treatment of cancer (EORTC). The secondary outcome is the survival analysis.The participants will be followed up weekly for 2 weeks, then bi-weekly for 6 months.

Study Timeline

• Status Verified: 2017-04
• Study First Submitted: 2017-07-16
• Study First Submitted QC: 2017-07-18
• Study First Posted: 2017-07-21
• Last Update Submitted: 2017-12-28
• Study Start: 2018-01
• Last Update Posted: 2018-01-02
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The improvement of quality of life (QOL)	6 months	QOL measured by European Organization for Research and Treatment of cancer Quality of Life Questionnaire (EORTC QLQ)-C30

Secondary Outcome Measures

Name	Time	Method
Survival analysis	6 months	death time of those who have completed the 4-week intervention

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan