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

Study Overview
=================
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.

Official Title
-----------------
The Effect of Vitamin C on Quality of Life of Terminal Cancer Patients

Conditions
-----------------
Vitamin C Deficiency

Intervention / Treatment
-----------------
* Drug: high-dose vitamin C 30gm
* Other: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment Randomized double-blinded controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The study group<br>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<br>* High-dose vitamin C 30 gm in 500 ml normal saline, once per week, and total 4-week treatment.<br>* Other names: ascorbic acid 30 gm;Other: normal saline<br>* 500ml normal saline, once per week, and total 4-week treatment<br>|
| Placebo Comparator: The control group<br>The control group will receive 500 ml normal saline in 1-hour infusion, once per week, and total 4-week treatment. | Other: normal saline<br>* 500ml normal saline, once per week, and total 4-week treatment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival analysis | death time of those who have completed the 4-week intervention | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin C, quality of life, terminal cancer