The Effect of Vitamin C on Quality of Life of Terminal Cancer Patients
Primary Purpose
Vitamin C Deficiency
Status
Unknown status
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
high-dose vitamin C 30gm
normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin C Deficiency focused on measuring vitamin C, quality of life, terminal cancer
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
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
The study group
The control group
Arm Description
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 will receive 500 ml normal saline in 1-hour infusion, once per week, and total 4-week treatment.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Survival analysis
death time of those who have completed the 4-week intervention
Full Information
NCT ID
NCT03224572
First Posted
July 16, 2017
Last Updated
December 28, 2017
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03224572
Brief Title
The Effect of Vitamin C on Quality of Life of Terminal Cancer Patients
Official Title
The Effect of Vitamin C on Quality of Life of Terminal Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2018 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin C Deficiency
Keywords
vitamin C, quality of life, terminal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment Randomized double-blinded controlled trial
Masking
ParticipantCare Provider
Masking Description
double-blinded
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The study group
Arm Type
Experimental
Arm Description
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.
Arm Title
The control group
Arm Type
Placebo Comparator
Arm Description
The control group will receive 500 ml normal saline in 1-hour infusion, once per week, and total 4-week treatment.
Intervention Type
Drug
Intervention Name(s)
high-dose vitamin C 30gm
Other Intervention Name(s)
ascorbic acid 30 gm
Intervention Description
High-dose vitamin C 30 gm in 500 ml normal saline, once per week, and total 4-week treatment.
Intervention Type
Other
Intervention Name(s)
normal saline
Intervention Description
500ml normal saline, once per week, and total 4-week treatment
Primary Outcome Measure Information:
Title
The improvement of quality of life (QOL)
Description
QOL measured by European Organization for Research and Treatment of cancer Quality of Life Questionnaire (EORTC QLQ)-C30
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Survival analysis
Description
death time of those who have completed the 4-week intervention
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chin-Ying Chen, MD, MHSc
Phone
886-2-23123456
Ext
66828
Email
crystalcychen@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chin-Ying Chen, MD, MHSc
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chin-Ying Chen
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Vitamin C on Quality of Life of Terminal Cancer Patients
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