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

December 28, 2017 updated by: National Taiwan University Hospital
This study determines whether high dose vitamin C is effective for quality of life in terminal cancer patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The improvement of quality of life (QOL)
Time Frame: 6 months
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
Time Frame: 6 months
death time of those who have completed the 4-week intervention
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Chin-Ying Chen, MD, MHSc, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2018

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

July 16, 2017

First Submitted That Met QC Criteria

July 18, 2017

First Posted (Actual)

July 21, 2017

Study Record Updates

Last Update Posted (Actual)

January 2, 2018

Last Update Submitted That Met QC Criteria

December 28, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201702008MIPB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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