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

NCT ID: NCT03224572

Last Updated: 2018-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-31

Study Completion Date

2018-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Vitamin C Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment Randomized double-blinded controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
double-blinded

Study Groups

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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.

Group Type EXPERIMENTAL

high-dose vitamin C 30gm

Intervention Type DRUG

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

normal saline

Intervention Type OTHER

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

The control group

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

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type OTHER

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

Interventions

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high-dose vitamin C 30gm

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

Intervention Type DRUG

normal saline

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

Intervention Type OTHER

Other Intervention Names

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ascorbic acid 30 gm

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chin-Ying Chen, MD, MHSc

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Chin-Ying Chen, MD, MHSc

Role: CONTACT

886-2-23123456 ext. 66828

Facility Contacts

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Chin-Ying Chen

Role: primary

Other Identifiers

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201702008MIPB

Identifier Type: -

Identifier Source: org_study_id

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