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

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National Taiwan University

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Vitamin C Deficiency

Treatments

Other: normal saline
Drug: high-dose vitamin C 30gm

Study type

Interventional

Funder types

Other

Identifiers

NCT03224572
201702008MIPB

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups, including a placebo group

The study group
Experimental group
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.
Treatment:
Drug: high-dose vitamin C 30gm
Other: normal saline
The control group
Placebo Comparator group
Description:
The control group will receive 500 ml normal saline in 1-hour infusion, once per week, and total 4-week treatment.
Treatment:
Other: normal saline

Trial contacts and locations

1

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Central trial contact

Chin-Ying Chen, MD, MHSc

Data sourced from clinicaltrials.gov

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