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

Vitamin C Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03224572
• Other study ID #: 201702008MIPB
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: July 16, 2017
• Last updated: December 28, 2017
• Start date: January 2018
• Est. completion date: December 2018

Study information

• Verified date: April 2017
• Source: National Taiwan University Hospital
• Contact: Chin-Ying Chen, MD, MHSc
• Phone: 886-2-23123456
• Email: crystalcychen[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ascorbic Acid Deficiency
• Scurvy
• Vitamin C Deficiency

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Survival analysis	death time of those who have completed the 4-week intervention	6 months