MedPath

The effect of vitamin D supplementation compared to placebo on quality of life in stage II-III colorectal cancer patients undergoing adjuvant chemotherapy at Hasan Sadikin Hospital: A single-blind, randomized control trial.

Early Phase 1
Conditions
Colorectal Cancer
Registration Number
SLCTR/2024/016
Lead Sponsor
Andy
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
Not specified
Inclusion Criteria

1. Male and female patients diagnosed with colorectal cancer based on the WHO histopathological classification system.
2. All stage II-III colorectal cancer patients undergoing adjuvant chemotherapy at Hasan Sadikin Hospital from May 2024 to April 2025.
3. Patients above 18 years of age.

Exclusion Criteria

1. The patient has consumed vitamin D supplements in the last three months.
2. Allergy to vitamin D supplements.
3. The patient has a primary cancer other than colorectal cancer.
4. Patients with short bowel syndrome or patients undergoing gastric bypass surgery.
5. The patient regularly consumes phenobarbital, carbamazepine, dexamethasone, nifedipine, spironolactone, clotrimazole and rifampicin groups.
6. Patient with symptoms of genitourinary stones in the past year.
7. Patient is consuming a thiazide diuretic.
8. Patient with chronic non-infectious disease (liver failure and kidney failure, history of stroke, type I and II diabetes mellitus).
9. Patients with chronic infectious disease (infection lasts >6 months), such as HIV infection, tuberculosis, hepatitis C, HPV, et cetera.
10. Patients who are pregnant, breastfeeding or using oral contraceptives.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
evel of Vitamin D and EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30) score which contains 5 domains (Role, Physical, Cognitive, Emotional, and Social) [3- and 6-months post intervention]<br>
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath