Effect of Vitamin D Supplementation on Chemotherapy Side Effects After Adjuvant Chemotherapy for Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJiuda Zhao
About this trial
This randomized controlled Phase III trial was designed to evaluate the effect of vitamin D supplementation (VD) on chemotherapy side effects following adjuvant chemotherapy in breast cancer
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 80 years, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Primary diagnosis of breast cancer confirmed by preoperative pathological examination.
Serum 25(OH)D levels less than 20 ng/ml (50 nmol/L).
Patients who have not previously received chemotherapy and who plan to undergo at least 4 cycles of
Disqualifiers
History of invasive breast cancer.
Prior systemic treatment for the treatment or prevention of breast cancer.
Known allergic reactions to vitamin D or calcium compounds.
Comorbidities that may affect vitamin D or calcium balance or bone health.
Trial design
Design model
Parallel
Treatments tested in this trial
Chemotherapy + vitamin D2
DrugBefore the start of treatment and every 3 weeks thereafter, participants will receive a 10 mg dose of vitamin D2 injection until adjuvant chemotherapy is completed. They will receive a standard adjuvant chemotherapy regimen, which includes 10 mg of vitamin D2 injections per cycle during treatment. The dosage of adjuvant chemotherapy drugs can be customized according to the clinical judgment of the doctor.
Chemotherapy
DrugParticipants will receive a standard adjuvant chemotherapy treatment regimen for each adjuvant chemotherapy cycle. The dosage of adjuvant chemotherapy drugs can be customized according to the clinical judgment of the doctor.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Chemotherapy + vitamin D2Experimental treatment 1 intervention
Group B: chemotherapyOther 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and proportion of treatment-related adverse events
The occurrence of side effects between the two groups from the first to the last chemotherapy
Time frame
4-6monthsSecondary outcomes
1
Evaluation of side effects associated with adjuvant therapy (CTCAE v5.0)
Side effects of adjuvant therapy were evaluated according to CTCAE v5.0 criteria. CTCAE v5.0 was used to evaluate the degree of adverse events after patients received adjuvant chemotherapy. The level of adverse events was divided into 1-5 grades. The higher the level, the more serious the degree of adverse reactions after patients received chemotherapy, and active intervention was required.
Time frame
From the start of adjuvant therapy to 21 days after the last adjuvant therapy cycle.2
Assessment of side effects associated with adjuvant therapy (EQ-5D Health Status Scale)
Side effects of adjuvant therapy will be assessed according to the EQ-5D Health Status Scale criteria. The EQ-5D health status scale was used to evaluate the health status of patients after chemotherapy. The scale score was between 0 and 1, and the higher the scale score was, the better the health status of patients was reflected
Time frame
From the start of adjuvant therapy to 21 days after the last adjuvant therapy cycle.3
Assessment of side effects associated with adjuvant therapy (Abbreviated Fatigue Scale)
The side effects of adjuvant therapy will be assessed according to the Concise Fatigue Scale (BFI) criteria, with a score between 0 and 10, with a lower score indicating less fatigue
Time frame
From the start of adjuvant therapy to 21 days after the last adjuvant therapy cycle.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jiuda Zhao
Lead sponsor
Affiliated Hospital of Qinghai University
Sponsor institution
Source ClinicalTrials.gov