Vitamin DNCT06642441
Effect of Vitamin D Supplementation on Chemotherapy Side Effects After Adjuvant Chemotherapy for Breast Cancer
A study testing Chemotherapy + vitamin D2 and Chemotherapy in people with Vitamin D and Chemotherapy, run by Jiuda Zhao at 2 sites in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vitamin D, Chemotherapy, Breast Cancer
- What is being tested?
- Chemotherapy + vitamin D2 and Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 1 Dec 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Patients with adjuvant chemotherapy or combined targeted therapy.
- Life expectancy of at least 6 months.
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- No other uncontrolled benign diseases at the time of recruitment.
- All patients must have complete clinical medical records.
- Willingness to voluntarily sign an informed consent form.
Who cannot join
- 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.
- Vitamin D or calcium supplementation in the past 3 months.
- Presence of other tumors.
- Pregnant or lactating women.
- Individuals who do not wish to participate in the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
Qinghai University Affiliated Hospital
Xining, Qinghai, 810000
Jiuda Zhao, Dr, 869716230893, jiudazhao@126.com
- Recruiting
Qinghai University Affiliated Hospital
Xining, Qinghai, 810000
About this study
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
Read the detailed description
This is a parallel group, open-label randomized controlled trial to investigate the occurrence of side effects of vitamin D supplementation (VD) in adjuvant chemotherapy in patients with breast cancer. Both groups will receive standard adjuvant chemotherapy on day 1 and each subsequent cycle. In addition, vitamin D2 will be given randomly to both groups. Blood samples and imaging results were collected and analyzed before initiation of adjuvant chemotherapy and after every two cycles. The primary outcome to be documented was associated grade III or higher adverse events during adjuvant chemotherapy. Primary and secondary study findings and adverse events will be thoroughly evaluated.
- Conditions
- Vitamin D, Chemotherapy, Breast Cancer, Adverse Reaction
- Being tested
- Chemotherapy + vitamin D2, Chemotherapy
- Keywords
- Vitamin D, Breast Cancer, Adverse Reaction
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemotherapy + vitamin D2Drug
Before 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.
ChemotherapyDrug
Participants 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.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy + vitamin D2 | Experimental | Before the start of treatment and every 3 weeks thereafter, participants will receive a 10-milligram 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. Receives: Drug: Chemotherapy + vitamin D2 |
| chemotherapy | Other | Participants will receive a standard adjuvant chemotherapy regimen for each adjuvant chemotherapy cycle. The dosage of adjuvant chemotherapy drugs can be customized according to the clinical judgment of the doctor. Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and proportion of treatment-related adverse events
The occurrence of side effects between the two groups from the first to the last chemotherapy
Measured: 4-6months
Secondary outcomes (3)
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.
Measured: From the start of adjuvant therapy to 21 days after the last adjuvant therapy cycle.
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
Measured: From the start of adjuvant therapy to 21 days after the last adjuvant therapy cycle.
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
Measured: From the start of adjuvant therapy to 21 days after the last adjuvant therapy cycle.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Dec 2024
- Primary completion31 Jan 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin DStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiuda Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiuda Zhao, Affiliated Hospital of Qinghai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642441
- Sponsor's protocol ID
- AHQU-2024004
- Status last verified
- Oct 2024
- First submitted
- 13 Oct 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Supplementation on Chemotherapy Side Effects After Adjuvant Chemotherapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT06642441
- Acronym / sponsor ID
- AHQU-2024004
- Conditions
- Vitamin D, Chemotherapy, Breast Cancer, Adverse Reaction
- Keywords
- Vitamin D, Breast Cancer, Adverse Reaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jiuda ZhaoUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is a parallel group, open-label randomized controlled trial to investigate the occurrence of side effects of vitamin D supplementation (VD) in adjuvant chemotherapy in patients with breast cancer. Both groups will receive standard adjuvant chemotherapy on day 1 and each subsequent cycle. In addition, vitamin D2 will be given randomly to both groups. Blood samples and imaging results were collected and analyzed before initiation of adjuvant chemotherapy and after every two cycles. The primary outcome to be documented was associated grade III or higher adverse events during adjuvant chemotherapy. Primary and secondary study findings and adverse events will be thoroughly evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy + vitamin D2 | Experimental | Drug: Chemotherapy + vitamin D2Before the start of treatment and every 3 weeks thereafter, participants will receive a 10-milligram 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 | Other | Drug: ChemotherapyParticipants will receive a standard adjuvant chemotherapy regimen for each adjuvant chemotherapy cycle. The dosage of adjuvant chemotherapy drugs can be customized according to the clinical judgment of the doctor. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Patients with adjuvant chemotherapy or combined targeted therapy.
Key exclusion criteria (8 listed)
- 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.
- Vitamin D or calcium supplementation in the past 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chemotherapy + vitamin D2Before 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. | Drug | Chemotherapy + vitamin D2 |
| ChemotherapyParticipants 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. | Drug | chemotherapy |
Primary outcome
Incidence and proportion of treatment-related adverse events
Time frame: 4-6months
The occurrence of side effects between the two groups from the first to the last chemotherapy
3 secondary outcomes
Evaluation of side effects associated with adjuvant therapy (CTCAE v5.0)
Time frame: From the start of adjuvant therapy to 21 days after the last adjuvant therapy cycle.
Assessment of side effects associated with adjuvant therapy (EQ-5D Health Status Scale)
Time frame: From the start of adjuvant therapy to 21 days after the last adjuvant therapy cycle.
Assessment of side effects associated with adjuvant therapy (Abbreviated Fatigue Scale)
Time frame: From the start of adjuvant therapy to 21 days after the last adjuvant therapy cycle.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chemotherapy + vitamin D2 and Chemotherapy in people with Vitamin D and Chemotherapy, run by Jiuda Zhao at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiuda Zhao (869716230893, jiudazhao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and proportion of treatment-related adverse events (time frame: 4-6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.