Peripheral Neuropathic PainPhase 2NCT06596122
Vitamin D Supplementation in Breast Cancer Patients
A Phase 2 study testing Vitamin D (Cholecalciferol ) in people with Peripheral Neuropathic Pain, run by Abdelrahman Mahmoud at 1 site in Egypt.
Trial summary
It is a randomized clinical trial aimed at exploring the neuroprotective effect of vitamin D3 (Cholecalciferol) supplementation in conjunction with paclitaxel-based chemotherapy among breast cancer patients with vitamin D insufficiency or deficiency. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Peripheral Neuropathic Pain
- What is being tested?
- Vitamin D (Cholecalciferol )
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2024to 30 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female aged 18 to 65 years old.
- Histologically confirmed breast cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2 [21] [22].
- All patients should fulfill the criteria of the initiation of taxane-based chemotherapy such as absolute neutrophil count (ANC) \> 1,500/mcL, platelets \> 100,000/mcL, hemoglobin ≥ 9 g/mL, Aspartate Aminotransferase (AST) (Serum Glutamic-Oxaloacetic Transaminase) (SGOT) to Alanine Aminotransferase (ALT), (Serum Glutamic-Pyruvic Transaminase) (SGPY) ratio (AST (SGOT)/ALT (SGPT)) \< 2.5 x institutional upper limit of normal (ULN), total bilirubin less than or equal to 1.5 x institutional ULN, serum creatinine \< 1.5 x institutional ULN.
- Stage I-III breast cancer scheduled to undergo adjuvant or neoadjuvant paclitaxel-based chemotherapy for breast cancer using doxorubicin 60 mg/m² and cyclophosphamide 600 mg/m² followed by paclitaxel 80 mg/m² weekly for 12 weeks protocol code BRAJACTW [23].
- Vitamin D insufficiency defined as serum level \< 30 ng/ml.
- Ability to give informed consent as per the legal requirement.
Who cannot join
- Prior neurotoxic chemotherapy including paclitaxel.
- Metastatic carcinoma.
- History of any other malignancy except malignancy that was treated with curative intent and for which there has been no known active disease for more than 3 years prior to randomization, curatively treated non-melanoma skin malignancy, cervical cancer in situ, in situ ductal carcinoma, or breast in situ lobular carcinoma.
- Grade II neuropathy or higher based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. neurosensory or neuromotor neuropathy, regardless of causality.
- Patients who are scheduled to receive any neurotoxic chemotherapeutic agents such as platinum compounds (carboplatin, cisplatin), vinorelbine, eribulin, and ixabepilone.
- Diabetes mellitus
Show all 23Show fewer
- Psychiatric disorders that limit ability to comply with study protocol i.e., history of regular exacerbation of major psychosis (schizophrenia, bipolar disorder) in last 2 years.
- Known Fibromyalgia
- Gastric bypass surgery.
- Patients with chronic granuloma forming disorders (sarcoidosis or tuberculosis TB).
- Known hyperparathyroidism.
- Known thyroid dysfunction.
- Known positive test for human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection.
- Pregnancy and lactation.
- Hypercalcemia (corrected blood calcium \> 10.5 mg/dl or \> 2.6 mmol/L)[24]
- Hyperphosphatemia, serum phosphate concentration \> 4.5 mg/dL [25]
- History of symptomatic genitourinary stones within the past year.
- Allergy to any cholecalciferol dosage form component.
- Alcohol consumption.
- Regular use of vitamin D \> 2000 IU daily over the past year.
- Inability to swallow pills.
- Medications that may interfere with vitamin D metabolism, including enzyme inducing anticonvulsants, lithium, phenytoin, verapamil, orlistat, tuberculosis medications as isoniazid, and/or rifampin and estrogen-containing medications.
- Patients receiving any of the following medications used to prevent CIPN: vitamin E, glutamine, nortriptyline, amitriptyline, tricyclic antidepressants, pregabalin, and duloxetine and other nutritional supplements as vitamin B during taxane administration.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Ain Shams University (El-Demerdash) Hospital
Cairo
Abdelrahman Mahmoud Dosoky, Dr, +201148534951, abdalrahman.mahmoud@pharma.cu.edu.eg
About this study
Official title: The Effect of Vitamin D Supplementation in Breast Cancer Patients Receiving Taxane-based Chemotherapy
It is a randomized clinical trial aimed at exploring the neuroprotective effect of vitamin D3 (Cholecalciferol) supplementation in conjunction with paclitaxel-based chemotherapy among breast cancer patients with vitamin D insufficiency or deficiency.
Read the detailed description
This study is a two-arm randomized controlled trial with 132 participants, evenly randomized into an intervention group and a control group. Both groups are scheduled to receive Adriamycin-Cyclophosphamide followed by paclitaxel (AC-T) chemotherapy protocol. The intervention group will undergo paclitaxel-based chemotherapy, along with vitamin D replacement therapy. Conversely, the control group will follow the AC-T protocol without the addition of vitamin D replacement therapy.
- Conditions
- Peripheral Neuropathic Pain
- Being tested
- Vitamin D (Cholecalciferol )
- Keywords
- Cholecalciferol, Breast cancer, Neuropathic pain, Taxane, Paclitaxel, Vitamin D3
- Medical subject headings
- Breast Neoplasms, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D (Cholecalciferol )Drug
In conjunction with the AC-T chemotherapy protocol, individuals in the intervention group who have a vitamin D deficiency will receive an oral loading dose of 50,000 IU weekly for eight weeks. Subsequently, they will be given 100,000 IU monthly until the completion of their chemotherapy treatment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | In conjunction with the AC-T chemotherapy protocol, individuals in the intervention group who have a vitamin D deficiency will receive vitamin D replacement therapy. Receives: Drug: Vitamin D (Cholecalciferol ) |
| The control group | No intervention | only the standard of care will be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cumulative incidence and grading of paclitaxel-induced peripheral neuropathy (PIPN)
The incidence and grading of paclitaxel-induced peripheral neuropathy (PIPN) will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
Measured: PIPN will be assessed throughout the 12-weeks paclitaxel administration phase.
Secondary outcomes (3)
The modified total neuropathy score mTNS.
The Modified Total Neuropathy Score (mTNS) is a tool including six items that evaluate peripheral neuropathy symptoms by their presence, location, and characteristics, including sensory and motor symptoms, response to pinprick, vibration sensitivity, muscle strength, and deep tendon reflexes. Each item is scored on a scale from 0 to 4, with the total possible score ranging from 0 to 24. The sum of these scores yields a total score, with higher scores indicating more severe neuropathy.
Measured: The change in mTNS will be compared at weeks 18 and 24 relative to baseline.
EORTC QLQ-CIPN20
The assessment of taxane-induced peripheral neuropathy will be carried out through interviews utilizing the Arabic version of the EORTC QLQ-CIPN20. This 20-item questionnaire, which includes sensory, motor, and autonomic subscales, will be employed for evaluations.
Measured: Taxane-induced peripheral neuropathy using (EORTC QLQ-CIPN20) at weeks 13, 15,18, 21 and 24.
Quality of life
Quality of life (QOL) assessments will be conducted through interviews utilizing the Arabic version of the Functional Assessment of Cancer Therapy Breast Symptom Index (FBSI).
Measured: Quality of life (QOL) assessed at the first week, then at weeks 13 and 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Oct 2024 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Neuropathic PainStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abdelrahman Mahmoud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abdelrahman Mahmoud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596122
- Sponsor's protocol ID
- Vitamin D in cancer patients
- Status last verified
- Sep 2024
- First submitted
- 11 Sep 2024
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D Supplementation in Breast Cancer Patients Receiving Taxane-based Chemotherapy
- ClinicalTrials.gov ID
- NCT06596122
- Acronym / sponsor ID
- Vitamin D in cancer patients
- Conditions
- Peripheral Neuropathic Pain
- Keywords
- Cholecalciferol, Breast cancer, Neuropathic pain, Taxane, Paclitaxel, Vitamin D3
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Abdelrahman MahmoudUniversity, hospital or other
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 19 Sep 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.
It is a randomized clinical trial aimed at exploring the neuroprotective effect of vitamin D3 (Cholecalciferol) supplementation in conjunction with paclitaxel-based chemotherapy among breast cancer patients with vitamin D insufficiency or deficiency.
Detailed description
This study is a two-arm randomized controlled trial with 132 participants, evenly randomized into an intervention group and a control group. Both groups are scheduled to receive Adriamycin-Cyclophosphamide followed by paclitaxel (AC-T) chemotherapy protocol. The intervention group will undergo paclitaxel-based chemotherapy, along with vitamin D replacement therapy. Conversely, the control group will follow the AC-T protocol without the addition of vitamin D replacement therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Drug: Vitamin D (Cholecalciferol )In conjunction with the AC-T chemotherapy protocol, individuals in the intervention group who have a vitamin D deficiency will receive vitamin D replacement therapy. |
| The control group | No intervention | –only the standard of care will be administered. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female aged 18 to 65 years old.
- Histologically confirmed breast cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2 [21] [22].
- All patients should fulfill the criteria of the initiation of taxane-based chemotherapy such as absolute neutrophil count (ANC) \> 1,500/mcL, platelets \> 100,000/mcL, hemoglobin ≥ 9 g/mL, Aspartate Aminotransferase (AST) (Serum Glutamic-Oxaloacetic Transaminase) (SGOT) to Alanine Aminotransferase (ALT), (Serum Glutamic-Pyruvic Transaminase) (SGPY) ratio (AST (SGOT)/ALT (SGPT)) \< 2.5 x institutional upper limit of normal (ULN), total bilirubin less than or equal to 1.5 x institutional ULN, serum creatinine \< 1.5 x institutional ULN.
- Stage I-III breast cancer scheduled to undergo adjuvant or neoadjuvant paclitaxel-based chemotherapy for breast cancer using doxorubicin 60 mg/m² and cyclophosphamide 600 mg/m² followed by paclitaxel 80 mg/m² weekly for 12 weeks protocol code BRAJACTW [23].
Key exclusion criteria (23 listed)
- Prior neurotoxic chemotherapy including paclitaxel.
- Metastatic carcinoma.
- History of any other malignancy except malignancy that was treated with curative intent and for which there has been no known active disease for more than 3 years prior to randomization, curatively treated non-melanoma skin malignancy, cervical cancer in situ, in situ ductal carcinoma, or breast in situ lobular carcinoma.
- Grade II neuropathy or higher based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. neurosensory or neuromotor neuropathy, regardless of causality.
- Patients who are scheduled to receive any neurotoxic chemotherapeutic agents such as platinum compounds (carboplatin, cisplatin), vinorelbine, eribulin, and ixabepilone.
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 |
|---|---|---|
| Vitamin D (Cholecalciferol )In conjunction with the AC-T chemotherapy protocol, individuals in the intervention group who have a vitamin D deficiency will receive an oral loading dose of 50,000 IU weekly for eight weeks. Subsequently, they will be given 100,000 IU monthly until the completion of their chemotherapy treatment. | Drug | Intervention group |
Primary outcome
The cumulative incidence and grading of paclitaxel-induced peripheral neuropathy (PIPN)
Time frame: PIPN will be assessed throughout the 12-weeks paclitaxel administration phase.
The incidence and grading of paclitaxel-induced peripheral neuropathy (PIPN) will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
3 secondary outcomes
The modified total neuropathy score mTNS.
Time frame: The change in mTNS will be compared at weeks 18 and 24 relative to baseline.
EORTC QLQ-CIPN20
Time frame: Taxane-induced peripheral neuropathy using (EORTC QLQ-CIPN20) at weeks 13, 15,18, 21 and 24.
Quality of life
Time frame: Quality of life (QOL) assessed at the first week, then at weeks 13 and 24.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D (Cholecalciferol ) in people with Peripheral Neuropathic Pain, run by Abdelrahman Mahmoud at 1 site in Egypt.
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 7 inclusion and 23 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: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdelrahman Mahmoud Dosoky, Dr (1148534951 ext. 0020, abdalrahman.mahmoud@pharma.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cumulative incidence and grading of paclitaxel-induced peripheral neuropathy (PIPN) (time frame: PIPN will be assessed throughout the 12-weeks paclitaxel administration phase.). 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 19 Sep 2024.