Breast CancerPhase 1/2NCT06265077
Novel Preventive Approach Against Filgrastim-Induced Bone Pain in Cancer Patients
A Phase 1/2 study testing famotidine and loratadine in people with Breast Cancer and Filgrastim Adverse Reaction, run by Noha Mansour at 1 site in Egypt.
Trial summary
No randomized controlled trial evaluated the safety and efficacy of double blockade on G-CSF induced bone pain. Therefore, this study aims to evaluate the efficacy and safety of double blockade on the incidence and severity of G-CSF induced bone pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Filgrastim Adverse Reaction
- What is being tested?
- famotidine and loratadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 17 Oct 2024
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients were 18 years or older.
- Confirmed diagnosis of breast cancer.
- Patients completed adriamycin and cyclophosphamide (AC) regimen and are planned to receive four cycles or more of paclitaxel chemotherapy with G-CSF support starting in cycle 1 and continuing throughout each of the four paclitaxel cycles.
- Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.
Who cannot join
- Patients with signs and symptoms of grade 2 or 3 bone pain at baseline.
- Patients receiving famotidine in the previous 72 hours.
- Patient receiving any antihistaminic in the previous 72 hours.
- Hypersensitivity to famotidine or loratadine.
- Patient receiving opioid or adjuvant analgesic.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Loratadine and Famotidine Combination on Preventing Filgrastim-Induced Bone Pain in Breast Cancer Patients
No randomized controlled trial evaluated the safety and efficacy of double blockade on G-CSF induced bone pain. Therefore, this study aims to evaluate the efficacy and safety of double blockade on the incidence and severity of G-CSF induced bone pain.
- Conditions
- Breast Cancer, Filgrastim Adverse Reaction
- Being tested
- Placebo, famotidine and loratadine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo
famotidine and loratadineDrug
famotidine 20 mg once daily and loratadine 10 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | (intervention group) patients who will receive filgrastim plus oral famotidine 20 mg once daily and loratadine 10 mg once daily for the full filgrastim treatment period. Receives: Drug: famotidine and loratadine |
| Control | Placebo comparator | (control group) patients who will receive placebo plus filgrastim. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of grade 2 or 3 bone pain in cycle 1 according to Common Terminology Criteria for Adverse Events
Difference between the two arms regarding the incidence of grade 2 or 3 bone pain in cycle 1 according to Common Terminology Criteria for Adverse Events
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Feb 2024
- Primary completion17 Oct 2024
- Study completion17 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noha Mansour
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Noha Mansour, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265077
- Sponsor's protocol ID
- 2023-199
- Status last verified
- Dec 2024
- First submitted
- 10 Feb 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Loratadine and Famotidine Combination on Preventing Filgrastim-Induced Bone Pain in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06265077
- Acronym / sponsor ID
- 2023-199
- Conditions
- Breast Cancer, Filgrastim Adverse Reaction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Noha MansourUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 17 Oct 2024 (actual)
- Study completion
- 17 Oct 2024 (actual)
- First posted
- 20 Feb 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.
No randomized controlled trial evaluated the safety and efficacy of double blockade on G-CSF induced bone pain. Therefore, this study aims to evaluate the efficacy and safety of double blockade on the incidence and severity of G-CSF induced bone pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Drug: famotidine and loratadine(intervention group) patients who will receive filgrastim plus oral famotidine 20 mg once daily and loratadine 10 mg once daily for the full filgrastim treatment period. |
| Control | Placebo comparator | Drug: Placebo(control group) patients who will receive placebo plus filgrastim. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Eligible patients were 18 years or older.
- Confirmed diagnosis of breast cancer.
- Patients completed adriamycin and cyclophosphamide (AC) regimen and are planned to receive four cycles or more of paclitaxel chemotherapy with G-CSF support starting in cycle 1 and continuing throughout each of the four paclitaxel cycles.
- Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.
Key exclusion criteria (5 listed)
- Patients with signs and symptoms of grade 2 or 3 bone pain at baseline.
- Patients receiving famotidine in the previous 72 hours.
- Patient receiving any antihistaminic in the previous 72 hours.
- Hypersensitivity to famotidine or loratadine.
- Patient receiving opioid or adjuvant analgesic.
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 |
|---|---|---|
| PlaceboPlacebo | Drug | Control |
| famotidine and loratadinefamotidine 20 mg once daily and loratadine 10 mg once daily | Drug | Intervention |
Primary outcome
The incidence of grade 2 or 3 bone pain in cycle 1 according to Common Terminology Criteria for Adverse Events
Time frame: two weeks
Difference between the two arms regarding the incidence of grade 2 or 3 bone pain in cycle 1 according to Common Terminology Criteria for Adverse Events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing famotidine and loratadine in people with Breast Cancer and Filgrastim Adverse Reaction, run by Noha Mansour 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 13 Dec 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of grade 2 or 3 bone pain in cycle 1 according to Common Terminology Criteria for Adverse Events (time frame: two weeks). 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 13 Dec 2024.