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Breast CancerPhase 3PREMED-F1NCT04237090

Feasibility of a Clinical Trial Comparing the Use of Cetirizine to Replace Diphenhydramine in the Prevention of Reactions Related to Paclitaxel

A Phase 3 study testing Diphenhydramine, Cetirizine and Lactose pill in people with Breast Cancer and Lung Cancer, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Explore the randomized, controlled, double-blind design targeted for the final clinical trial to assess the acceptability of interventions and clinical outcome measures and to provide data making it possible to estimate the parameters necessary for the preparation, modification or even abandonment of the final study. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Lung Cancer, Ovarian Cancer
What is being tested?
Diphenhydramine, Cetirizine and Lactose pill
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteCanada
Study dates
14 Feb 2020to 4 Sep 2020
Phase
Phase 3
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

  • Receiving intravenous chemotherapy treatments at the Maisonneuve-Rosemont hospital outpatient oncology clinic
  • Starting their first lifetime treatment with paclitaxel (alone or in combination with other anticancer agents).
  • Capable of giving free and informed consent and who agrees to participate by signing the consent form
  • Aged 18 and over
  • Able to complete questionnaires

Who cannot join

  • Does not understand French or English
  • Taking chronic H1 antagonist orally
  • Taking chronic systemic corticosteroids
  • Contraindication or possible medical danger, such as a documented allergy or previous intolerance, related to the administration of cetirizine, diphenhydramine, placebo or any ingredient in their formulation
  • Has received paclitaxel, docetaxel or paclitaxel nanoparticles linked to albumin in the past
  • Receiving paclitaxel nanoparticles linked to albumin
Show all 12Show fewer
  • Severe renal impairment (Cockcroft-Gault <10 milliliters/minute)
  • Pregnant or breastfeeding women
  • Receiving paclitaxel under desensitization protocol
  • Documented or reported dysphagia or other pathophysiological condition preventing a tablet from being swallowed whole
  • Interactions preventing the full dose of oral cetirizine from being absorbed
  • Participating in another clinical trial simultaneously

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • CIUSSS de l'Est-de-l'île-de-Montréal

    Montreal, Quebec, H1T 2M4

Other trials in Canada

About this study

Official title: Feasibility of a Randomized Controlled Clinical Trial Comparing the Use of Cetirizine to Replace Diphenhydramine in the Prevention of Reactions Related to Paclitaxel

Explore the randomized, controlled, double-blind design targeted for the final clinical trial to assess the acceptability of interventions and clinical outcome measures and to provide data making it possible to estimate the parameters necessary for the preparation, modification or even abandonment of the final study.

Read the detailed description

Paclitaxel is known to cause 30 to 40% of infusion-related reactions when no premedication is administered. It is agreed that all patients should receive premedication with dexamethasone, an H1 antagonist, such as diphenhydramine, and an H2 antagonist before the administration of paclitaxel. There are several cases where undesirable effects (eg. drowsiness, dry mouth, motor impatience) have been reported following the administration of this conventional premedication. Diphenhydramine is often accused because of its pharmacological properties.

A definitive, randomized, double-blind, non-inferiority study can assess whether cetirizine, a non-sedating H1 antagonist, can be used as an effective and safe alternative to diphenhydramine in the prevention of paclitaxel infusion-related reactions.

In the current proposed feasibility study, patients will be followed for the first two doses of paclitaxel. The goal is to explore the randomized, controlled, double-blind design targeted for the final clinical trial to assess the acceptability of interventions and clinical outcome measures and to provide data making it possible to estimate the parameters necessary for the preparation, modification or even abandonment of the final study.

Being tested
Diphenhydramine, Cetirizine, Lactose pill, Sodium chloride 0.9%
Medical subject headings
Breast Neoplasms, Lung Neoplasms, Ovarian Neoplasms, Esophageal Neoplasms, Head and Neck Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DiphenhydramineDrug

    Also called Benadryl

    Drug identification number : 02369567

  • CetirizineDrug

    Also called Reactine

    Drug identification number : 02231603

  • Lactose pillDrug

    Natural product number : 00501190

  • Sodium chloride 0.9%Drug

    Drug identification number : 00037796

Study groups in NCT04237090
Study groupRoleWhat they receive
Diphenhydramine + placeboActive comparatorDiphenhydramine 50 mg intravenous given in a 50 milliliters bag of sodium chloride 0.9 percent, with famotidine, 30 minutes before the paclitaxel infusion. 15 minutes infusion. Lactose tablet 100 mg per os given 30 minutes before the paclitaxel infusion.with a 180 milliliters glass of water.
Receives: Drug: Diphenhydramine; Drug: Lactose pill
Cetirizine + placeboExperimentalCetirizine tablet 10 mg per os given 30 minutes before the paclitaxel infusion.with a 180 milliliters glass of water. 1 milliliter of sodium chloride 0,9 percent intravenous given in a 50 milliliters bag of sodium chloride 0.9 percent, with famotidine, 30 minutes before the paclitaxel infusion. 15 minutes infusion.
Receives: Drug: Cetirizine; Drug: Sodium chloride 0.9%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline of drowsiness on Stanford Sleepiness Scale 1 hour after the administration of diphenhydramine

    For treatment 1 and treatment 2

    Measured: 15 minutes before the administration of diphenhydramine. 1 hour after the administration of diphenhydramine.

  2. Change from baseline of drowsiness on Stanford Sleepiness Scale upon arrival at home

    For treatment 1 and treatment 2

    Measured: 15 minutes before the administration of diphenhydramine. Upon arrival at home.

  3. Change from baseline of drowsiness on Stanford Sleepiness Scale the morning after the administration of diphenhydramine

    For treatment 1 and treatment 2

    Measured: 15 minutes before the administration of diphenhydramine. Morning of day 2.

  4. Recruitment rate accomplished to recruit 24 participants for which a first dose of paclitaxel was administered between February and September 2020.

    Number of participants per month recruited for which a first dose of paclitaxel was administered

    Measured: Through study completion, 8 months

  5. Percentage of participants recruited, randomized and having received the first treatment of paclitaxel planned in the study between February and September 2020 following an assessment of their eligibility.

    Number of participants recruited, randomized and having received the first treatment of paclitaxel planned in the study divided by the number of participants eligible to participate in the study

    Measured: Through study completion, 8 months

Secondary outcomes (2)

  1. Proportion of participants per group who required stopping the infusion and/or using rescue medication.

    Stopping the infusion and using rescue medication defined by the medical choice of the attending physician. For treatment 1 and treatment 2.

    Measured: Day 1

  2. Infusion-related reactions grade according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 classification

    Grades will be determined using nurses notes. For treatment 1 and treatment 2

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2020
  2. Study start14 Feb 2020
  3. Primary completion28 Aug 2020
  4. Study completion4 Sep 2020

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04237090
Sponsor's protocol ID
2020-2110
Acronym
PREMED-F1
Status last verified
Oct 2020
First submitted
17 Jan 2020
Last updated
12 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Weiss RB, Donehower RC, Wiernik PH, Ohnuma T, Gralla RJ, Trump DL, Baker JR Jr, Van Echo DA, Von Hoff DD, Leyland-Jones B. Hypersensitivity reactions from taxol. J Clin Oncol. 1990 Jul;8(7):1263-8. doi: 10.1200/JCO.1990.8.7.1263.

    PubMed 1972736

  • Picard M, Castells MC. Re-visiting Hypersensitivity Reactions to Taxanes: A Comprehensive Review. Clin Rev Allergy Immunol. 2015 Oct;49(2):177-91. doi: 10.1007/s12016-014-8416-0.

    PubMed 24740483

  • Picard M. Management of Hypersensitivity Reactions to Taxanes. Immunol Allergy Clin North Am. 2017 Nov;37(4):679-693. doi: 10.1016/j.iac.2017.07.004. Epub 2017 Aug 18.

    PubMed 28965634

  • Durham CG, Thotakura D, Sager L, Foster J, Herrington JD. Cetirizine versus diphenhydramine in the prevention of chemotherapy-related hypersensitivity reactions. J Oncol Pharm Pract. 2019 Sep;25(6):1396-1401. doi: 10.1177/1078155218811505. Epub 2018 Nov 12.

    PubMed 30419768

  • Siderov J, Wendel N, Davis ID. Non-Sedating Antihistamines for Premedication in Ambulatory Oncology Patients. Journal of Pharmacy Practice and Research 2002; 32(2): 108-9.

  • del Cuvillo A, Mullol J, Bartra J, Davila I, Jauregui I, Montoro J, Sastre J, Valero AL. Comparative pharmacology of the H1 antihistamines. J Investig Allergol Clin Immunol. 2006;16 Suppl 1:3-12. No abstract available.

    PubMed 17357372

  • Banerji A, Long AA, Camargo CA Jr. Diphenhydramine versus nonsedating antihistamines for acute allergic reactions: a literature review. Allergy Asthma Proc. 2007 Jul-Aug;28(4):418-26. doi: 10.2500/aap.2007.28.3015.

    PubMed 17883909

  • Berger MJ, Vargo C, Vincent M, Shaver K, Phillips G, Layman R, Macrae E, Mrozek E, Ramaswamy B, Wesolowski R, Shapiro CL, Lustberg MB. Stopping paclitaxel premedication after two doses in patients not experiencing a previous infusion hypersensitivity reaction. Support Care Cancer. 2015 Jul;23(7):2019-24. doi: 10.1007/s00520-014-2556-x. Epub 2014 Dec 18.

    PubMed 25519756

  • Beaucage-Charron J, Gaudet L, Lamothe S, Pelletier C, Pepin AS, Roy V, Charpentier F, Lordkipanidze M, Projean D, Bouchard P, Picard M. A randomized double-blind feasibility study comparing cetirizine and diphenhydramine in the prevention of paclitaxel-associated infusion-related reactions: the PREMED-F1 study. Support Care Cancer. 2022 Apr;30(4):3389-3399. doi: 10.1007/s00520-021-06734-4. Epub 2022 Jan 8.

    PubMed 34997314

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Diphenhydramine, Cetirizine and Lactose pill in people with Breast Cancer and Lung Cancer, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.

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 5 inclusion and 12 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 12 Oct 2020. 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 Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Change from baseline of drowsiness on Stanford Sleepiness Scale 1 hour after the administration of diphenhydramine (time frame: 15 minutes before the administration of diphenhydramine. 1 hour after the administration of diphenhydramine.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04237090, which also lists 9 linked publications.

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 12 Oct 2020.

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