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Doxycycline vs Isotretinoin for Acneiform Eruptions of TKI

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ClinicalTrials.gov Identifier: NCT04864717
Recruitment Status : Not yet recruiting
First Posted : April 29, 2021
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
Kevin Pehr, Lady Davis Institute

Brief Summary:

Tyrosine Kinase inhibitors (TKIs) have become standard of care in patients with EGFR mutations in non-small cell lung cancer and other EGFR-mutated cancers. However, TKIs are well-known to cause cutaneous adverse events, including acneiform eruptions. Moderate to severe acneiform eruptions are often associated with severe pruritus and pain. Current treatment recommendations rely on expert consensus. Moderate and severe reactions requiring systemic therapy, usually tetracycline antibiotics or isotretinoin. No randomized trial has compared the relative effectiveness of tetracyclines versus isotretinoin.

The objective of this unblinded, randomized trial is to compare tetracyclines to isotretinoin for treatment of moderate to severe acneiform eruptions in cancer patients on tyrosine kinase inhibitors. The primary aim of this clinical trial is to elucidate which systemic treatment is more effective in clearing acneiform eruptions caused by TKIs. The results of this study will add to the literature in this field and will aid in developing evidence based clinical guidelines.


Condition or disease Intervention/treatment Phase
Acneiform Eruptions Cancer, Treatment-Related Drug: Doxycycline 100mg po once daily x 6 months Drug: Isotretinoin 40 mg po once daily x 6 months Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two arm study: one arm isotretinoin, one arm doxycycline.
Masking: None (Open Label)
Masking Description: Unblinded
Primary Purpose: Treatment
Official Title: A Randomized Control Trial to Compare Doxycycline to Isotretinoin for the Treatment of Acneiform Eruptions in Cancer Patients on Tyrosine Kinase Inhibitors
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

Arm Intervention/treatment
Active Comparator: Doxycycline
Doxycycline 100mg po once daily x 6 months
Drug: Doxycycline 100mg po once daily x 6 months
active intervention

Active Comparator: Isotretinoin
Isotretinoin 40mg po once daily x 6 months
Drug: Isotretinoin 40 mg po once daily x 6 months
active intervention




Primary Outcome Measures :
  1. Quantitative improvement in acneiform eruptions in cancer patients on tyrosine kinase inhibitors as defined by a change in Leeds Revised Acne Grading Scale. [ Time Frame: 6 months ]
    Change in Leeds revised acne grading scale score between the baseline visit and six months or end of treatment with tyrosine kinase inhibitor, whichever is sooner. Leeds revised acne score ranges from 1 to 28, with higher being worse. Mild defined as 3-8, moderate defined as 11-20 and severe defined as 21-28.


Secondary Outcome Measures :
  1. Quantitative change on patient's quality of life with treatment of the acneiform eruption as measured by the dermatology life quality index scale. [ Time Frame: 6 months ]
    Patients' perception of the severity of the eruption, and its impact on their lives, before, during and after therapy using the dermatology life quality index scale, range 0-40, with higher being worse

  2. Response of malignancy to cancer therapy using RECIST v1.1 guidelines [ Time Frame: 6 months ]
    To assess response of the primary malignancy to tyrosine kinase inhibitor therapy while on the study medication using the oncology standard of care RECIST v1.1 guidelines: Complete response (CR), Partial response (PR), Stable disease (SD), Progressive disease (PD)

  3. Adverse events from the study medications as defined using the CTCAE version 5.0 guidelines [ Time Frame: 6 months ]
    To assess adverse events from combined therapy study medication and TKI using the National Institute of Health CTCAE version 5.0 guidelines. Link: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcae_v5_quick_reference_8.5x11.pdf



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participant must be ≥18 years of age, able to understand the study procedures, and agrees to participate in the study by providing written informed consent
  2. Participant has histologically- or pathologically-confirmed cancer with a known sensitizing EGFR mutation.
  3. Participants must have started EGFR-TKI treatment, and subsequently had an acneiform eruption rated moderate or severe per the Leeds scale.
  4. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
  5. Participant has a life expectancy of at least 3 months.
  6. Premenopausal participants must use highly effective method of contraception. Female participants are neither pregnant nor breastfeeding

Exclusion Criteria:

  1. Absolute contraindications: pregnancy, breastfeeding, drug allergy
  2. Relative contraindications:

    1. moderate to severe hypercholesterolemia (total cholesterol >7.8 mmol/L)
    2. hypertriglyceridemia (TG >2.55 mmol/L)
    3. significant hepatic dysfunction (AST > 55IU/L, ALT > 94 IU/L)
    4. suicidal ideation, pseudotumor cerebri
    5. refractory nausea or vomiting
    6. GI pathology that would prevent absorption of oral therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04864717


Contacts
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Contact: Kevin Pehr, MD (514) 935-1051 kevin.pehr@mcgill.ca
Contact: Rachel Bierbrier rmbresearch2020@gmail.com

Sponsors and Collaborators
Lady Davis Institute
Additional Information:
Publications:
Sc O'brien, Jb Lewis & Wj Cunliffe (1998) The Leeds revised acne grading system, Journal of Dermatological Treatment, 9:4, 215-220, DOI: 10.3109/09546639809160698
Bolognia, Jean., Jorizzo, Joseph L.Schaffer, Julie V., eds. Dermatology. [Philadelphia] :: Elsevier Saunders, 2012. Print.
Wolverton, S., 2020. Comprehensive Dermatologic Drug Therapy. 4th ed. Elsevier, pp.Chapters 9, 22. In.

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Responsible Party: Kevin Pehr, Senior Investigator/Chercheur Clinicien, Lady Davis Institute
ClinicalTrials.gov Identifier: NCT04864717    
Other Study ID Numbers: 2021-2635
First Posted: April 29, 2021    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Kevin Pehr, Lady Davis Institute:
Isotretinoin
Doxycyline
Tyrosine Kinase Inhibitors
EGFR Gene Mutation
Additional relevant MeSH terms:
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Neoplasms, Second Primary
Exanthema
Acneiform Eruptions
Skin Diseases
Neoplasms
Doxycycline
Isotretinoin
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Dermatologic Agents