A Phase 4 interventional study of Doxycycline 100mg po once daily x 6 months and Isotretinoin 40 mg po once daily x 6 months in Acneiform Eruptions and Cancer, Treatment-Related, sponsored by Lady Davis Institute. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-08.
Sponsored by Lady Davis Institute · Phase 4, Interventional, and Treatment
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.
Background and Study Aims:
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. The study will be held at Jewish General Hospital, Division of Dermatology, G026, 3755 Cote Ste Catherine, Montreal (Quebec) H3T 1E2.
Who can participate? This study is open to adult patients (>18 years old) at the Jewish General Hospital who have a histologically- or pathologically-confirmed cancer with a known sensitizing EGFR mutation. Participants must have started EGFR-TKI treatment, and subsequently had an acneiform eruption rated moderate or severe per the Leeds scale. Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2, a life expectancy of at least 3 months. Premenopausal participants must use highly effective method of contraception. Female participants are neither pregnant nor breastfeeding
What does the study involve?
Participants who meet the inclusion criteria will be referred to dermatology by their treating oncologist. Participants will meet with dermatology to confirm their diagnosis, review the study protocol and ensure no exclusion criteria are met. If the participant agrees to participate in the trial, signed consent will be obtained and the participant will be randomly assigned to either the doxycycline or isotretinoin group. Participants will receive a prescription for their prescribed medication and will get the medication from their preferred pharmacy. Participants will continue regular follow up with their oncologists as per standard of care. Dermatologic study visits coincide with the follow up visit by the treating Oncologist. During these dermatology visits the following will take place:
No extra blood tests will be ordered for the study, but the blood tests already ordered by oncology will be reviewed to ensure that there are no adverse effects from the study medication. The total study duration is six months. At the end of six months, participants can choose to continue to be followed by dermatology and may continue treatment. If a participant withdraws from the study prior to six months, they will still have access to a dermatologist for treatment of the acneiform eruption.
What are the possible benefits and risks of participating? The investigators cannot guarantee that participants will receive any benefits from this study. However, this study will make an important contribution to the field of cancer care and clinical research by providing essential information on the effective treatment of common skin side effects of TKI treatment of cancer patients in the clinical setting.
Participants may have side effects from the drugs used in this study. Side effects can vary from mild to serious and may vary from person to person. Everyone taking part in the study will be watched carefully for any side effects.
All patients will be counselled on the usual adverse effects of the study medicines. In addition, specific counselling, and special emphasis, will be made for the following:
Doxycycline may cause diarrhea, nausea, vomiting, exaggerated sunburn reactions, skin rash, low blood counts, liver problems, elevated intracranial pressure (which may cause changes in vision, nausea/vomiting or headaches). Some patients may develop an allergic reaction to the medication.
Isotretinoin may lead to an increase in cholesterol and triglyceride levels, liver problems, muscle pains elevated intracranial pressure (which may cause changes in vision, nausea/vomiting or headaches), abnormal development of a fetus for women who become pregnant on the medication, eye changes (dryness, decreased night vision), joint pains, pancreatitis (in patients with high blood triglyceride levels). Rarely, patients can develop a severe allergic reaction to the medication. Isotretinoin may also cause depression.
Participants will be closely monitored, including with regular bloodwork to ensure that they do not have any serious side effects to the study medications. At each visit, the study dermatologist will ask about any new symptoms that may suggest an adverse reaction to the medication. If a severe side effect develops, the study medication will be stopped and participants will be closely monitored.
Where is the study run from? The study will take place at the Jewish General Hospital in Montreal QC, Canada.
When is the study starting and how long is it expected to run for? The aim is to start the study as soon as ethics approval is obtained. The estimated start and stop dates of the trial are 01/06/2021 to 01/06/2022. The total study duration for each participant is 6 months.
Who is funding the study? There is no funding for the study.
Who is the main contact? The main contact of the study is the principal investigator. Dr. Kevin Pehr. Jewish General Hospital Senior Investigator/Chercheur Clinicien, Lady Davis Institute Associate Professor Dermatology McGill University Chief Multidisciplinary Cutaneous Lymphoma Clinic 2727B rue St Patrick Montréal (Québec) H3K 0A8 Canada (o) 514-935-1051; (c) 514-880-5122; (fax) 514-932-3793 email: kevin.pehr@mcgill.ca
96 studies on the registry are indexed under Neoplasms, Second Primary; 35 are open to participants now.
This study's planned enrollment of 98 is above the median of 82 across 48 interventional studies indexed under Neoplasms, Second Primary.
Browse Neoplasms, Second Primary studies →Lady Davis Institute is the lead sponsor of 46 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Relative contraindications:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Doxycycline 100mg po once daily x 6 months
Drug: Doxycycline 100mg po once daily x 6 months
Isotretinoin 40mg po once daily x 6 months
Drug: Isotretinoin 40 mg po once daily x 6 months
active intervention
active intervention
Quantitative improvement in acneiform eruptions in cancer patients on tyrosine kinase inhibitors as defined by a change in Leeds Revised Acne Grading Scale.
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.
Time frame: 6 months
Quantitative change on patient's quality of life with treatment of the acneiform eruption as measured by the dermatology life quality index scale.
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
Time frame: 6 months
Response of malignancy to cancer therapy using RECIST v1.1 guidelines
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)
Time frame: 6 months
Adverse events from the study medications as defined using the CTCAE version 5.0 guidelines
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
Time frame: 6 months
Plan to share: No
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Doxycycline · Isotretinoin
Lady Davis Institute