- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02323516
Evaluation of the Efficacy of Low-dose Acetylsalicylic Acid on Diarrhea Induced by Anti-cancer Targeted Therapies. (ASPIDIA)
The mechanisms of action of the side effects associated with targeted therapies are still poorly understood. He was found in patients treated with gefitinib, increased levels of thromboxane B2 and P-selectin Thromboxane B2 is the result of the hydrolysis of thromboxane A2, which is itself obtained from Prostaglandin H2 under the action of the thromboxane synthetase. The thromboxane A2 is produced by platelets and the active pro-thrombotic properties as follows: stimulation of platelets and activation of other increased platelet aggregation.
The selectins are cell adhesion proteins with a role in the adhesion phenomena. P-selectin is expressed by platelets and endothelial cells.
The demonstration of increased plasma levels of thromboxane B2 and P-selectin leaves suggest a role of platelet activation in the occurrence of side effects associated with targeted therapies.
Kanazawa's study was conducted in 39 Japanese patients, trying to assess the value of low-dose acetylsalicylic acid or 100mg per day, that is to say, anti-aggrégantes doses, the occurrence rash and diarrhea induced by gefitinib.
In this study, the group of patients treated with acetylsalicylic acid presented a lower rate of side effects significantly, 58.3% versus 77.8%. The frequency of diarrhea was 18.5% (or 5 patients) in the standard group versus 0% in the group with acetylsalicylic acid. Similarly, it was found a reduction in the occurrence of skin rash, 33.3% or 4 patients in the acetylsalicylic acid group versus 74.1% s, 20 patients in the standard group. Finally, in this study, it was not revealed significant differences in terms of response to treatment with gefitinib (37% in the standard group versus 33% in the group treated with aspirin patient) It does not exist in our knowledge of prospective data evaluating the effect of acetylsalicylic acid on the reduction of side effects associated with targeted in a population of patients of Caucasian-type treatment.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Amiens, France
- CHU
-
Caen, France, 14076
- Centre Francois Baclesse
-
Cherbourg, France, 50100
- Centre Hospitalier Public du Cotentin
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Compiegne, France
- Centre Hospitalier
-
Lyon, France
- Centre Léon Bérard
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged at least 18 years old patient;
- WHO 0 to 2;
- Any solid tumor or hematologic malignancy requiring a tyrosine kinase inhibitor prescription in the absence of digestive disorders related to tumor disease;
- Treatment with one of the following targeted therapies: Gefitinib, erlotinib, sunitinib, sorafenib, Axitinib, Pazopanib, Lapatinib, Imatinib, afatinib,vemurafenib and Dabrafenib;
- Targeted therapy treatment whatever the processing line monotherapy, administered over a period of at least 15 days with continued dosing, with usual care recommendations;
- Diarrhea grade 1-3 according to NCI criteria CTCAE.4, in the absence of complications signs with at least 2 doses of loperamide per day.
Exclusion Criteria:
- Processing acetylsalicylic acid;
- Allergy or against-indications to acetylsalicylic acid (including concomitant antiplatelet or anticoagulant considered as increasing the risk of bleeding by the investigator) acid;
- Treatment with anti vitamin K or new oral anticoagulants;
- Absolute in pursuit of targeted therapy contraindication;
- Chronic diarrhea prior to clinical introduction of targeted therapy;
Diarrhoea unrelated to targeted therapy such as:
- extended resection of esophagus, inflammatory bowel disease, etc ...
- carcinoid syndrome;
- occlusive syndrome;
- Grade 3 diarrhea with signs of complications or grade 4
- Patients with a history of grade 3 diarrhea with signs of complications or grade 4 during previous treatment with TKI;
- Participation in other medical test;
- Pregnant women / nursing;
- Association with methotrexate at doses > 15 mg / d;
- Patient Trust or deprived of liberty.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acetylsalicylic acid + loperamide
|
In case of inefficiency in one month, according to predefined criteria, diosmectite will be stopped and replaced by acetylsalicylic acid.
|
Active Comparator: diosmectite + loperamide
Acetylsalicylic acid + loperamide
|
In case of inefficiency in one month, according to predefined criteria, acetylsalicylic acid will be stopped and replaced by diosmectite.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy measured by the decrease in the intensity of diarrhea and / or anti-diarrheal consumption
Time Frame: 1 month
|
Effectiveness of acetylsalicylic acid versus diosmectite
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Toxicity
Time Frame: Three months
|
Diarrhea decrease 3 months after the introduction of acetylsalicylic acid or diosmectite; Proportion of patients with a decrease in the grade of diarrhea during the months following the introduction of acetylsalicylic acid or diosmectite.
Rate and intensity of side effects associated with other targeted therapy.
|
Three months
|
TKI dose reduction
Time Frame: Three months
|
Proportion of patients requiring dose reduction of targeted therapy
|
Three months
|
Quality of life
Time Frame: Three months
|
Quality of life and its evolution by month using ladders FACIT-G and FACIT-D.
|
Three months
|
Safety measured by the proportion of adverse event
Time Frame: Months 1 to 3
|
Safety of acetylsalicylic acid in patients with diarrhea in targeted therapy
|
Months 1 to 3
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Signs and Symptoms, Digestive
- Diarrhea
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Gastrointestinal Agents
- Aspirin
- Loperamide
- Antidiarrheals
Other Study ID Numbers
- ASPIDIA
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