Evaluation of the Efficacy of Low-dose Acetylsalicylic Acid on Diarrhea Induced by Anti-cancer Targeted Therapies. (ASPIDIA)
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|ClinicalTrials.gov Identifier: NCT02323516|
Recruitment Status : Withdrawn
First Posted : December 23, 2014
Last Update Posted : December 8, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: Acetylsalicylic acid + loperamide Drug: diosmectite + loperamide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Efficacy of Low-dose Acetylsalicylic Acid on Diarrhea Induced by Anti-cancer Targeted Therapies.|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Acetylsalicylic acid + loperamide
Acetylsalicylic acid + loperamide
Drug: diosmectite + 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
Drug: Acetylsalicylic acid + loperamide
In case of inefficiency in one month, according to predefined criteria, acetylsalicylic acid will be stopped and replaced by diosmectite.
- 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
- 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.
- TKI dose reduction [ Time Frame: Three months ]Proportion of patients requiring dose reduction of targeted therapy
- Quality of life [ Time Frame: Three months ]Quality of life and its evolution by month using ladders FACIT-G and FACIT-D.
- 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
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): NCT02323516
|Centre François Baclesse|
|Caen, France, 14076|
|Centre Hospitalier public du Cotentin|
|Cherbourg, France, 50100|
|Centre Léon Bérard|