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Trial record 28 of 87 for:    ASPIRIN AND thromboxane

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Recruitment Status : Withdrawn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
Sponsor:
Collaborators:
Ligue contre le cancer, France
Canceropôle Nord Ouest
Information provided by (Responsible Party):
Centre Francois Baclesse

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. TKI dose reduction [ Time Frame: Three months ]
    Proportion of patients requiring dose reduction of targeted therapy

  3. Quality of life [ Time Frame: Three months ]
    Quality of life and its evolution by month using ladders FACIT-G and FACIT-D.

  4. 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



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

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.

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): NCT02323516


Locations
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France
CHU
Amiens, France
Centre François Baclesse
Caen, France, 14076
Centre Hospitalier public du Cotentin
Cherbourg, France, 50100
Centre hospitalier
Compiegne, France
Centre Léon Bérard
Lyon, France
Sponsors and Collaborators
Centre Francois Baclesse
Ligue contre le cancer, France
Canceropôle Nord Ouest

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Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT02323516     History of Changes
Other Study ID Numbers: ASPIDIA
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Aspirin
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Loperamide
Antidiarrheals
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Gastrointestinal Agents