Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hématologie Adulte Prevalence of Adrenal Insufficiency Post-chemotherapy Adrenocorticotropia in Adult Hematology (HemaSur)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03688789
Recruitment Status : Not yet recruiting
First Posted : September 28, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:
A recent meta-analysis involving 3753 patients treated with corticosteroids notes that the population with the highest prevalence of biological IS (68%) is onco-hematology. However, it is also the least studied population with no recent and significant prevalence study. A recent multicenter study including patients followed up oncology who received dexamethasone for antiemetic purposes at cumulative doses well below the doses used in Hematology, objective a prevalence of biological IS estimated at 16% at 3 months from the start of chemotherapy. The introduction of a substitution had led to an objective improvement in the quality of life estimated by EORTC QLQ-C30.

Condition or disease Intervention/treatment Phase
Haematological Malignancy Other: Hydrocortisone supplementation Not Applicable

Detailed Description:

A recent meta-analysis involving 3753 patients treated with corticosteroids notes that the population with the highest prevalence of biological IS (68%) is onco-hematology. However, it is also the least studied population with no recent and significant prevalence study. A recent multicenter study including patients followed up oncology who received dexamethasone for antiemetic purposes at cumulative doses well below the doses used in Hematology, objective a prevalence of biological IS estimated at 16% at 3 months from the start of chemotherapy. The introduction of a substitution had led to an objective improvement in the quality of life estimated by EORTC QLQ-C30.

Expected results are prevalence rate of biological adrenal insufficiency between 15 and 20% with improvement of the quality of life in the 2 months post-chemotherapy by Hydrocortisone supplementation

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prevalence of Adrenal Insufficiency Post-chemotherapy Adrenocorticotropia in Adult Hematology
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 1, 2022


Arm Intervention/treatment
Experimental: Hydrocortisone supplementation Other: Hydrocortisone supplementation
  • Cortisol at T0 and T30 mins less than 550 nmol / L after ACTH 250 μG achieved during the last chemotherapy session
  • Hydrocortisone supplementation in patients with biological adrenal insufficiency
  • scale of quality of life estimated by EORTC QLQ-C30




Primary Outcome Measures :
  1. Cortisol at T0 and T30 mins less than 550 nmol / L after ACTH 250 μG achieved during the last chemotherapy session [ Time Frame: 30 min ]
    Cortisol at T0 and T30mins less than 550 nmol / L after ACTH 250 μG achieved during the last chemotherapy session


Secondary Outcome Measures :
  1. cumulative doses of corticosteroids in prednisone equivalent as well as duration of exposure [ Time Frame: 6 months ]
    cumulative doses of corticosteroids in prednisone equivalent as well as duration of exposure

  2. potential drug interactions (including CYP450 inducer) [ Time Frame: 6 months ]
    potential drug interactions (including CYP450 inducer)

  3. Evaluation of the effect on quality of life of Hydrocortisone supplementation in patients with biological IS in the wake of EORTC QLQ-C30 type self-administered chemotherapy at D0 and D30 [ Time Frame: 30 days ]
    Evaluation of the effect on quality of life of Hydrocortisone supplementation in patients with biological IS in the wake of EORTC QLQ-C30 type self-administered chemotherapy at D0 and D30



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Age> 18 years
  • Patient naive to any chemotherapy treatment, re-ceiving a 1st chemotherapy line of RCHOP, RCOP, VTD, VD or MPT type from the Adult Hematology Department
  • PS according to WHO = 0,1 and 2

Exclusion Criteria:

  • Adrenal pathology, hypothalamus or pre-existing pituitary gland (including metastatic lesions)
  • Long-term treatment with corticosteroids or in the previous 6 months
  • Refusal or absence of informed consent

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): NCT03688789


Contacts
Layout table for location contacts
Contact: Anne Hespel, PhD 199282555 ext 0033 drc@chu-rennes.fr
Contact: Brieuc Cherel, MD 299284321 ext 0033 brieuc.cherel@chu-rennes.fr

Sponsors and Collaborators
Rennes University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Brieuc Cherel, MD Rennes University Hospital
Layout table for additonal information
Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03688789    
Other Study ID Numbers: 35RC17_8996_HemaSur
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hematologic Neoplasms
Adrenal Insufficiency
Neoplasms
Adrenal Gland Diseases
Endocrine System Diseases
Neoplasms by Site
Hematologic Diseases
Hydrocortisone
Anti-Inflammatory Agents