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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03688789
Other study ID # 35RC17_8996_HemaSur
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date December 1, 2022

Study information

Verified date March 2023
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 1, 2022
Est. primary completion date July 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Rennes University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Cortisol at T0 and T30 mins less than 550 nmol / L after ACTH 250 µG achieved during the last chemotherapy session Cortisol at T0 and T30mins less than 550 nmol / L after ACTH 250 µG achieved during the last chemotherapy session 30 min
Secondary cumulative doses of corticosteroids in prednisone equivalent as well as duration of exposure cumulative doses of corticosteroids in prednisone equivalent as well as duration of exposure 6 months
Secondary potential drug interactions (including CYP450 inducer) potential drug interactions (including CYP450 inducer) 6 months
Secondary 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 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 30 days
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