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

Haematological Malignancy Clinical Trial

— HemaSur  

Official title:

Prevalence of Adrenal Insufficiency Post-chemotherapy Adrenocorticotropia in Adult Hematology

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03688789
• Other study ID #: 35RC17_8996_HemaSur
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Adrenal Insufficiency
• Haematological Malignancy
• Hematologic Neoplasms

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