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

NCT03688789 | Withdrawn

• 1 other identifier: 35RC17_8996_HemaSur
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Haematological Malignancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• cumulative doses of corticosteroids in prednisone equivalent as well as duration of exposure

  6 months

• potential drug interactions (including CYP450 inducer)

  6 months

• 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

Study Arms (1)

Hydrocortisone supplementation

EXPERIMENTAL

Other: Hydrocortisone supplementation

Interventions

Hydrocortisone supplementation OTHER

* 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

Hydrocortisone supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Brieuc Cherel, MD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 28, 2018
• Study Start: January 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: December 1, 2022
• Last Updated: March 31, 2023

Record last verified: 2023-03