PPI Versus Histamine Antagnists as Adjuvant to Chemotherapy
Comparative Clinical and Biochemical Study Evaluating the Effect of Proton Pump I Nhibitors Versus Histamine 2 Receptor Antagonists as an Adjuvant With Chemotherapy in Patients With Non-hodgkin Lymphoma.
1 other identifier
interventional
60
1 country
1
Brief Summary
The study is a Comparative Clinical and Biochemical Study Evaluating the effect of Proton Pump I nhibitors versus histamine 2 Receptor antagonists as an adjuvant with chemotherapy in patients with Non-hodgkin Lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 lymphoma
Started Aug 2018
Typical duration for phase_3 lymphoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2018
CompletedFirst Submitted
Initial submission to the registry
August 23, 2018
CompletedFirst Posted
Study publicly available on registry
August 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
August 27, 2018
August 1, 2018
9.2 years
August 23, 2018
August 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients eith radiological and clinical improvement
Number of patients eith radiological and clinical improvement after cycles of chemotherapy
6 months
Study Arms (3)
CHOP
ACTIVE COMPARATORCHOP only
CHOP Plus Lanzoprazole
ACTIVE COMPARATORCHOP Plus Lanzoprazole 60 mg
CHOP Plus Famotidine
ACTIVE COMPARATORCHOP Plus Famotidine 40 mg
Interventions
CHOP plus Lanzoprazole 60 mg
CHOP Plus Famotidine 40 mg
Eligibility Criteria
You may qualify if:
- DLBCL Lymphoma subtype --No comorbid disease
You may not qualify if:
- Pregnancy
- Peptic ulcer
- Severe cardiac disease
- Osteoporosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sherief Abd-Elsalam
Cairo, Egypt
Related Publications (1)
Hegazy SK, El-Haggar SM, Alhassanin SA, El-Berri EI. Comparative randomized trial evaluating the effect of proton pump inhibitor versus histamine 2 receptor antagonist as an adjuvant therapy in diffuse large B-cell lymphoma. Med Oncol. 2021 Jan 4;38(1):4. doi: 10.1007/s12032-020-01452-z.
PMID: 33394214DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sahar K Hegazy, Prof
Clinical pharmacy Department- Tanta University
- STUDY DIRECTOR
Sahar M El-Haggar, prof
Clinical pharmacy Department- Tanta University
- STUDY DIRECTOR
Suzan A Alhassanin, Ph D
Clinical Oncology Department-Menoufia University
- PRINCIPAL INVESTIGATOR
Eman I A El berri, Msc
Clinical pharmacy Department-Tanta University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- PhDTropical Medicine
Study Record Dates
First Submitted
August 23, 2018
First Posted
August 27, 2018
Study Start
August 1, 2018
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
August 27, 2018
Record last verified: 2018-08