Back to resultsPPI Versus Histamine Antagnists as Adjuvant to Chemotherapy
Primary Purpose
Lymphoma
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
CHOP
CHOP Plus Lanzoprazole
CHOP Plus Famotidine
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma
Eligibility Criteria
Inclusion Criteria:
- DLBCL Lymphoma subtype --No comorbid disease
Exclusion Criteria:
- Pregnancy
- Peptic ulcer
- Severe cardiac disease
- Osteoporosis
Sites / Locations
- Sherief Abd-ElsalamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
CHOP
CHOP Plus Lanzoprazole
CHOP Plus Famotidine
Arm Description
CHOP only
CHOP Plus Lanzoprazole 60 mg
CHOP Plus Famotidine 40 mg
Outcomes
Primary Outcome Measures
Number of patients eith radiological and clinical improvement
Number of patients eith radiological and clinical improvement after cycles of chemotherapy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03647072
Brief Title
PPI Versus Histamine Antagnists as Adjuvant to Chemotherapy
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
October 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherief Abd-Elsalam
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
The study is a Comparative Clinical and Biochemical Study Evaluating the effect of Proton Pump Inhibitors versus histamine 2 Receptor antagonists as an adjuvant with chemotherapy in patients with Non-hodgkin Lymphoma to compare the difference in efficacy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CHOP
Arm Type
Active Comparator
Arm Description
CHOP only
Arm Title
CHOP Plus Lanzoprazole
Arm Type
Active Comparator
Arm Description
CHOP Plus Lanzoprazole 60 mg
Arm Title
CHOP Plus Famotidine
Arm Type
Active Comparator
Arm Description
CHOP Plus Famotidine 40 mg
Intervention Type
Drug
Intervention Name(s)
CHOP
Other Intervention Name(s)
CHOP protocol
Intervention Description
CHOP only
Intervention Type
Drug
Intervention Name(s)
CHOP Plus Lanzoprazole
Other Intervention Name(s)
CHOP Plus Lanzoprazole 60
Intervention Description
CHOP plus Lanzoprazole 60 mg
Intervention Type
Drug
Intervention Name(s)
CHOP Plus Famotidine
Other Intervention Name(s)
CHOP Plus Famotidine 40
Intervention Description
CHOP Plus Famotidine 40 mg
Primary Outcome Measure Information:
Title
Number of patients eith radiological and clinical improvement
Description
Number of patients eith radiological and clinical improvement after cycles of chemotherapy
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
DLBCL Lymphoma subtype --No comorbid disease
Exclusion Criteria:
Pregnancy
Peptic ulcer
Severe cardiac disease
Osteoporosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, MD
Phone
00201147773440
Email
sheriefabdelsalam@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahar K Hegazy, Prof
Organizational Affiliation
Clinical pharmacy Department- Tanta University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sahar M El-Haggar, prof
Organizational Affiliation
Clinical pharmacy Department- Tanta University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Suzan A Alhassanin, Ph D
Organizational Affiliation
Clinical Oncology Department-Menoufia University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eman I A El berri, Msc
Organizational Affiliation
Clinical pharmacy Department-Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sherief Abd-Elsalam
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief Abd-elsalam, lecturer
Phone
00201000040794
Email
Sherif_tropical@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33394214
Citation
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.
Results Reference
derived
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PPI Versus Histamine Antagnists as Adjuvant to Chemotherapy
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