PPI Versus Histamine Antagnists as Adjuvant to Chemotherapy

August 23, 2018 updated by: Sherief Abd-Elsalam

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Sherief Abd-Elsalam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • DLBCL Lymphoma subtype --No comorbid disease

Exclusion Criteria:

  • Pregnancy
  • Peptic ulcer
  • Severe cardiac disease
  • Osteoporosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CHOP
CHOP only
Drug: CHOP
CHOP only
Other Names:
  • CHOP protocol
Active Comparator: CHOP Plus Lanzoprazole
CHOP Plus Lanzoprazole 60 mg
Drug: CHOP Plus Lanzoprazole
CHOP plus Lanzoprazole 60 mg
Other Names:
  • CHOP Plus Lanzoprazole 60
Active Comparator: CHOP Plus Famotidine
CHOP Plus Famotidine 40 mg
Drug: CHOP Plus Famotidine
CHOP Plus Famotidine 40 mg
Other Names:
  • CHOP Plus Famotidine 40

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients eith radiological and clinical improvement
Time Frame: 6 months
Number of patients eith radiological and clinical improvement after cycles of chemotherapy
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sherief Abd-Elsalam

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Anticipated)

October 1, 2027

Study Completion (Anticipated)

December 1, 2027

Study Registration Dates

First Submitted

August 23, 2018

First Submitted That Met QC Criteria

August 23, 2018

First Posted (Actual)

August 27, 2018

Study Record Updates

Last Update Posted (Actual)

August 27, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • eman elberry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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