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PPI Versus Histamine Antagnists as Adjuvant to Chemotherapy

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ClinicalTrials.gov Identifier: NCT03647072
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

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.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: CHOP Drug: CHOP Plus Lanzoprazole Drug: CHOP Plus Famotidine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : October 2027
Estimated Study Completion Date : December 2027


Arm Intervention/treatment
Active Comparator: CHOP
CHOP only
Drug: CHOP
CHOP only
Other Name: CHOP protocol

Active Comparator: CHOP Plus Lanzoprazole
CHOP Plus Lanzoprazole 60 mg
Drug: CHOP Plus Lanzoprazole
CHOP plus Lanzoprazole 60 mg
Other Name: CHOP Plus Lanzoprazole 60

Active Comparator: CHOP Plus Famotidine
CHOP Plus Famotidine 40 mg
Drug: CHOP Plus Famotidine
CHOP Plus Famotidine 40 mg
Other Name: CHOP Plus Famotidine 40




Primary Outcome Measures :
  1. Number of patients eith radiological and clinical improvement [ Time Frame: 6 months ]
    Number of patients eith radiological and clinical improvement after cycles of chemotherapy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DLBCL Lymphoma subtype --No comorbid disease

Exclusion Criteria:

  • Pregnancy
  • Peptic ulcer
  • Severe cardiac disease
  • Osteoporosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647072


Contacts
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Contact: Sherief Abd-Elsalam, MD 00201147773440 sheriefabdelsalam@yahoo.com

Locations
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Egypt
Sherief Abd-Elsalam Recruiting
Cairo, Egypt
Contact: Sherief Abd-elsalam, lecturer    00201000040794    Sherif_tropical@yahoo.com   
Sponsors and Collaborators
Sherief Abd-Elsalam
Investigators
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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

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Responsible Party: Sherief Abd-Elsalam, PhDTropical Medicine, Tanta University
ClinicalTrials.gov Identifier: NCT03647072     History of Changes
Other Study ID Numbers: eman elberry
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Histamine
Histamine phosphate
Famotidine
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists