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PPI Versus Histamine Antagnists as Adjuvant to Chemotherapy

Sponsor
Sherief Abd-Elsalam (Other)
Overall Status
Recruiting
CT.gov ID
NCT03647072
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
112
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Aug 1, 2018
Anticipated Primary Completion Date :
Oct 1, 2027
Anticipated Study Completion Date :
Dec 1, 2027

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients eith radiological and clinical improvement [6 months]

      Number of patients eith radiological and clinical improvement after cycles of chemotherapy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • DLBCL Lymphoma subtype --No comorbid disease
    Exclusion Criteria:

    • Pregnancy

    • Peptic ulcer

    • Severe cardiac disease

    • Osteoporosis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sherief Abd-Elsalam Cairo Egypt

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sherief Abd-Elsalam, PhDTropical Medicine, Tanta University
    ClinicalTrials.gov Identifier:
    NCT03647072
    Other Study ID Numbers:
    • eman elberry
    First Posted:
    Aug 27, 2018
    Last Update Posted:
    Aug 27, 2018
    Last Verified:
    Aug 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lymphoma
    Famotidine

    Study Results

    No Results Posted as of Aug 27, 2018