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PPI Versus Histamine Antagnists as Adjuvant to Chemotherapy

NCT ID: NCT03647072

Last Updated: 2018-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CHOP

CHOP only

Group Type ACTIVE_COMPARATOR

CHOP

Intervention Type DRUG

CHOP only

CHOP Plus Lanzoprazole

CHOP Plus Lanzoprazole 60 mg

Group Type ACTIVE_COMPARATOR

CHOP Plus Lanzoprazole

Intervention Type DRUG

CHOP plus Lanzoprazole 60 mg

CHOP Plus Famotidine

CHOP Plus Famotidine 40 mg

Group Type ACTIVE_COMPARATOR

CHOP Plus Famotidine

Intervention Type DRUG

CHOP Plus Famotidine 40 mg

Interventions

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CHOP

CHOP only

Intervention Type DRUG

CHOP Plus Lanzoprazole

CHOP plus Lanzoprazole 60 mg

Intervention Type DRUG

CHOP Plus Famotidine

CHOP Plus Famotidine 40 mg

Intervention Type DRUG

Other Intervention Names

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CHOP protocol CHOP Plus Lanzoprazole 60 CHOP Plus Famotidine 40

Eligibility Criteria

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Inclusion Criteria

* DLBCL Lymphoma subtype --No comorbid disease

Exclusion Criteria

* Pregnancy
* Peptic ulcer
* Severe cardiac disease
* Osteoporosis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sherief Abd-Elsalam

OTHER

Sponsor Role lead

Responsible Party

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Sherief Abd-Elsalam

PhDTropical Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sahar K Hegazy, Prof

Role: PRINCIPAL_INVESTIGATOR

Clinical pharmacy Department- Tanta University

Sahar M El-Haggar, prof

Role: STUDY_DIRECTOR

Clinical pharmacy Department- Tanta University

Suzan A Alhassanin, Ph D

Role: STUDY_DIRECTOR

Clinical Oncology Department-Menoufia University

Eman I A El berri, Msc

Role: PRINCIPAL_INVESTIGATOR

Clinical pharmacy Department-Tanta University

Locations

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Sherief Abd-Elsalam

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sherief Abd-Elsalam, MD

Role: CONTACT

[email protected]
00201147773440

Facility Contacts

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Sherief Abd-elsalam, lecturer

Role: primary

[email protected]
00201000040794

References

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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.

Reference Type DERIVED
PMID: 33394214 (View on PubMed)

Other Identifiers

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eman elberry

Identifier Type: -

Identifier Source: org_study_id

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