Efficacy of Doxycycline in the Treatment of Early Stages of Mycosis Fungoides

Lymphoma Clinical Trial

Official title:

Efficacy of Doxycycline in the Treatment of Early Stages of Mycosis Fungoides: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03454945
• Other study ID #: doxycycline
• Status: Recruiting
• Phase: Phase 3
• Start date: March 1, 2017
• Est. completion date: April 1, 2019

Study information

• Verified date: August 2018
• Source: Cairo University
• Contact: Hagar El Sayed, Master
• Phone: 01061248365
• Email: hgr_ntr[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Current study aims at assessing the efficacy of doxycycline as a potential treatment modality for early stages of MF.

Description:

Objectives

Objective is to evaluate the efficacy of doxycycline in treatment of early stages of mycosis fungoides (IA, IB and IIA) and to assess its apoptotic enhancing effect by studying the expression of BCL2 by the T lymphocytes.

Study Design

Randomized controlled trial

Population of study & disease condition

30 patients with early stage mycosis fungoides (Stage Ia,Ib and IIa)

Methodology in details

After signing an informed consent, each participant will be subjected to:

I. Baseline evaluation:

1. Baseline biopsy to document the current state of the disease and to assess immunohistochemically the expression of CD3 and Bcl2 by the lymphocytes.

2. Detailed history taking including onset, course, duration of the disease and history of any previous treatments used.

3. Detailed examination of skin lesions and scoring using:

• Modified Severity of Index Weighted Assessment (mSWAT)

• Composite Assessment of Index Lesion Severity (CAILS)

4. Pruritus scoring using a visual analog scale from 0-10, where 0=no pruritus and 10=worst imaginable pruritus

5. Photography

II. Treatment and dosing protocol:

Participants will be randomly allocated in either one of the treatment groups:

Group A: Will receive oral doxycycline in a dose of 200 mg daily for three months.

Group B: Will receive PUVA with dosing & increments according to the standard protocols of the Phototherapy Unit, Dermatology Department, Cairo University; 3 sessions per week for 3 months.

III. Timings of follow up visits and clinical assessments done:

Patients will be regularly assessed at weeks 4, 8, and 12. Patients continuing for another three months, as mentioned above, will be assessed at weeks 16, 20 and 24. The following will be done at these follow up visits: mSWAT, CAILS, pruritus scoring and photography. Side effects will be monitored and managed accordingly.

IV. Follow up biopsies:

A repeat biopsy will be taken at initial improvement in CAILS (or at week 12) for immunohistochemical re-assessment of the expression of CD3 and Bcl2 by the lymphocytes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults (above 18) of either sex with established diagnosis of classic MF

Exclusion Criteria:

• Any variant of MF other than the classic variant.

• Advanced stages of classic MF: Stage IIb, III or IV.

• Pregnant and lactating females.

• Patients with autoimmune diseases e.g. SLE

• Patients with solid or hematological malignancies e.g. breast cancer, leukemia, etc.

• Patients with any contraindications for doxycycline (eg: liver disease, kidney disease, photosensitivity, peptic ulcer or patients receiving systemic retinoids).

• Patients with any contraindication to phototherapy (eg: any other skin cancers or photosensitivity); or to psoralen (eg: liver disease)

Related Conditions & MeSH terms

• Lymphoma
• Mycoses
• Mycosis Fungoides

Intervention

Drug:
• Vibramycin
Antibiotic

Device:
• Phototherapy
UVA+Psoralen

Locations

Country	Name	City	State
Egypt	Dermatology departement	Cairo
Egypt	Dermatology department	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical assessment	Clinical assessment of the extent of the lesions in body surface area	3 months
Secondary	Pathological assessment	Pathological assessment using immunohistochemistry	3months