Clinical trial NCT03454945: Efficacy of Doxycycline in the Treatment of Early Stages of Mycosis Fungoides
Official title: Efficacy of Doxycycline in the Treatment of Early Stages of Mycosis Fungoides: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Lymphoma
Keywords: Mycosis fungoides
Doxycycline
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-03-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Clinical assessment
timeFrame: 3 months
Secondary outcomes:
measure: Pathological assessment
timeFrame: 3months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Dermatology departement
city: Cairo
country: Egypt
facility: Dermatology department
Study officials:
affiliation: Cairo University
name: Mona AbdEl Halim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.
citation: El Sayed H, Shalaby S, Abdel-Halim MRE, Aboelfadl DM, Samir N. Efficacy of doxycycline in the treatment of early stages of mycosis fungoides: a randomized controlled trial. J Dermatolog Treat. 2021 Jun;32(4):424-431. doi: 10.1080/09546634.2019.1667474. Epub 2019 Sep 20.