NCT03941665

Brief Summary

The aim of the study is to evaluate the effect of Gelronate gel, NaHA based product (medical device for topical application) vs. Aloevera gel, in prevention or minimizing of radiation induced skin reaction in breast cancer patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 2, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 8, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2020

Completed
Last Updated

December 3, 2020

Status Verified

December 1, 2019

Enrollment Period

1.1 years

First QC Date

May 2, 2019

Last Update Submit

December 2, 2020

Conditions

Radiation Dermatitis

Outcome Measures

Primary Outcomes (3)

  • Development and degree of any skin reaction

    Grading according to Radiation Toxicity Grading (RTOG) skin toxicity score. Full scale of RTOG is 0 (no change over baseline) to 4 (ulceration, hemorrhage, necrosis).

    4 weeks

  • Development and degree of any skin reaction

    Assessment of skin reaction by scoring of weekly digital photographs

    4 weeks

  • Development and degree of any skin reaction

    Patient comfort assessed by weekly administrated questionnaire. Scores are between 1 (nothing) to 4 (all over the breast)

    4 weeks

Secondary Outcomes (1)

  • Skin reaction requiring conventional topical therapy

    4 weeks

Study Arms (2)

Gelronate

EXPERIMENTAL

Tested new medical device

Device: GelronateOther: Aloevera

Aloevera

ACTIVE COMPARATOR

Current product used by the medical center

Device: GelronateOther: Aloevera

Interventions

GelronateDEVICE

Gel for topical use

AloeveraGelronate
AloeveraOTHER

Gel for topical use

AloeveraGelronate

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients aged at least 18 years with unilateral breast following lumpectomy +/- chemotherapy
  • Planned to receive 42.4 Gy whole breast irradiation +/- boost to tumor bed.
  • ECOG performance status 0-2.
  • Capable of giving written informed consent.
  • No co-morbidities known to affect radiotherapy reactions.
  • No co-existing acute or chronic skin disease.
  • No evidence of infection or inflammation of breast to be treated.
  • Not receiving chemotherapy during radiotherapy course. Biological therapy (e.g. Herceptin) or hormone therapy will be allowed during the study.

You may not qualify if:

  • Chemotherapy within 4 weeks prior to planned start of radiation or chemotherapy planned during radiation.
  • Prior radiotherapy to the chest wall.
  • Collagen vascular disease.
  • Participation in other clinical study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, 5265601, Israel

Location

Related Publications (2)

  • Primavera G, Carrera M, Berardesca E, Pinnaro P, Messina M, Arcangeli G. A double-blind, vehicle-controlled clinical study to evaluate the efficacy of MAS065D (XClair), a hyaluronic acid-based formulation, in the management of radiation-induced dermatitis. Cutan Ocul Toxicol. 2006;25(3):165-71. doi: 10.1080/15569520600860009.

    PMID: 16980242RESULT

  • Leonardi MC, Gariboldi S, Ivaldi GB, Ferrari A, Serafini F, Didier F, Mariani L, Castiglioni S, Orecchia R. A double-blind, randomised, vehicle-controlled clinical study to evaluate the efficacy of MAS065D in limiting the effects of radiation on the skin: interim analysis. Eur J Dermatol. 2008 May-Jun;18(3):317-21. doi: 10.1684/ejd.2008.0396. Epub 2008 May 13.

    PMID: 18474463RESULT

MeSH Terms

Conditions

Radiodermatitis

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesRadiation InjuriesWounds and Injuries

Study Officials

  • Ofer S Dubinsky, Ph.D.

    Ferring Holding Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double blind study
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Double blind study
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2019

First Posted

May 8, 2019

Study Start

March 25, 2019

Primary Completion

May 1, 2020

Study Completion

May 3, 2020

Last Updated

December 3, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)