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Effect of a chitosan-chamomilla microparticle formulation in the prevention of radiation dermatitis

Effect of a chitosan-chamomilla microparticle formulation in the prevention of radiation dermatitis: a randomized controlled phase II clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-9hnftg
Enrollment
Unknown
Registered
2019-08-26
Start date
2019-01-23
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiodermatitis

Interventions

Experimental group: A group of 53 women with breast cancer will receive topical application of the moisturizing formulation with chamomile microparticles once a day after radiotherapy throughout the t

Sponsors

Escola de Enfermagem de Ribeirão Preto da Universidade de São Paulo
Lead Sponsor
Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 18 years older; confirmed diagnosis of breast cancer; indication of radiotherapy treatment; Not having started radiation therapy; non-history of allergic reactions to any other component of chamomile or lanolin; non-history of allergic reactions to fish, shrimp or seafood; Kanofsky greater than 70; No use of systemic corticosteroids. do not use heparin, oral anticoagulants and antiplatelet agents.

Exclusion criteria

Exclusion criteria: Present any injury at the treatment site; present skin involvement by the tumor;

Design outcomes

Primary

MeasureTime frame
It is expected to find an increase in time for appearance of grade I radiodermatitis during radiotherapy, clinically evaluated by the RTOG scale of toxicity.;It is expected to find an improvement in skin-related quality of life during treatment, assessed using the Skin-index instrument.;It is expected to find a reduction in the number of patients with grade II, III and IV radiodermatitis during radiotherapy, clinically evaluated by the RTOG scale of toxicity.

Secondary

MeasureTime frame
Secondary outcomes are not expected;Secondary outcomes are not expected

Countries

Brazil

Contacts

Public ContactDanielle Garbuio

Escola de Enfermagem de Ribeirão Preto da Universidade de São Paulo

dgarbuio@yahoo.com.br+55 016 3602-2632

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 12, 2026