Effectiveness of an phythetapic in prevention and treatment of skin lesions caused by radiotherapy in patients with Head and Neck Cancer

Evaluating the efectiveness of calendula in the prevention and treatment of Head and Neck Radiodermatitis

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-237v4b

Enrollment

Unknown

Registered

2013-09-16

Start date

2011-10-03

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

Head and Neck Cancer

Interventions

The study consists of two arms (experimental and control): Experimental group: marigold use topically in the prevention and treatment of radiodermatitis

Control group: use essential fatty acids, for topical use in the prevention and treatment of radiodermatitis. Form ulitização product: the skin applications were made with a gauze soaked with the prod

Other

B01.650.940.800.575.100.100.141

Eligibility

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Age above 18 years,diagnosis of cancer and head and neck radiotherapy, intact skin and continuous in the head and neck, first day of radiotherapy (if new), patients with no previous history of radiotherapy in the same field / local radiation, Consent to participate in by signing the consent form (ICF).

Exclusion criteria

Exclusion criteria: Previous reports of allergic reaction in the use of one of the research products (essential fatty acids or marigold).

Design outcomes

Primary

Measure	Time frame
Development radiodermitis grade 1. Expected results: prove that Marigold is more effective than the essential fatty acids (EFA) in the prevention and treatment of radiodermitis in patients with head and neck cancer undergoing radiotherapy. The evaluation was according to the criteria of the Radiation Therapy Oncology Group (RTOG) which graduates from 0 to 4 with radiodermatitis. Radiodermatitis was assessed on the first day of radiotherapy, the five sessions and 30 days after the end of treatment, in order to observe its presence and evolution.;Outcomes observed: the degree radiodermitis 1 emerged from the tenth day of radiotherapy, with the highest incidence in the control group (AGE).	—

Measure

Time frame

Development radiodermitis grade 1. Expected results: prove that Marigold is more effective than the essential fatty acids (EFA) in the prevention and treatment of radiodermitis in patients with head and neck cancer undergoing radiotherapy. The evaluation was according to the criteria of the Radiation Therapy Oncology Group (RTOG) which graduates from 0 to 4 with radiodermatitis. Radiodermatitis was assessed on the first day of radiotherapy, the five sessions and 30 days after the end of treatment, in order to observe its presence and evolution.;Outcomes observed: the degree radiodermitis 1 emerged from the tenth day of radiotherapy, with the highest incidence in the control group (AGE).

—

Secondary

Measure	Time frame
Development radiodermitis grade 2, grade 3 or grade 4.;Outcomes observed: control group had a higher incidence of grade 2 radiodermitis compared with the experimental group.	—

Countries

Brazil

Contacts

Public ContactFranciane Schneider

Universidade Federal do Paraná - UFPR

franciane_06@yahoo.com.br41-3361-3768

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Mar 5, 2026