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Study to compare the effectiveness of Lotion and Calendula Cream versus Chamomile Cream in an attempt to prevent Skin Reactions in patients with Breast Cancer

Phase II randomized study to compare the Efficacy of Radiodermatitis Prophylaxis between Lotion and Calendula Cream versus Chamomile Cream in patients with Breast Neoplasia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-877t2w
Enrollment
Unknown
Registered
2020-03-10
Start date
2013-04-09
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

Breast neoplasm

Interventions

The study will be performed in a single institution, in female patients with breast cancer who will be submitted to adjuvant radiotherapy after conservative surgery in an attempt to prevent grade 2 ra
Radiation
Other
E02.186.775

Sponsors

Hospital de Amor de Barretos
Lead Sponsor
Hospital de Amor de Barretos
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Female gender; Ductal Carcinoma in situ or Invasive; Lobular Carcinoma Invasive. Clinical stages 0; I; II or III (annex 2). Karnofsky performance scale (KPS) greater than or equal to 70% (annex 3). Age 18 years or older. Free and Informed Consent Form (annex 4) signed by the patient consenting to undergo the study. Treatment with adjuvant radiotherapy with a total dose of 6000cGy and without treatment to the lymphatic drainage of the supra clavicular fossa.

Exclusion criteria

Exclusion criteria: Male gender; non-conservative surgery; patient with collagen vascular disease; previous treatment with radiotherapy for the respective breast cancer; previous burn at the tumor site. Patient with mental disability. Patients undergoing chemotherapy (QT), except hormone therapy with tamoxifen, anastrozole or letrozole and monoclonal antibody with trastuzumab.

Design outcomes

Primary

MeasureTime frame
Determine the effectiveness of the calendula cream or lotion in preventing radiodermatitis grade 2 and higher in patients with breast cancer, comparing them with patients using chamomile cream.

Secondary

MeasureTime frame
Observe the effectiveness of the treatments (Calendula Cream or Lotion versus Chamomile Cream), comparing the time until the occurrence of grade II radiodermatitis, adjusted with social-demographic and clinical characteristics.;Describe the toxic effects in each treatment. (eg allergic reactions).

Countries

Brazil

Contacts

Public ContactRubem Fernando Lellis Andrade

Hospital de Amor de Barretos

rubemlellis@gmail.com+55(17)36243900

Outcome results

None listed

Source: REBEC (via WHO ICTRP)