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Randomized, Blinded Phase III Trial Comparing Calendula Officinalis Cream With Standard Aqueous Cream "Essex" for Treatment of Skin Reactions Caused by Postoperative Radiotherapy of Breast Cancer


Phase 3
18 Years
N/A
Not Enrolling
Female
Postoperative Radiotherapy of Breast Cancer

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Trial Information

Randomized, Blinded Phase III Trial Comparing Calendula Officinalis Cream With Standard Aqueous Cream "Essex" for Treatment of Skin Reactions Caused by Postoperative Radiotherapy of Breast Cancer


Inclusion Criteria:



- radically operated for breast cancer,

- aged 18 years or older,

- signed informed consent

Exclusion Criteria:

- previous radiation in the same area,

- severe general health problems,

- ECOG performance status > 3,

- reduced cognitive ability,

- allergy to marigold plant

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Grade of skin reactions to radiotherapy

Outcome Description:

Skin reactions due to radiotherapy using RTOG scale

Outcome Time Frame:

8 weeks

Safety Issue:

No

Principal Investigator

Maria AC Bergenmar, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dept of Oncology, Karolinska University Hospital, Stockholm, Sweden

Authority:

Sweden: Medical Products Agency

Study ID:

Calendula trial

NCT ID:

NCT01688479

Start Date:

February 2011

Completion Date:

September 2012

Related Keywords:

  • Postoperative Radiotherapy of Breast Cancer
  • Postoperative radiotherapy
  • breast cancer
  • Breast Neoplasms

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