Clinical TrialID 445

Trial Comparing Calendula Officinalis With Aqueous Cream "Essex" to Treat Skin Reactions From Radiotherapy of Breast Cancer

NCT01688479

Postoperative Radiotherapy Breast Cancer

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Trial: 1Herb: 1Links: 1
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Record Fields

Scalar fields from the final clinical_trial record.

Clinical Trial Id
445
Evidence Id
445
Core Evidence Id
445
Source Clinical Trial Id
431
Herb2 Clinical Trial Id
HBCT000431
Nct Id
NCT01688479
Title
Trial Comparing Calendula Officinalis With Aqueous Cream "Essex" to Treat Skin Reactions From Radiotherapy of Breast Cancer
Status
Completed
Phase
Phase 3
Study Result
No
Study Condition
Postoperative Radiotherapy Breast Cancer
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Intervention
DRUG: Calendula Weleda cream (Weleda AG, Sweden) contains extracts of marigold plant (Calendula Officinalis 10%), wool fat and sesame oil|DRUG: Essex® cream (Schering-Plough), aqueous cream without parabens
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Quadruple
Intervention Purpose
Treatment
Gender
Female
Age
Adult, Older_Adult
Enrollment
420
Outcome Measure
Grade of skin reactions to radiotherapy, Skin reactions due to radiotherapy using RTOG scale, 8 weeks
Sponsor Collaborator
Karolinska University Hospital
Funded By
OTHER
Location
Department of Oncology, Karolinska University Hospital, Stockholm, 17176, Sweden
Other Id
Calendula trial
Start Date
2011-02
Primary Completion Date
2012-03
Completion Date
2012-09
First Posted
2012-09-20
Results First Posted
Last Update Posted
2015-09-17
Study Document
Study Url
https://clinicaltrials.gov/study/NCT01688479
Title Cn
Title En
Trial Comparing Calendula Officinalis With Aqueous Cream "Essex" to Treat Skin Reactions From Radiotherapy of Breast Cancer
Bilingual Status
semi_complete