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

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ClinicalTrials.gov Identifier: NCT01688479
Recruitment Status : Completed
First Posted : September 20, 2012
Last Update Posted : September 17, 2015
Sponsor:
Information provided by (Responsible Party):
Thomas Hatschek, Karolinska University Hospital

Brief Summary:

Acute radiation skin reactions (ARSR) occur in the majority of patients undergoing postoperative radiotherapy (RT). Some patients experience more severe reactions such as dry and/or moist desquamation but most patients experience mild reactions e.g. erythema (Lopez et al., 2005). The radiation dose, volume, RT technique and previous treatment, such as type of surgery and previous chemotherapy, are factors that might impact on the risk for ARSR together with patient-related factors such as body mass index (BMI), smoking status and previous skin damage (Porock et al., 1998; Wells et al., 2004). In a pilot study (n=93) of the frequency of ARSR in patients with breast cancer who underwent adjuvant RT it was shown that 93% developed ARSR, mostly mild reactions. Patients reported low scores on pain and itching (Sharp et al., 2011). Over 80% of the patients reported adherence to the skin care recommendations which included application of a thin layer of Essex® cream, a non-perfumed aqueous cream, on the irradiated area at least two times a day (Sharp et al., 2011). The effects of skin care products containing Calendula Officinalis (marigold plant) on ARSR in patients with breast cancer were investigated in a randomized clinical trial (Pommier et al., 2004). Patients in the experimental group, treated with calendula cream had a statistically significant lower incidence of severe ARSR, pain and treatment interruptions in comparison with the patients in the control group, treated with trolamine.

The purpose of this blinded, randomized clinical trial is to compare two topical agents, Calendula Weleda® cream and Essex® cream, in terms of efficacy to reduce the risk of severe acute radiation skin reactions (ARSR) in relation to adjuvant radiotherapy (RT) for breast cancer.

Patients were instructed to apply a thin layer of the assigned cream twice a day, starting at the onset of RT and continue until two weeks after termination, or until the ARSR is healed. The application should include the whole treatment area including the armpit and shoulder/back area in patients treated with modified radical mastectomy. Patients are also advised to not apply the cream within two hours before the RT in order to avoid possible build-up effect. Daily wash with perfume free soap and tap water are recommended and patients are advised to refrain from use of other topical agents in the irradiated area.

The primary endpoint is the efficacy to reduce acute radiation skin reactions (ARSR), assessed with the Radiation Therapy Oncology Group/The Organization for Research and Treatment of Cancer Acute Radiation Morbidity Scoring Criteria (RTOG/EORTC scale) at follow-up.

Secondary endpoints include patient reported outcome measures; Quality of Life Questionnaire (QLQ-C30), Sleep disturbances (MOS-sleep questionnaire) and symptoms experienced from the irradiated area (visual analogue scale). Patients' experiences and adherence to the topical agents are also evaluated.

A total of 400 patients are required to detect a true absolute reduction in the proportion of patients with ARSR, from 35% with standard treatment (Essex® cream) to 20% with the experimental treatment (Calendula Weleda® cream), with a significance level of 5% a power of 90%. With this sample size, 95% confidence intervals for the difference in proportions are estimated to be in the order of ±10%. Assuming a rate of 5% of non-responders, the target size has been set to 420 patients.


Condition or disease Intervention/treatment Phase
Postoperative Radiotherapy Breast Cancer 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 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Calendula Weleda® cream (Weleda)
Calendula Officinalis (marigold plant) is applied twice daily on the skin in the radiated area during the entire treatment period and until the skin reaction subsided
Drug: Calendula Weleda cream (Weleda AG, Sweden) contains extracts of marigold plant (Calendula Officinalis 10%), wool fat and sesame oil
Active Comparator: Essex® cream (Schering-Plough)
Essex cream is applied twice daily on the skin in the radiated area during the entire treatment period and until the skin reaction subsided
Drug: Essex® cream (Schering-Plough), aqueous cream without parabens



Primary Outcome Measures :
  1. Grade of skin reactions to radiotherapy [ Time Frame: 8 weeks ]
    Skin reactions due to radiotherapy using RTOG scale


Secondary Outcome Measures :
  1. Quality of life in relation to skin reaction [ Time Frame: 8 weeks ]
    Measurements of sleep disturbances acc. to the MOS-SLEEP scale and QoL acc. to EORTC QLQ-C30


Other Outcome Measures:
  1. Impact of smoking habits on the intensity of the skin reaction [ Time Frame: 8 weeks ]
    Collection of data on smoking habits and measurements of carbon monoxide in exhaled air



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01688479


Locations
Sweden
Department of Oncology, Karolinska University Hospital
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska University Hospital
Investigators
Principal Investigator: Maria AC Bergenmar, PhD Dept of Oncology, Karolinska University Hospital, Stockholm, Sweden
Principal Investigator: Lena Sharp, PhD Dept of Oncology, Karolinska University Hospital, Stockholm, Sweden
Study Chair: Thomas Hatschek, MD, PhD Dept of Oncology, Karolinska University Hospital, Stockholm, Sweden

Publications of Results:
Responsible Party: Thomas Hatschek, MD, PhD, Assoc. prof., Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01688479     History of Changes
Other Study ID Numbers: Calendula trial
First Posted: September 20, 2012    Key Record Dates
Last Update Posted: September 17, 2015
Last Verified: September 2015

Keywords provided by Thomas Hatschek, Karolinska University Hospital:
Postoperative radiotherapy
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases