The effect of Calendula lotion in reducing the severity of radiation induced dermatitis in women undergoing radiotherapy for breast cancer

Phase 3

Completed

• Conditions: Radiation induced dermatitis; Breast cancer; Skin - Dermatological conditions; Cancer - Breast

• Registration Number: ACTRN12613000165785
• Lead Sponsor: Dr Michael Penniment

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 178

Inclusion Criteria

Women who have undergone lumpectomy or mastectomy and are due to undergo post-surgical radiotherapy for
breast cancer using standard treatment pathways
No concurrent chemotherapy
Informed consent

Exclusion Criteria

Known allergy to calendula/officinalis or sorbolene
Salicylate sensitivity
Previous radiation to breast
History of skin/dermatitis condition
On anticoagulant therapy
Pregnant or breast feeding
Reaction to skin test

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of radiation induced dermatitis will be assessed clinically and graded using the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC) acute radiation morbidity scale for skin. [Weekly throughout the active treatment (radiation) and at post-treatment follow-up at up to 6 weeks after conclusion of treatment]

Secondary Outcome Measures

Name	Time	Method
Radiation Induced Skin Reaction Assessment Scale Part A and Part B (RISRAS)[Weekly throughout the active treatment (radiation) and at post-treatment follow-up at up to 6 weeks after conclusion of treatment];Interruptions to treatment as documented by treating radiation oncologist on treatment plan[At any time through the active treatment (radiation)];Radiation Schedule (dose/fraction) as documented by radiotherapists on treatment plan[End of treatment follow-up review];Participant reported ease of application of topical lotion as assessed by investigator administered questionnaire[End of treatment follow-up review];Dermatis reaction to regularly applied topical lotion, judged by treating radiation oncologists to not be related to radiation therapy, as documented in treatment plan[Any stage throughout study]