Calendula

Calendula

PEP Topic 
Radiodermatitis
Description 

Calendula (Calendula officinalis) is a perennial herb in the daisy family and is used topically as a tincture or cream. Calendula contains high amounts of flavonoids, plant-based antioxidants that protect the body against cell-damaging free radicals. It seems to have anti-inflammatory, antiviral, and antibacterial effects, as well as healing properties. The healing properties are believed to occur because of increased blood flow to the affected area. Calendula is also available to take orally. Calendula can cause an allergic reaction in people sensitive to ragweed and similar plants.

Likely to Be Effective

Guideline/Expert Opinion

Bolderston, A., Lloyd, N.S., Wong, R.K.S., Holden, L., Robb-Blenderman, L., & Supportive Care Guidelines Group. (2005). The prevention and management of acute skin reactions related to radiation therapy: A clinical practice guideline (Practice Guidelines Report #13-7). Toronto, Canada: Cancer Care Ontario. Retrieved from https://www.cancercare.on.ca/common/pages/UserFile.aspx?fileId=34406.

Print

Purpose & Patient Population:

To develop practice guidelines answering two questions:

  1. What are the optimal methods to prevent acute skin reactions related to radiation therapy (RT) within the first six months of irradiation?
  2. What are the optimal methods to manage acute skin reactions related to RT?

Type of Resource/Evidence-Based Process:

Databases searched were PreMEDLINE, MEDLINE, CANCERLIT, and Cochrane Library between January 1980 and April 2004. The name of the initiative was the Cancer Care Ontario’s Program in Evidence-Based Care. The method used was the practice guidelines development cycle. Articles were included based on rigorous inclusion criteria (meta-analysis, systematic reviews, evidence-based practice guidelines, comparative studies, prospectively collected data in at least one trial arm, studies with reported outcomes—degree of skin reaction [using a validated skin reaction tool] and other outcomes reported and articles available as published articles or abstract reports). Exclusion criteria were also identified.

The systematic review included interprofessional members from the Supportive Care Guidelines Group of Cancer Care Ontario and the Program in Evidence-Based Care, an internationally recognized program at McMaster University, Hamilton, Ontario, Canada.

No conflict of interest was identified.

A systematic review of 28 clinical trials was included in analyses; 23 pertained to prevention and 5 addressed management of skin reactions. Two practice guides were reviewed:  Oncology Nursing Society and British Columbia Cancer Agency (expert opinion and consensus).

Results Provided in the Reference:

A table of clinical studies presented study descriptions and outcomes of the trials on prevention and management of skin reactions, pain, and itching.

The largest randomized trial compared calendula versus Biafine and was significant (p = 0.03) in reducing the severity of RT dermatitis.

Guidelines & Recommendations:

  • Gentle skin washing with water alone or mild soap (unscented, lanolin-free) and water
  • Gentle shampooing of the scalp with mild shampoo if receiving RT to the head
  • Encourage personal hygiene habits to avoid psychosocial distress. Limiting personal hygiene practices is not recommended.
  • Patients who received breast irradiation may use calendula ointment to decrease the occurrence of a grade 2 or higher skin reaction.

Nursing Implications:

Insufficient evidence existed to support or refute the use of

•Topical agents (corticosteroids, sucralfate cream, Biafine® (Ortho Dermatologics), ascorbic acid, aloe vera, chamomile cream, almond ointment, or polymer adhesive skin sealant)
•Oral agents (enzymes, sucralfate)
•Intravenous agents (amifostine)

Gentle skin and hair washing should be unrestricted in patients receiving RT. No barrier exists to using mild soap.

No trials answered the question on management.

Future Research:

  • Outcome assessment tools are required, including quality of life tools.
  • Trials to assess oral enzymes are needed to confirm studies showing potential for prevention benefit.
  • Randomized trials are needed (double-blinded, randomized, controlled trials) about the benefits of moisturizing cream as a preventive measure.
  • Randomized trials are needed that address moist desquamation management with the use of dressings as an intervention.
  • Trials are needed that explore sites with different risk factors and possible differing management.

Opinions of This Group:

  • Use plain, unscented, lanolin-free hydrophilic cream, but discontinue with skin breakdown.
  • Low-dose corticosteroid cream may be helpful with itching and irritation, but caution patients about overuse. More evidence is required to make firm recommendations.

Wong, R.K., Bensadoun, R.J., Boers-Doets, C.B., Bryce, J., Chan, A., Epstein, J.B., . . . Lacouture, M.E. (2013). Clinical practice guidelines for the prevention and treatment of acute and late radiation reactions from the MASCC Skin Toxicity Study Group. Supportive Care in Cancer, 21, 2933–2948. 

PROFESSIONAL GROUP: Multinational Association for Supportive Care in Cancer (MASCC) Skin Toxicity Study Group

doi: 10.1007/s00520-013-1896-2
Print

Purpose & Patient Population:

PURPOSE: To develop evidence-based guidelines to prevent and treat skin toxicity (acute and late) from radiation therapy. Use of these guidelines was intended for practitioners who encounter patients with skin changes associated with radiation therapy.
 
TYPES OF PATIENTS ADDRESSED: Patients who have received or will receive radiation therapy

Type of Resource/Evidence-Based Process:

RESOURCE TYPE: Evidence-based guideline
 
PROCESS OF DEVELOPMENT: The Skin Toxicity Study Group is one of 17 study groups of the Multinational Association for Supportive Care in Cancer (MASCC). The first original search was from 1980–2004 and was used by the Cancer Care Ontario guideline group. This search was updated in 2010 for a book chapter on radiation dermatitis, including the original search strategy from 1980–2004 in addition to a search without language restriction for 2004–August 2010. For the MASCC guideline, a second update from 2010–April 2011 was conducted for the meeting. A final update was completed in July 2012 prior to publication of the manuscript.

DATABASES USED: MEDLINE for initial and subsequent updates; PreMEDLINE, Cochrane Library, and CANCERLIT for the original search 1980–2004; Embase for 2010–2012; and conference proceedings of the American Society of Clinical Oncology for 2004–2012. National Guidelines Clearinghouse was used for existing practice guidelines.

KEYWORDS: Radiation dermatitis for acute reactions; telangiectasia and cutaneous fibrosis for late reactions

INCLUSION CRITERIA: Randomized controlled trials, guideline papers, meta-analyses, and systematic reviews. Studies that included any control group met the definition of a controlled study. Inclusion required that grade of skin reaction was evaluated as an outcome with primary interest greater or equal to moist desquamation. Pain, itching, and quality of life also were included if available. For late reaction dermatitis, trials using prospective designs were used.

EXCLUSION CRITERIA: Unpublished articles

Phase of Care and Clinical Applications:

PHASE OF CARE: Multiple phases of care

Results Provided in the Reference:

Acute radiation dermatitis recommendations were based on guidelines consisting of four general systematic reviews, two for specific topics, two evidence-based guidelines, and one consensus guideline. There were 56 randomized controlled trials–45 prevention, 9 treatment, and 1 combined prevention and treatment. Late radiation effect recommendations were based on one RCT; one prospective, observational study; and two prospective, single-arm studies.

Guidelines & Recommendations:

Strong recommendation:
  • Gentle washing with water (mild soap or shampoo optional)
  • Antiperspirants during breast radiation therapy
  • Prophylactic topical steroids (mometasone) for risk reduction of discomfort and itching
 
Weak recommendation:
  • Prophylactic silver sulfadiazine cream in patients with breast cancer to reduce radiation dermatitis score
 
Strong recommendation against:
  • Prophylactic aloe vera or trolamine
 
No recommendation possible:
  • Prophylactic topical sulcrate/derivatives, hyaluronic acid, ascorbic acid, silver leaf dressing, LED, Theta-Cream, dexpanthenol, and calendula
  • Oral proteolytic enzymes, sucralfate, zinc, and pentoxifylline in standard clinical practice
 
Established radiation-induced telangiectasia and fibrosis:
  • Weak recommendation for pulse dye laser for visual appearance
  • Weak recommendation against pentoxifylline for reduction of fibrosis in standard clinical practice
 
Patient education materials:
  • Validation prior to use
  • Sixth grade reading level and tables preferred
  • Specific products to purchase with examples
  • Behaviors to avoid
  • Contact information for physician and when to call for symptom management

Nursing Implications:

Nurses need to keep updated on current studies and guidelines related to care of patients receiving radiation therapy as well as potential acute and long-term effects to the skin. Nurses are in a unique position to educate staff and patients on evidenced-based skin care. Potential skin care practices for patients undergoing radiation need to be evaluated through well-designed research studies.

Systematic Review/Meta-Analysis

Kumar, S., Juresic, E., Barton, M., & Shafiq, J. (2010). Management of skin toxicity during radiation therapy: a review of the evidence. Journal of Medical Imaging and Radiation Oncology, 54, 264–279.

doi: 10.1111/j.1754-9485.2010.02170.x
Print

Purpose:

To review the evidence for skin care management and conduct a survey to assess current practices in Australia and New Zealand.

Search Strategy:

Databases searched were MEDLINE, PubMed, CINAHL, Google Scholar, and Google search. Searches were also completed by hand for the time period of 1980 to 2008.

Search keywords were radiation dermatitis, skin reaction, management, skin care, skin toxicity, moist desquamation, dry desquamation, erythema, sorbolene aqueous cream, and aloe vera.

Inclusion and exclusion criteria were not specified.

Literature Evaluated:

Thirty-one references were retrieved. Literature was evaluated on the basis of sample size. Meta-analysis was performed on studies reporting at least grade II skin toxicity.

Sample Characteristics:

  • The final number of studies included was 31.
  • The sample size across studies was 3,174 participants (range 413–506).
  • Participants had various tumor types.
  • All participants received radiation therapy (RT).

Phase of Care and Clinical Applications:

Patients were undergoing the active antitumor treatment phase of care.

Results:

Findings were reviewed for washing, topical aloe vera, topical sucralfate, Biafine cream, corticosteroids, hyaluronic acid, barrier film, dressings, and wheatgrass extract for prophylaxis. For management, interventions included were topical steroid cream, sucralfate, and dressings. Meta-analysis across studies using any topical prophylaxis showed that any intervention was associated with lower odds of development of skin toxicity (p = 0.02). There were no significant results for management interventions. There was consistent evidence in favor of gentle washing with mild soap during RT. There was some evidence in support of corticosteroids, bepanthan, topical hyaluronic acid, calendula, and barrier films. Aloe vera was associated with higher toxicity.

Conclusions:

Evidence did not support the use of sucralfate, Biafine, or dressing for prevention. Evidence regarding interventions for management of skin toxicity was conflicted, and none produced significant effects. Findings support the use of washing. There was some evidence in support of using corticosteroids, bepanthan, barrier films, calendula, and topical hyaluronic acid. Findings suggest that use of any topical therapy for prophylaxis may be more effective than no intervention.

Limitations:

  • Analysis was limited by combining all types of interventions together, which did not allow for differentiation between those agents individually shown to be effective and not effective.
  • Methods for evaluation of the quality of the research were not well described or incorporated into the analysis. 
  • Findings regarding management were questionable because of high heterogeneity among studies included in the meta-analysis. 
  • Actual odds ratios or effect sizes from the meta-analysis were not reported. 
  • Final recommendations stated by the authors were not consistent with the rest of the conclusions stated elsewhere in the article. 
  • The basis for recommendations, concerning evaluation of the quality of the evidence, was not clear. 
  • The authors stated that they weighted studies by sample size, but this method was not described.

Nursing Implications:

Washing during RT should not be restricted. There is some evidence in support of using calendula, hyaluronic acid, no-sting barrier film, bepanthan, and topical steroids. Evidence does not support the use of aloe vera.

Research Evidence Summaries

Pommier, P., Gomez, F., Sunyach, M.P., D’Hombres, A., Carrie, C., & Montbarbon, X. (2004). Phase III randomized trial of calendula officinalis compared with trolamine for the prevention of acute dermatitis during irradiation for breast cancer. Journal of Clinical Oncology, 22(8), 1447–1453.

doi: 10.1200/JCO.2004.07.063
Print

Study Purpose:

To assess effectiveness of calendula for prevention of acute radiation-induced dermatitis of grade 2 or higher during radiation therapy compared with trolamine

Intervention Characteristics/Basic Study Process:

Patients were randomly allocated to application of trolamine or calendula on irradiated fields after each session. Patients started topical application of ointment at onset of radiation therapy, twice a day or more, depending on occurrence of dermatitis and pain, until completion. Patients were instructed not to use the agent two hours or less before an irradiation session or before treatment evaluation. No other prophylactic creams, lotions, or gels were allowed. Physicians were free to treat established dermatitis grade 2 or higher or allergy as considered appropriate. Clinicians were blinded to the treatment used

Sample Characteristics:

  • The study sample was comprised of 254 female patients who were randomized to trolamine (n = 128) or calendula (n = 126) treatment.
  • Age ranged from 26.5–74.5 years; mean age was 56.5 years in calendula arm and 55.1 years in trolamine arm.
  • All patients were post-lumpectomy or post-mastectomy for nonmetastatic breast cancer.
  • Patients received treatment with or without adjuvant postoperative chemotherapy or hormonal treatment.
  • Standard irradiation fractionation (2 Gy per session, five sessions per week) was used.

Setting:

The study took place at Centre Leon Berard in Lyon, France.

Study Design:

The study used a randomized, blinded controlled trial design.

Measurement Instruments/Methods:

  • Acute dermal toxicity was evaluated according to the Radiation Therapy Oncology Group scale.
  • Pain was assessed weekly on a 10 cm visual analog scale.
  • The occurrence, duration, and reasons for interruption of radiation therapy or of allocated cream application were registered, as were allergic reactions and quantity of agents used.
  • At the end of the study, patients completed a questionnaire to assess satisfaction with ease of application, pain, and dermatitis relief.
  • Qualitative measures were compared using Chi Square or Fisher’s exact test, as appropriate.
  • For quantitative measures, the Student’s t test or Wilcoxon-Mann-Whitney tests were used.

Results:

The occurrence of acute dermatitis of grade 2 or higher was significantly lower (41% versus 63%; p < .001) with use of calendula versus trolamine. Benefits were most marked at sites at risk of maceration (submammary fold, armpit, and tangential area) and sites with thin skin. Patients receiving calendula had less frequent interruption of radiation therapy. Mean length of treatment interruption was 10 days (range 2–22 days). Fifteen treatment interruptions were observed in trolamine group, 12 due to skin toxicity. No allergic reactions were observed in the calendula group, whereas four patients in the trolamine group developed allergic-type reactions of pruritus and urticaria. Patients receiving calendula had significantly reduced radiation-induced pain. Mean maximal pain evaluated in calendula group was 1.54 and 2.10 in the trolamine group (p = 0.03). Self-assessed satisfaction was greater with calendula. Prevention of erythema was 69% in the calendula arm versus 39% in the trolamine arm. Prevention of pain was 65% with calendula versus 46% with trolamine. Calendula was considered more difficult to apply as noted by 30% of the calendula group versus 5% of trolamine group. The risk of skin toxicity of grade 2 or higher was significantly increased for women whose body mass index was 25 or higher (p < 0.001), who had received chemotherapy before radiation therapy after a lumpectomy (p = 0.01), and who were using trolamine (p < 0.001).

Conclusions:

Calendula was shown to be effective in reducing skin toxicity of radiation compared to trolamine.

Limitations:

Because of differences in texture, color, and smell, it was not possible to perform a double-blind randomized study.

Sharp, L., Finnilä, K., Johansson, H., Abrahamsson, M., Hatschek, T., & Bergenmar, M. (2013). No differences between Calendula cream and aqueous cream in the prevention of acute radiation skin reactions – Results from a randomised blinded trial. European Journal of Oncology Nursing, 17, 429–435. 

doi: 10.1016/j.ejon.2012.11.003
Print

Study Purpose:

To compare two topical agents (Calendula Weleda® cream and Essex® cream) in reducing the risk of severe acute radiation skin reactions in women receiving adjuvant radiation therapy for breast cancer

Intervention Characteristics/Basic Study Process:

Patients randomly were assigned one of two creams (Calendula or Essex) and applied a thin layer twice daily from the beginning of radiotherapy through two weeks after their final radiation treatment or until the skin reaction healed. The cream was not applied within two hours of the radiation treatment. Patients were advised to wash daily with nonperfumed soap and told not to apply other topicals in the radiation field. Patients completed questionnaires related to quality of life (European Organization for Research and Treatment of Cancer [EORTC]-QLQ C30), sleep (MOS), and symptoms (e.g., pain, tenderness, burning, pulling, itching) related to the radiation field on a visual analog scale.

Sample Characteristics:

  • N = 411    
  • MEAN AGE = 58 years
  • MALES: 0%, FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Women with breast cancer who had previous partial or modified radical mastectomy and were to undergo adjuvant external beam radiation therapy
  • OTHER KEY SAMPLE CHARACTERISTICS: Treatment fractions were 2Gy per day, five days per week, up to 50Gy total dose, or 2.66Gy per day, five days per week, up to a total dose of 42.56Gy. All patients younger than 40 years had a boost of 16Gy in 2Gy per fraction. Treatment was photons 6MV or in combination with 15MV or 18MV.

Setting:

  • SITE: Single institution  
  • SETTING TYPE: Radiation unit  
  • LOCATION: Department of Oncology at Karolinska University Hospital

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Adults 

Study Design:

  • Two arm, blinded, randomized phase III trial

Measurement Instruments/Methods:

  • Primary endpoint statistics: Fisher’s exact test
  • Secondary endpoint: Linear regression
  • The primary endpoint of this study was the difference in the proportion of patients with severe acute radiation skin reactions using the Radiation Therapy Oncology Group (RTOG)/EORTC scale for radiation morbidity scoring criteria.
  • Patients were evaluated by radiation therapy nurses who had received education on the use of the RTOG/EORTC scale in the form of 90-minute workshops and lectures.
  • Assessment took place on three occasions: the first day of radiation treatment, the last day of treatment, and at a follow-up visit 5–17 days after the final radiation treatment.
  • The secondary endpoint of this study was patient-reported outcomes (using quality of life and sleep questionnaires and symptom ratings on a visual analog scale).

Results:

Researchers found no statistically significant difference in severe acute radiation skin reactions in the group using Calendula cream versus the group using Essex cream (a water-based topical emollient, which is the standard of care in that institution.) Severe acute radiation skin reaction (RTOG/EORTC grade less than or equal to 2) was 23% in the Calendula group versus 19% in the Essex group. There were no differences in patient-reported outcomes in terms of pain, burning, itching, pulling, or tenderness at the radiation site. However, there was a statistically significant difference in patient evaluation of application and absorption of the cream in favor of Essex cream.

Conclusions:

There was no difference in severe acute radiation skin reactions in women with breast cancer using Calendula cream or Essex cream during radiation therapy.

Limitations:

  • Key sample group differences that could influence results
  • Other limitations/explanation: The timing of the follow-up visit was variable at a length of 5–17 days post-radiation therapy. Treated skin heals over time, and a more acute skin reaction is likely at five days post-treatment versus two weeks or longer off treatment.

Nursing Implications:

Patients with breast cancer undergoing curative radiation therapy may experience a less severe acute radiation skin reaction using twice daily application of Calendula cream or an aqueous-based cream. Future studies could include patients with other types of cancer and different treatment fields to compare benefits of these topical emollients.


Menu