Meta AnalysisID 374
金盏花及其对癌症患者放射性皮炎预防与治疗的效果：系统评价与Meta分析
CRD42021278737
1. What is the effect of Calendula topical applications on the prevention or treatment of acute radiation dermatitis (ARD) in cancer patients undergoing radiotherapy? 2. What is the effect of Calendula topical applicatio
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Record Fields
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- Meta Analysis Id
- 374
- Evidence Id
- 8932
- Core Evidence Id
- 8932
- Source Meta Analysis Id
- 354
- Herb2 Meta Analysis Id
- HBMA000354
- Crd Id
- CRD42021278737
- Title
- Calendula and its effect on Radiation Dermatitis Prevention and Treatment among Cancer Patients: A Systematic Review and Meta-Analysis
- Review Question
- 1. What is the effect of Calendula topical applications on the prevention or treatment of acute radiation dermatitis (ARD) in cancer patients undergoing radiotherapy? 2. What is the effect of Calendula topical application on the patient’s reported outcomes relating to acute radiodermatitis, including pain, itching, and quality of life? 1.3. What is the compliance to Calendula topical application (dropout rate and any adverse effects)?
- Study Type Included
- Randomized Control Trials (regardless of blinding) will only be included in this review.
- Condition Being Studied
- The primary domain of the study is acute radiation dermatitis (ARD), which is one of the most common side effects of radiotherapy occurring in about 95% of cancer patients receiving radiotherapy. The severity of this condition varies: from erythema to moist desquamation, a more severe reaction concerning the degradation of the epithelial barrier, which causes skin thinning, pigmentation, and pain. Radiation dermatitis can impair daily functioning for a patient and one may stop receiving RT because of ARD-related symptoms, which may furthermore be harmful to patients in the long term. Clinical Assessment tools, such as RTOG, CTCAE, ONS, and RDS, are used to evaluate ARD during, at the end of treatment, or within 1-2 months after the intervention.
- Participant
- The study population will be adult cancer patients. Inclusion criteria will include: 1) adults (age ≥ 18 years), 2) having a history of cancer (any stage), 3) plan to receive radiation treatment for the purpose of cancer treatment.
- Animal
- Human Disease Modelled
- Intervention
- The intervention of interest is the use of topical Calendula, an ingredient often included in non-steroidal herbal creams, for the purpose of prevention or treatment of radiation dermatitis. Calendula creams are extracted from the marigold flower of the Compositae family (Calendula Officinalis). The active ingredients are triterpenoid monoesters, terpene alcohols, carotenoids, which furthermore have antioxidant and anti-inflammatory properties. Thus, any formulation or carrier with Calendula as the main ingredient will be included.
- Comparator Control
- The control group can include no intervention, placebo, or other forms of skin care (including moisturizing creams, skin dressings, topical steroidal creams, and standard skin care).
- Main Outcome
- The main outcome will be acute radiodermatitis, measured via clinical assessment tools such as RTOG, CTCAE, ONS, and RDS by clinicians (not by patients). No restriction of clinical assessment tool will be made and will be reported as stated in articles (average ARD score/grade, % incidence of grade1/2/3/4 or moist-desquamation between two groups). Measures of effect Relative risk (RR)of occurrence of grade 2+/3+/moist-desquamation comparing those in the intervention group vs. control group and its 95% confidence intervals (CIs). For the average scores, standardized mean difference (and the standard deviation) will be used to compare the two groups. Whether the results were from intention-to-treat analysis or protocol-based analysis will be recorded. If both results were reported, the result from the intention-to-treat analysis will be included in the meta-analysis.
- Outcome Measure
- Additional Outcome
- 1. Other patient-reported QOL outcomes relating to ARD (pain, redness, itching, or overall QOL score) 2. Compliance with the intervention (adverse effects, side effects, drop-out rate) Measures of effect For the continuous variables, the mean score and SD for each group will be collected and the standardized mean difference will be evaluated. For the categorical variables, % occurrence will be collected and RR will be evaluated
- Study Method
- Intervention, Meta-analysis, Prevention, Systematic review
- Keyword
- Calendula; Humans; Neoplasms; Radiodermatitis
- Contact
- Eunkyung Lee [email protected]
- Organisational Affiliation
- University of Central Florida
- Funding Source
- None Grant number(s) <span style=font-size: 14px>State the funder, grant or award number and the date of award</span> None
- Other Selection Criteria
- Final Publication
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- United States of America
- Review Stage
- Review Ongoing
- First Submission Date
- 2021-09-23
- Registration Date
- 2021-10-24
- Anticipated Start Date
- 2021-09-06
- Anticipated Completion Date
- 2021-12-31
- Title Cn
- 金盏花及其对癌症患者放射性皮炎预防与治疗的效果：系统评价与Meta分析
- Title En
- Calendula and its effect on Radiation Dermatitis Prevention and Treatment among Cancer Patients: A Systematic Review and Meta-Analysis
- Bilingual Status
- complete