Olsen et al. (2001): The effect of aloe vera gel/mild soap versus mild soap alone in preventing skin reactions in patients undergoing radiation therapy

Reference ↗
Title	The effect of aloe vera gel/mild soap versus mild soap alone in preventing skin reactions in patients undergoing radiation therapy
Topic	Aloe vera
Author	Olsen, DL, Raub, W Jr, Bradley, C, Johnson, M, Macias, JL, Love, V, Markoe, A
Year	2001
Journal	Oncology Nursing Forum
DOI	https://pubmed.ncbi.nlm.nih.gov/11338761/

Brief summary

In this study, researchers investigated the effect of an aloe vera gel (100%) on skin reactions in patients undergoing radiotherapy. During radiotherapy patients were given a mild, unscented soap, with which to cleanse their skin. About half of the patients also received the aloe gel, which they applied directly to their radiated skin every day after radiotherapy. The researchers found, that patients of the aloe arm tended to have less erythema, but only when the radiation dose was above 2,700. Patients of the aloe arm also took longer for their skin to react to the radiation, but again only when the radiation dose was above 2,700.

In dieser Studie untersuchten Forscher die Wirkung eines Aloe Vera Gels (100%) auf Hautreaktionen bei Patienten, die eine Strahlentherapie erhalten sollen. Während der Strahlentherapie erhielten die Patienten eine milde, unparfümierte Seife, mit der sie ihre Haut reinigen konnten. Etwa die Hälfte der Patienten erhielt zusätzlich das Aloe-Gel, das sie jeden Tag nach der Bestrahlung direkt auf ihre bestrahlte Haut auftrugen. Die Forscher fanden, dass Patienten, die das Aloe-Gel verwendeten, tendenziell seltener Erytheme hatten, aber nur, wenn die Strahlendosis über 2.700 lag. Bei Patienten, die das Aloe-Gel verwenden, dauerte es auch länger, bis ihre Haut auf die Strahlung reagierte, aber wieder nur, wenn die Strahlendosis über 2.700 lag.

Study Design

Prospective / Retrospective Prospective: forward-looking, examples include clinical trials, cohort studies, and long-term observational studies;</br>Retrospective: backward-looking, relying on existing data, examples include case-control studies and retrospective cohort studies	Prospective
Monocentric / Multicentric Monocentric: conducted in one center/ hospital; </br>Multicentric: conducted in multiple centers/ hospitals	Monocentric
Blinding No: Open, all parties are aware of group assignments;</br>Single: one party is unaware of group assignments (generally participants);</br>Double: two parties are unaware of group assignments (generally the participants and the researchers); </br>Triple: concealing group assignment from additional parties	Double
Is randomized	Yes
Cross-over Participants alternate between different treatment groups or conditions over a specified period, allowing each participant to serve as their own control	No
Number of arms	2

Study characteristics

Inclusion criteria	Cancer patients undergoing radiotherapy
Exclusion criteria	Radiotherapy of the brain or for gynaecological cancers
N randomized	73
Analysis PP: Per Protocol analysis, i.e. only participants included who adhered to the study protocol.</br>ITT: Intention-to-treat analysis, i.e. all randomized participants included regardless of any drop-outs or changes in assignment.</br>mITT: modified Intention-to-treat analysis can refer to analyses in which participants with missing outcome data are excluded or it can refer to analyses in which only participants who received at least one treatment dose are included. In this case, participants dropped out of the study prematurely for reasons unrelated to the treatment.	PP Analysis
Specifications on analyses	Data of 70 patients were availible.
Countries of data collection	United States
LoE Level of evidence	2b Oxford 2009
Outcome timeline Data collection times	T0: Baseline proir to first radiation T1: weekly until the end of radiation

Characteristics of participants

Setting Refers to cancer therapy setting.</br>- Curative therapy: aims to completely eradicate a disease and achieve a full recovery; </br>- Neo-adjuvant therapy: form of curative therapy, given before the primary treatment for cancer (usually surgery); </br>- Adjuvant therapy: form of curative therapy, given after the primary treatment for cancer (usually surgery); </br>- Palliative therapy: focuses on providing relief from symptoms and improving the quality of life for patients, without necessarily targeting the underlying disease; </br>- Active surveillance: involves close monitoring of disease progression without any intervention (typically used for prostate cancer);</br>- No therapy setting: Patients who completed therapy/are currently not in cancer treatment, cancer survivors.	Curative
Types of cancer "Other Cancers" means that only a subpopulation was specified, but further unspecified cancer types were included	Head and Neck Cancers, Breast Cancer, Gastrointestinal Cancers, Prostate Cancer
Cancer stages Early Stage: generally refers to cancer that is localized to the area where it started, mostly stages I and II;</br>Advanced Stage: cancer that has spread beyond its original site, mostly stages III and IV, with stage IV indicating distant metastasis	NI
Specifications on cancer stages	Tumor site: Head/neck: Aloe arm = 39%; Control arm = 43% Chest: Aloe arm = 58%; Control arm = 52% Abdomen/pelvis: Aloe arm = 0%; Control arm = 3% Extremities: Aloe arm = 3%; Control arm = 2%
Comorbidities	NI
Current cancer therapies	Radiation therapy
Specifications on cancer therapies	Chemotherapy: Aloe arm: Yes = 28%, No = 72% Control arm: Yes = 26%, No = 74% Cumulative dose was dichotomized into ≤2,700 cGy or >2,700 cGy.
Previous cancer therapies	Chemotherapy
Gender	Mixed
Gender specifications	Gender of the participants: female = 48 (66%); male = 25 (34%)
Age groups	Adults (18+)
Age groups specification	Mean age of the participants = 56 years (Range: 18-84) Aloe arm: <45 years = 18%; 45-59 years = 55%; >60 years = 27% Control arm: <45 years = 18%; 45-59 years = 32%; >60 years = 50%

Arms

Arm type Active control: group receives active treatment; </br>Passive control: for example treatment as usual, waiting control, no treatment	Intervention
Number of participants (arm) N randomized	32
Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date	Not arm specified: 3
Drop-out reasons	1 = did not receive insurance authorization 1 = decision to delay radiotherapy until chemotherapy administration was completed 1 = refused radiation therapy
Intervention	Aloe vera
Dosage and regime	Apply the 100% aloe vera gel to the irradiated skin up 6 to 8 times a day after radiotherapy from the start of radiotherapy until the end of therpy + all patients: advised to gently clean the irradiated skin with mild, unscented soap and dry it with a soft, clean towel, protect the skin from injury, avoid prolonged exposure to sunlight and wear loose-fitting clothing.
One-time application	No
Duration in days For long-term interventions, the number of days is an estimation.</br>A value of -999 indicates that the exact duration cannot be extracted from the study due to ambiguous or incomplete information. See Outcome timeline or Dosage and regime for further information.	56
Side effects / Interactions	Not reported, although no allergic skin reactions to aloe have been documented.

Arm type Active control: group receives active treatment; </br>Passive control: for example treatment as usual, waiting control, no treatment	Passive control
Number of participants (arm) N randomized	38
Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date	Not arm specified: 3
Drop-out reasons	1 = did not receive insurance authorization 1 = decision to delay radiotherapy until chemotherapy administration was completed 1 = refused radiation therapy
Intervention	No additional intervention
Dosage and regime	+ all patients: advised to gently clean the irradiated skin with mild, unscented soap and dry it with a soft, clean towel, protect the skin from injury, avoid prolonged exposure to sunlight and wear loose-fitting clothing.
One-time application	No
Duration in days For long-term interventions, the number of days is an estimation.</br>A value of -999 indicates that the exact duration cannot be extracted from the study due to ambiguous or incomplete information. See Outcome timeline or Dosage and regime for further information.	56
Side effects / Interactions	NA

Outcomes

Toxicity

Outcome type As specificed by the authors	Primary
Outcome specification	Nurses and physicians cunducted the skin weekly. Morbidity score: 0 = No change 1 = Faint/dull erythema 2 = Bright erythema 3 = Moist desquamation 4 = Ulceration/necrosis
Type of measurement	RTOG Acute Radiation Morbidity Scoring Criteria (Radiation Therapy Oncology Group)
Results during intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".	Erythema/itching/skin appearance/discolouration: No differences between the arms. Time to skin changes due to cumulative radiation dose: ≤2,700cGy: No differences between the arms. >2,700cGy: Significantly longer time in the Aloe arm (median 5 weeks) until the appearance of skin changes compared to control arm (median 3 weeks), p=0.013.
Results after intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".	NA

Risk of Bias Assessment: Cochrane RoB tool 2.0
Bias arising from the randomization process	?
Bias due to deviation from intended intervention (assignment to intervention)	?
Bias due to deviation from intended intervention (adhering to intervention)	NA
Bias due to missing outcome data	?
Bias in measurement of the outcome	?
Bias in selection of the reported result	?
Other sources of bias	?
Overall RoB judgment	?

Funding and Conflicts of Interest

Funding	NI
Conflicts of Interest	NI

Further points for assessing the study

Sample

Power analysis performed	?
- Sample size corresponds to power analysis	?
- Reasons for insufficient sample size based on power analysis	?
If no power analysis performed: at least moderate sample size (n >= 30 per arm)	?
Ethnicity mentioned	?

Alternative Explanation

Other explanations for an effect besides the investigated intervention	?
- Possibility of attention effects	?
- Possibility of placebo effects	?
- Other reasons	?

Statistics

Correct use of parametric and non-parametric tests Testing for normal distribution only necessary if parametric tests are used, NI: use of parametric tests without report of normal distribution testing	?
Correction for multiple testing	?
Measurement of compliance	?
Consistent reporting in numbers (figures, flowchart, abstract, results)	?
Comprehensive and coherent reporting	?
Cross-over	?
- Sufficient washout period	?
- Tested for carry-over effects	?
- Tested for sequence effects	?

Interpretation of results

Effect sizes reported (clinical vs. statistical significance)	?
Side effects systematically recorded	?
Side effects considered in result interpretation	?
Ethics votum	?

Additional Notes

PRO/CONTRA