8795

Study Purpose

To explore the anti-inflammatory and radiodermatitis prevention efficacy and safety of a Boswellia-based topical cream among patients with breast cancer

Intervention Characteristics/Basic Study Process

Placebo arm: Base cream

Experimental arm: 2% Boswellia serrata cream in Phytosome (R) (Bosexil [R])

The assigned cream was applied after radiotherapy and before bedtime on the days of treatment and in the morning and at night on nontreatment days.

Sample Characteristics

N = 114
MEAN AGE = 58.5 years (32–78)
MALES (%): Not stated, FEMALES (%): Not stated
KEY DISEASE CHARACTERISTICS: Breast carcinoma
OTHER KEY SAMPLE CHARACTERISTICS: All participants were overweight.

Setting

SITE: Not stated/unknown
SETTING TYPE: Not specified
LOCATION: Not stated; however, the researchers were from Italy.

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Parallel-group
Randomized
Placebo-controlled

Measurement Instruments/Methods

Visual grading scale consisting of “slight (slight redness, spotty, and diffuse), moderate (moderate and uniform redness), [and] intense (intense redness)” (Togni et al., 2015, p. 1340)
Radiation Therapy Oncology Group (RTOG) acute skin toxicity
Photographs taken of nonirradiated and irradiated breast areas using an SLR camera without flash in ambient office exam room light, computer-assisted analysis using Adobe Photoshop CS2 with image reader, and digital evaluation of magenta color saturation in percent
Use of a steroid cream in addition to the study cream

Results

Significantly more visually intense erythema existed in the placebo group compared to the Boswellia group in general (p = 0.009) and when no concurrent chemotherapy was used (p = 0.018). However, no statistically significant difference existed when concurrent chemotherapy was used (p = 0.258). A highly significant decrease was observed in the use of supplemental steroid cream in the Boswellia group (25%) compared to the placebo group (63%, p < 0.0001). More participants in the Boswellia group had grade 1 RTOG scores, and more participants in the placebo cream group had grade 2 scores. However, the difference was not significance (p = 0.066). No significant differences in adverse effects existed between groups.

Conclusions

Further studies are needed to compare Boswellia serrata with other topical products among patients with breast cancer undergoing radiotherapy.

Limitations

The process of randomization was not well described. The first two authors are employed by and fourth author is a consultant for a company that develops botanical pharmaceuticals. Patient use of both a topical steroid cream with Boswellia serrate cream may prohibit the full pharmacologic outcome of using just one topical cream.

Nursing Implications

Boswellia serrata may be useful in reducing breast radiodermatitis. However, additional larger and independent studies are needed.