Study characteristics |
Population characteristics |
Intervention characteristics |
Outcome characteristics |
Year, Country |
Objective |
Total n Irradiated Area |
Age Mean (years) |
Intervention (n) |
Control (n) |
Follow-Up (months) |
Primary outcomes |
RD* Criteria |
Main Results |
2012(2222 Abbas H, Bensadoun RJ. Trolamine emulsion for the prevention of radiation dermatitis in patients with squamous cell carcinoma of the head and neck. Support Care Cancer. 2012;20(1):185-90. doi: http://dx.doi.org/10.1007/s00520-011-1110-3
http://dx.doi.org/10.1007/s00520-011-111...
) Egypt |
To compare trolamine with usual care for patients with head and neck cancer undergoing radiotherapy with concurrent chemotherapy |
30 Head and neck |
54.5 |
Trolamine emulsion (15) |
Usual care (15) |
16 |
Development of mild reaction (grades 1 and 2), and higher-grade RD* |
RTOG† Acute Radiation Toxicity Criteria |
Grade 1-2 TA‡: 80% (12/15) CA§: 46.6% (7/15) P< 0.01 Grade 3 TA‡: 20% (3) CA§: 53.4% (8) P<0.01 Grade 4: none |
2006(1919 Elliott EA, Wright JR, Swann RS, Nguyen-Tân F, Takita C, Bucci MK, et al. Phase III Trial of an emulsion containing trolamine for the prevention of radiation dermatitis in patients with advanced squamous cell carcinoma of the head and neck: results of Radiation Therapy Oncology Group Trial 99-13. J Clin Oncol. 2006;24(13):2092-7. doi: http://dx.doi.org/10.1200/JCO.2005.04.9148
http://dx.doi.org/10.1200/JCO.2005.04.91...
) Canada |
To compare trolamine emulsion, as a prophylactic agent and as an interventional agent, with declared institutional preference in reducing the incidence of higher-grade RD* |
494 Head and neck |
59.0 |
Trolamine emulsion Prevention (163) Treatment (172) |
Institutional preference (159) |
19 |
Reduction of grade 2 or higher RD* |
NCI/CTC|| version 2.0 ONS¶ - toxicity scoring system |
Grade 0** TA‡: 3% (5/163) CA§: 1% (2/159) Grade 1 TA‡: 18% (30/163) CA§: 20% (31/159) Grade 2 TA‡: 54% (88/163) CA§: 57% (90/159) Grade 3 TA‡: 21% (35/163) CA§: 20% (31/159) Grade 4 TA‡: 3% (5/163) CA§: 3% (5/159) P = 0.82 |
2001(1717 Fenig E, Brenner B, Katz A. Topical Biafine and Lipiderm for the prevention of radiation dermatitis: a randomized prospective trial. Oncol Rep. 2001;8(2):305-9. doi. http://dx.doi.org/10.3892/or.8.2.305
http://dx.doi.org/10.3892/or.8.2.305...
) Israel |
To evaluate the effectiveness of Biafine and Lipiderm in preventing RD* |
75 Breast |
69 |
Biafine (25) |
Lipiderm (24) Control (25) |
- |
Incidence of RD* |
RTOG†
|
Grade 3-4 reaction†† TA‡: 25% (6/25) Lipiderm: 23% (5/24) Control: 25% (6/25) P = 0.98 |
2000(1616 Fisher J, Scott C, Stevens R, Marconi B, Champion L, Freedman GM, et al. Randomized phase III study comparing best supportive care to biafine as a prophylactic agent for radiation-induced skin toxicity for women undergoing breast irradiation: Radiation therapy oncology group (RTOG) 97-13. Int J Radiat Oncol Biol Phys. 2000;48(5):1307-10. doi. http://dx.doi.org/10.1016/S0360-3016(00)00782-3
http://dx.doi.org/10.1016/S0360-3016(00)...
) United States of America |
To compare Biafine to best supportive care in preventing RD* |
140 Breast |
61 |
Trolamine (66) |
Best supportive care (74) |
4 |
Prevention or reduction of RD* - Time to develop grade 2 or high skin toxicity |
RTOG†
|
Grade 0 TA‡: 9% (6/66) CA§: 7% (5/74) Grade 1 TA‡: 50% (33/66) CA§: 58% (43/74) Grade 2 TA‡: 41% (27/66) CA§: 32% (24/74) Grade 3 TA‡: 0% (0/66) CA§: 3% (2/74) |
2010(2121 Gosselin TK, Schneider SM, Plambeck MA, Rowe K. A Prospective Randomized, Placebo-Controlled Skin Care Study in Women Diagnosed With Breast Cancer Undergoing Radiation Therapy. Oncol Nurs Forum. 2010;37(5):619-26. doi: http://dx.doi.org/10.1188/10.ONF.619-626
http://dx.doi.org/10.1188/10.ONF.619-626...
) United States of America |
To evaluate three commonly used skin care products for women receiving whole-breast radiotherapy against a placebo |
208 Breast |
Placebo 55.8 Aquaphor® 54.8 Biafine® RE 56 RadiaCare™ 55.6 |
Trolamine (Biafine® ) (53) |
Placebo (49) Aquaphor® (53) RadiaCare™ (53) |
48 |
Prevention or reduction of RD* |
RTOG†
|
Grade 2 to 4‡‡ TA‡: 90% (47.7/53) Placebo: 80% (39.2/49) Aquaphor®: 80% (42.4/53) RadiaCare™ 72% (38.16/53) |
2004(1818 Pommier P, Gomez F, Sunyach MP, D’Hombres A, Carrie C, Montbarbon X. Phase III randomized trial of Calendula officinalis compared with trolamine for the prevention of acute dermatitis during irradiation for breast cancer. J Clin Oncol. 2004;22(8):1447-53. doi: http://dx.doi.org/10.1200/JCO.2004.07.063
http://dx.doi.org/10.1200/JCO.2004.07.06...
) France |
To assess the effectiveness of calendula for the prevention of acute RD* of grade 2 or higher during postoperative radiotherapy for breast cancer, compared with trolamine |
254 Breast |
Calendula 56.5 Trolamine 55.1 |
Trolamine (128) |
Calendula (126) |
20 |
Occurrence of acute RD* of grade 2 or higher |
RTOG†
|
Grade 2 to 3 TA‡: 63% (95% CI§§, 59 to 68) CA§: 41% (95% CI§§, 37 to 46) P < 0.001 Grade 4: none |
2008(2020 Ribet V, Salas S, Levecq JM, Bastit L, Alfonsi M, De Rauglaudre G, et al. Interest of a sterilised anti-burning gel in radiation dermatitis: results of a comparative study. Ann Dermatol Vénéréol. 2008;1:5-10. doi: http://dx.doi.org/10.1016/S0151-9638(08)70091-7.
http://dx.doi.org/10.1016/S0151-9638(08)...
) France |
To evaluate the efficacy and tolerance Avène Thermal Spring Water anti burning gel versus trolamine cream in the prevention of RD* |
69 Head and neck Breast |
57.9 |
Trolamine cream (34) |
Avène Thermal Spring Water anti burning gel (35) |
- |
Time to onset of the first signs of RD* |
National Cancer Institute |
Grade 0 TA‡: 24.1% (7/29) CA§: 23.3% (7/30) Grade 1 TA‡: 34.5% (10/29) CA§: 46.7% (14/30) Grade 2 TA‡: 34.5% (10/29) CA§: 26.7% (8/30) P = 0.347 |