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

Elliott, Elizabeth; Wright, James R.; Swann, Ruth; Nguyen-Tan, F.; Takita, Cristiane; Bucci, M. Kara; Garden, Adam S.; Kim, Harold; Hug, Eugen B.; Ryu, Janice; Greenberg, Michael J.; Saxton, Jerrold P.; Ang, K. Kian; Berk, Lawrence

doi:10.1200/jco.2005.04.9148

Cited by 103 publications

(95 citation statements)

References 16 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Skin reactions were often assessed by one evaluator, which was commonly a radiation oncologist, dermatologist, research nurse, research assistant, radiation therapist, principal investigator, or other medical professional 3,17,20,21,24,26,27,32,33,35,39,44,46,50 . A few studies incorporated an inter-rater reliability measure by having more than one evaluator assess the skin reactions 23,34,36,45,49,51 ; the remaining studies did not describe who assessed the radiated area or areas 2,16,19,25,28,30,31,38,[41][42][43]47,48 .…”

Section: Resultsmentioning

confidence: 99%

“…The second most common tool in use was the U.S. National Cancer Institute's Common Toxicity Criteria (nci ctc), which is similar to the rtog and was used in nine studies 2,3,26,28,30,[37][38][39]46 . The remaining studies used a study-designed tool closely modeled after either the rtog or nci tool, with slight variations [18][19][20]23,31,43,49 .…”

Section: Resultsmentioning

confidence: 99%

“…Best supportive care was defined as "institutional preference" and included Aquaphor Healing Ointment (Beiersdorf Canada, St. Laurent, QC) and Aloe vera as the top two choices. In a similar large multicentre study, Elliot et al 28 evaluated Biafine cream in the preventive and interventional settings against an institutional preference, which was different for each centre. Both trials reported no significant difference between Biafine cream and institutional preference for the prevention of radiation-induced skin reactions 24,28 .…”

Section: Nonsteroidal Topical Creamsmentioning

confidence: 99%

“…Five of those trials compared Biafine with another topical agent 24,25,[27][28][29] , and one evaluated the efficacy of Biafine cream without a comparator product 26 .…”

Section: Nonsteroidal Topical Creamsmentioning

confidence: 99%

“…Biafine Cream: Six studies assessed Biafine cream (Ortho-McNeil Pharmaceuticals, Titusville, NJ, U.S.A.) for the prevention of radiation-induced skin reactions [24][25][26][27][28][29] . Five of those trials compared Biafine with another topical agent 24,25,[27][28][29] , and one evaluated the efficacy of Biafine cream without a comparator product 26 .…”

Section: Nonsteroidal Topical Creamsmentioning

confidence: 99%

See 4 more Smart Citations

Prophylaxis and Management of Acute Radiation-Induced Skin Reactions: A Systematic Review of the Literature

et al. 2010

View full text Add to dashboard Cite

Radiation therapy is a common treatment for cancer patients. One of the most common side effects of radiation is acute skin reaction (radiation dermatitis) that ranges from a mild rash to severe ulceration. Approximately 85% of patients treated with radiation therapy will experience a moderate-to-severe skin reaction. Acute radiation-induced skin reactions often lead to itching and pain, delays in treatment, and diminished aesthetic appearance-and subsequently to a decrease in quality of life.Surveys have demonstrated that a wide variety of topical, oral, and intravenous agents are used to prevent or to treat radiation-induced skin reactions. We conducted a literature review to identify trials that investigated products for the prophylaxis and management of acute radiation dermatitis. Thirty-nine studies met the pre-defined criteria, with thirty-three being categorized as prophylactic trials and six as management trials.For objective evaluation of skin reactions, the Radiation Therapy Oncology Group criteria and the U.S. National Cancer Institute Common Toxicity Criteria were the most commonly used tools (65% of the studies). Topical corticosteroid agents were found to significantly reduce the severity of skin reactions; however, the trials of corticosteroids evaluated various agents, and no clear indication about a preferred corticosteroid has emerged. Amifostine and oral enzymes were somewhat effective in preventing radiation-induced skin reactions in phase ii and phase iii trials respectively; further large randomized controlled trials should be undertaken to better investigate those products. Biafine cream (Ortho-McNeil Pharmaceuticals, Titusville, NJ, U.S.A.) was found not to be superior to standard regimes in the prevention of radiation-induced skin reactions (n = 6).In conclusion, the evidence is insufficient to support the use of a particular agent for the prevention and management of acute radiation-induced skin reactions. Future trials should focus on comparing agents and approaches that, in phase i and ii trials, suggest efficacy. These future phase iii randomized controlled trials must clearly distinguish between preventive and management strategies for radiation-induced dermatitis. Only then can evidence-based guidelines be developed, with the hope of standardizing the approach across centres and of improving the prevention and management of radiation-induced dermatitis.

show abstract

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Nonsteroidal Topical Creamsmentioning

confidence: 99%

“…Five of those trials compared Biafine with another topical agent 24,25,[27][28][29] , and one evaluated the efficacy of Biafine cream without a comparator product 26 .…”

Section: Nonsteroidal Topical Creamsmentioning

confidence: 99%

Section: Nonsteroidal Topical Creamsmentioning

confidence: 99%

See 3 more Smart Citations

Prophylaxis and Management of Acute Radiation-Induced Skin Reactions: A Systematic Review of the Literature

et al. 2010

View full text Add to dashboard Cite

show abstract

Radiation‐Induced Skin Reactions

Wong

Kassam

2013

Dermatologic Principles and Practice in Oncology

View full text Add to dashboard Cite

Chinese clinical practice guidelines for the prevention and treatment of radiation‐induced dermatitis

Fan,

Feng,

Yuan

2023

Precision Radiation Oncology

View full text Add to dashboard Cite

Radiation‐induced dermatitis is one of the most prevalent complications in patients undergoing cancer radiotherapy and poses a significant challenge to cancer therapy. The symptoms include erythema, dry desquamation, and moist desquamation, which are frequently observed in patients with breast, head and neck, anal, and vulvar cancers. Early skin reactions typically manifest within 2–4 weeks following the initiation of radiotherapy. In severe cases, acute dermatitis can cause radiotherapy interruptions, prolong treatment time, and ultimately affect patient outcomes and quality of life. Currently, there are numerous guidelines on radiation dermatitis, including the Multinational Association of Supportive Care in Cancer (MASCC), British Columbia Cancer Agency (BCCA), Oncology Nursing Society (ONS), and UK Society of Radiographers (SCoR) guidelines. In China, dermatology experts have drafted a consensus. However, due to the differing backgrounds of experts, recommendations among guidelines vary. These guidelines were first developed by Chinese radiation oncologists. The evidence‐based guideline in this paper fully considers and adopts China's national conditions; hence, it can be easily applied in daily practice.

show abstract

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

Cited by 103 publications

References 16 publications

Prophylaxis and Management of Acute Radiation-Induced Skin Reactions: A Systematic Review of the Literature

Prophylaxis and Management of Acute Radiation-Induced Skin Reactions: A Systematic Review of the Literature

Radiation‐Induced Skin Reactions

Chinese clinical practice guidelines for the prevention and treatment of radiation‐induced dermatitis

Contact Info

Product

Resources

About