# Radiation Oncology/Skin care

* Front Page: Radiation Oncology | RTOG Trials | Randomized Trials

## Gels/Creams

* ALOCANE Plus - Physician Dispensed Only. Active ingredients Lidocaine HCL 4% and Benzalkonium Chloride 0.13%. (Topical Anesthetic/Anti-Microbial Gel used for Radiation Dermatitis. Packaged in 3.5mL single dose foil packs and 50 count pro-packs). Manufacturer: Quest Products
* Alra Therapy Lotion. Non-Rx; comes in 4 oz. bottle; used in hospitals over 15 years [needs citation]. Manufacturer: Alra.com
* Remedy Skin Repair Cream Remedy Advanced Skin Care
* Elta creme Website
* Glucan Professional Moisturizing Cream - comes in a tube, does not erase skin marks. Manufacturer: Brennen Medical
* Glucan Pro 3000 - comes in a jar, acts as a better barrier but erases skin marks. Manufacturer: Brennen Medical
* Silvadene cream
* Herb to Soothe™ Botanical Cream. Herbal remedy delivers multi-target approach to healing skin. Manufacturer: Unitech Medical
* Udder cream
* AloePlex Gel. Non-Rx. (Apply to involved skin TID. Supplied as: 3 oz tubes. One month supply = 3-6 tubes). Manufacturer: MPM Medical
* RadiaPlex Gel. (Apply to involved skin TID. Supplied as: 3 oz tubes. One month supply = 3-6 tubes). Manufacturer: MPM Medical
* Biafine. Rx. Active ingredient trolamine. (Use TID for radiation dermatitis. supplied as 45g and 90g tubes). Website
** Studies: See RTOG 99-13 (H&N, PMID 16648511 ), RTOG 97-13 (Breast, PMID 11121627), PMID 11516855 (Phase II, breast)
* Aquaphor. Eucerin website
* Xclair. Includes hyaluronic acid. Xclair website
* Miaderm Radiation Relief. Includes Calendula, hyaluronic acid, and aloe vera. Manufacturer: Miaderm.com

## Barriers

* Remedy Nutrashield Remedy Advanced Skin Care
* Remedy Calazime Protectant Paste Remedy Advanced Skin Care
* Remedy Dimethicone Mositure Barrier Remedy Advanced Skin Care
* Remedy Clear Aid Remedy Advanced Skin Care
* Vigilon
* OraMagic Patch (see under Head and Neck care)
* CoolMagic Gel Sheet. Provides a soothing, cooling effect. (Supplied as: 3.75"x3.75", 6"x8", 8"x12". 10 per box.) Manufacturer: MPM Medical

## Skin Fibrosis

* Montpellier; 2008 (France) PMID 18211604 -- "A randomized, prospective study using the LPG((R)) technique in treating radiation-induced skin fibrosis: clinical and profilometric analysis." (Bourgeois JF, Skin Res Technol. 2008 Feb;14(1):71-6.)
** Randomized. 20 women, s/p BCS + RT 6-16 months prior. Arm 1) LPG((R)) massage vs. Arm 2) observation
** Outcome: LPG massage improved erythema, decreased pain and pruritus, decreased feeling of induration, and improved skin softness
** Conclusion: Improvement after clinical signs after LPG massage

## Acute Dermatitis

* Acute dermatitis was described as early as 1924, and was initially used to guide dosimetry
* Severe skin reactions typically happen where skin rubs together (e.g. inframammary fold, neck, groin, perineum) or where there are dosimetric hotspots. The hotspots may be deeply subcutaneous, as described by Pignol in their breast IMRT trial correspondence (PMID 18591570)
* The prevalence of moist desquamation is 30-50%, and may be as high as 60% in patients treated for nasopharyngeal cancer
* Risk factors include smoking, use of bolus, and concurrent chemotherapy
* For many decades, skin washing during RT was forbidden. Randomized evidence showed that skin washing is not harmful, and may be beneficial
* A number of randomized studies evaluated prophylactic use of creams and lotions, but none were overwhelmingly positive
* It is probably reasonable to use moisturizing creams such as Aloe Vera or Aquaphor (these were the most commonly used products in RTOG 97-13) in Grade I-II dermatitis. For Grade III-IV dermatitis, use of non-adherent absorbent dressings may be considered
* Hydrogel dressing have resulted in prolonged healing time, with no benefit for symptomatic relief, and should not be used
* For breast irradiation, axillary deodorant use is comparable in toxicity to no use, and should not be discouraged
* For cranial irradiation, routine hair washing does not influence development of skin toxicity, and probably should not be discouraged

### To Expand

* https://pubmed.ncbi.nlm.nih.gov/39608611/
* https://pubmed.ncbi.nlm.nih.gov/39560759/

### Axillary deodorant

* Quebec; 2009 PMID 19327906 -- "Use of axillary deodorant and effect on acute skin toxicity during radiotherapy for breast cancer: a prospective randomized noninferiority trial." (Theberge V, Int J Radiat Oncol Biol Phys. 2009 Nov 15;75(4):1048-52. Epub 2009 Mar 26.)
** Randomized, non-inferiority trial. 84 patients with breast RT. Arm 1) deodorant use vs. Arm 2) no deodorant.
** Outcome: Grade 2 axilla dermatitis deodorant 23% vs. no deodorant 30% (NS); Grade 2 breast dermatitis 30% vs. 34% (NS); no Grade 3+ dermatitis. Sweating deodorant 18% vs no deodorant 39% (SS)
** Conclusion: No evidence to prohibit deodorant use during breast RT

### APP cream

* St. Jude's; 2007 PMID 18093332 -- "A phase III trial comparing an anionic phospholipid-based cream and aloe vera-based gel in the prevention of radiation dermatitis in pediatric patients." (Merchant TE, Radiat Oncol. 2007 Dec 19;2:45.)
** Randomized. 45 patients, irradiated to at least 23.4 Gy (mean 34 Gy), age >3 years. Two creams applied to each patient by nursing staff, site randomly chosen prior to treatment. Arm 1) anionic polar phospholipid (APP) based cream (made by Ocular Research of Boston, Boston, MA) vs. Arm 2) aloe vera-based cream
** Outcome: Grouped scores better for APP cream. Dryness and peely skin also better for APP cream
** Conclusion: APP cream is more effective than aloe-vera based gel

### Hydrogel (moist) dressing

* Edinburgh; 2007 (UK) PMID 17363185 -- "Randomized comparison of dry dressings versus hydrogel in management of radiation-induced moist desquamation." (Macmillan MS, Int J Radiat Oncol Biol Phys. 2007 Jul 1;68(3):864-72. Epub 2007 Mar 23.)
** Randomized. 357 patients with breast (63%), H&N (30%) or anorectal CA. Arm 1) simple dry dressings vs. Arm 2) hydrogel (Intrasite). Started using from onset of moist desquammation. Prevalence of moist desquammation 28%, mean 32 days after starting treatment
** Outcome: Time-to-healing significantly worse. No impact on subjective symptoms (pain, burning, sleep). Compliance significantly better with hydrogel dressing (93% vs. 63%)
** Conclusion: Hydrogel dressing are worse than dry dressings, with prolonged healing time
* Prince of Wales; 2000 (Hong Kong) PMID 10851773 -- "The effects of hydrocolloid dressing and gentian violet on radiation-induced moist desquamation wound healing." (Mak SS, Cancer Nurs. 2000 Jun;23(3):220-9.)
** Randomized. 39 patients, 60 moist desquamation wounds. Arm 1) hydrocolloid (moist) dressing vs. Arm 2) gentian violet (control).
** Outcome: No difference between the groups; substantially worse patient satisfaction with gentian violet due to discoloration and drying
** Conclusion: No difference; patients should decide which they prefer

### XClair

* Rome; 2006 PMID 16980242 -- "A double-blind, vehicle-controlled clinical study to evaluate the efficacy of MAS065D (XClair), a hyaluronic acid-based formulation, in the management of radiation-induced dermatitis." (Primavera G, Cutan Ocul Toxicol. 2006;25(3):165-71.)
** Randomized. Patients with BCA. Arm 1) control vs. Arm 2) Xclair
** Outcome: Xclair significantly better for radiation dermatitis and erythema. No difference in pain and itch. Both patients and investigators preferred Xclair
** Conclusion: Xclair can be an effective option for managing radiation dermatitis

### Beclomethasone Spray

* Ratan Hospital; 2006 (India) PMID 17192690 -- "Prophylactic beclomethasone spray to the skin during postoperative radiotherapy of carcinoma breast: a prospective randomized study." (Shukla PN, Indian J Cancer. 2006 Oct-Dec;43(4):180-4.)
** Randomized. 60 patients with BCA treated with 50/25, randomized to beclomethasone spray to irradiated axilla vs. observation
** Wet desquammation: beclomethasone spray 13% vs. observation 37% (SS)
** Conclusion: topical steroid during RT reduces risk of wet desquammation

### Calendula

* Lyon; 2004 (France)(1999-2001) PMID 15084618 -- "Phase III randomized trial of Calendula officinalis compared with trolamine for the prevention of acute dermatitis during irradiation for breast cancer." (Pommier P, J Clin Oncol. 2004 Apr 15;22(8):1447-53.)
** Randomized. 254 patients with BCA. Arm 1) Biafine (control) vs. Arm 2) calendula.
** Outcome: Grade 2+ acute dermatitis calendula 41% vs. Biafine 63% (SS); also less frequent interruption of RT. Calendula more difficult to apply but self-assessed satisfaction greater
** Conclusion: Calendula highly effective for prevention of acute Grade 2+ dermatitis

### Theta-Cream

* Munich; 2004 (Germany)(2002) PMID 15127162 -- "Thêta-Cream versus Bepanthol lotion in breast cancer patients under radiotherapy. A new prophylactic agent in skin care?" (Roper B, Strahlenther Onkol. 2004 May;180(5):315-22.)
** Randomized. 20 patients with BCA. Arm 1) Theta-Cream vs. Arm 2) Bepanthol lotion (control). Evaluated by modified RTOG criteria and photography
** Outcome: No difference between groups. Theta-Cream trend to worse skin markings, and mild itchiness
** Conclusion: Theta-Cream not better, more expensive, and trend to worse outcome

### Nonadherent Dressings

* Prince of Wales; 2005 (Hong Kong)(2001-2003) PMID 16330964 -- "A comparison of wound treatments in nasopharyngeal cancer patients receiving radiation therapy." (Mak SS, Cancer Nurs. 2005 Nov-Dec;28(6):436-45.)
** Randomized. 146 patients with nasopharyngeal CA, who developed moist desquammation. Arm 1) nonadherent absorbent dressings vs. Arm 2) gentian violet (control). Daily cleansing with 0.9% saline. Evaluated wound healing, presence of infectin, social isolation, sleep, neck mobility
** Outcome: No difference in any outcome; trend to higher wound pain with gentian violet
** Conclusion: Nonadherent absorbent dressing can be considered for moist desquamation

### Aloe Vera

* Miami; 2001 PMID 11338761 -- "The effect of aloe vera gel/mild soap versus mild soap alone in preventing skin reactions in patients undergoing radiation therapy." (Olsen DL, Oncol Nurs Forum. 2001 Apr;28(3):543-7.)
** Randomized. Arm 1) skin clense with mild unscented soap vs. Arm 2) soap + aloe very multiple times daily.
** Outcome: No difference if dose <27 Gy; for dose >27 Gy, longer time-to-skin change soap 3 weeks vs. soap + aloe 5 weeks
** Conclusion: Protective effect for adding aloe to soap
* NCCTG; 1996 (1990-1991, 1992-1993) PMID 8892458 -- "Phase III double-blind evaluation of an aloe vera gel as a prophylactic agent for radiation-induced skin toxicity." (Williams MS, Int J Radiat Oncol Biol Phys. 1996 Sep 1;36(2):345-9.Related Articles, Links
** Randomized. Breast cancer patients. Two separate randomizations: Trial 1 (n=194): Arm 1) aloe vera gel vs. Arm 2) placebo gel. After negative result, Trial 2 (n=108): Arm 1) aloe vera gel vs. Arm 2) no treatment. Minimum RT dose 50 Gy. Gel applied BID on starting RT. Skin dermatitis scored weekly by patients and health-care providers
** Outcome: Trial 1: no difference between aloe vera gel and placebo. Trial 2: no difference between aloe vera gel and no treatment
** Conclusion: Aloe vera gel (and placebo gel) do not protect against radiation-induced dermatitis

### Biafine

* RTOG 99-13; 2006 (2000-2002) PMID 16648511 -- "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 EA, J Clin Oncol. 2006 May 1;24(13):2092-7.)
** Randomized, 3 arms. 547 patients with locally advanced H&N cancers. RT >=50 Gy. Arm 1) prophylactic trolamin emulsion TID starting 1st day of RT vs. Arm 2) interventional trolamine emulsion once symptomatic vs. Arm 3) declared institutional management (14 different products: Aquaphor 39%, gel 24%, cream 16%, corticosteroid 11%, other 10%)
** Outcome: Grade 2+ radiation dermatitis prophylactic arm 79% vs. interventional arm 77% vs. institutional management 79% (NS)
** Conclusion: No advantage for use of trolamin (Biafine) in reducing RT dermatitis over local standard of care
* Beilinson; 2001 (Israel) PMID 11182045 -- "Topical Biafine and Lipiderm for the prevention of radiation dermatitis: a randomized prospective trial." (Fenig E, Oncol Rep. 2001 Mar-Apr;8(2):305-9.)
** Randomized. 74 patients with BCA. Arm 1) Biafine vs. Arm 2) Lipiderm vs. Arm 3) no treatment. Ointments started 10 days prior to RT, applied BID. Endpoints evaluated were maximal skin toxicity, gaps in RT, impression of patients, subjective skin reaction, RN score and MD score.
** Outcome: No difference in all endpoints among all 3 groups
** Conclusion: Neither Biafine nor Lipiderm have a radioprotective effect
* RTOG 97-13; 2000 (1998) PMID 11121627 -- "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." (Fisher J, nt J Radiat Oncol Biol Phys. 2000 Dec 1;48(5):1307-10.)
** Randomized. 172 patients with BCA. Arm 1) Biafine vs. Arm 2) best supportive care (typically Aquaphor or Aloe Vera). Biafine applied TID, starting after first treatment.
** Outcome: No difference. RTOG 0 Biafene 9% vs. BCS 7%; RTOG 1 50% vs. 58%; RTOG 2 41% vs. 32%; RTOG 3 0% vs. 3% (NS).
** Large breast size: Biafine better. RTOG 0 Biafene 52% vs. BCS 10%; RTOG 1 48% vs. 80%; RTOG 2 0% vs. 10%
** Conclusion: No overall difference between Biafine and best supportive care

### Hyaluronic Acid

* Switzerland; 1997 PMID 9106924 -- "Double-blind, randomized clinical study comparing hyaluronic acid cream to placebo in patients treated with radiotherapy." (Liguori V, Radiother Oncol. 1997 Feb;42(2):155-61.)
** Randomized. 134 patients with H&N, breast, or pelvic CA. Arm 1) hyaluronic acid cream vs. Arm 2) placebo. mean RT dose 62 Gy
** Outcome: acute radio-epithelitis significantly lower with hyaluronic acid. Both patient and physician preference for hyaluronic acid. No difference in tolerance
** Conclusion: Prophylacit hyaluronic acid reduces high grade dermatitis

### Dexpanthenol (Bepanthen)

* Norwegian Radium Hospital; 1996 PMID 9023388 -- "Skin treatment with bepanthen cream versus no cream during radiotherapy--a randomized controlled trial." (Lokkevik E, Acta Oncol. 1996;35(8):1021-6.)
** Randomized. 79 patients, breast (n=63) and H&N (n=16). Arm 1) dexpanthenol cream vs. Arm 2) nothing. Applied on parts of treatment field for each patient.
** Outcome: No difference by EORTC/RTOG grade or itching/pain
** Conclusion: No clinically important benefit for using Bepanthen cream

### Sucralfate cream

* Dundee; 2004 (UK) PMID 15542162 -- "Does aqueous or sucralfate cream affect the severity of erythematous radiation skin reactions? A randomised controlled trial." (Wells M, Radiother Oncol. 2004 Nov;73(2):153-62.)
** Randomized, 3 arms. 357 patients with H&N, breast, or anorectal CA. Arm 1) aqueous cream vs. Arm 2) sucralfate cream vs. Arm 3) no creme. Start first day of RT. Wash using unperfumed soap
** Outcome: No difference among 3 groups. Predictors smoking, higher BMI, concurrent chemo, or bolus
** Conclusion: No benefit for prophylactic aqueous or sucralfate cream
* Helsinki; 1994 PMID 8204277 -- "Skin protection by sucralfate cream during electron beam therapy." (Maiche A, Acta Oncol. 1994;33(2):201-3.)
** Randomized. 50 patients with BCA, receiving PMRT electrons to chest wall. Arm 1) sucralfate cream vs. Arm 2) base cream
** Outcome: Significant prevention of acute dermatitis; significantly faster recover of skin
** Conclusion: Sucralfate cream significantly better than base cream

### Skin powder

* Tuebingen; 2002 PMID 12122788 -- "Intraindividual comparison of two different skin care conceptions in patients undergoing radiotherapy of the head-and-neck region. Creme or powder?" (Schreck U, Strahlenther Onkol. 2002 Jun;178(6):321-9.)
** Randomized. 12 patients with H&N. Arm 1) creme vs. Arm 2) powder. Each patient would treat 1/2 neck with creme and other half with powder.
** Outcome: No difference
** Conclusion: No difference between cream and powder

### Vitamin C

* CNS Cancer Consortium; 1993 PMID 8514538 -- "A double-blind, randomized, prospective trial to evaluate topical vitamin C solution for the prevention of radiation dermatitis. CNS Cancer Consortium." (Halperin EC, Int J Radiat Oncol Biol Phys. 1993 Jun 15;26(3):413-6.)
** Randomized. 65 patients with primary/metastatic brain tumors. Arm 1) topical ascorbic acid solution vs. Arm 2) control. All patients both treatments; applied on one vs. other side of head.
** Outcome: No difference in patient preference, or toxicity score
** Conclusion: No benefit for ascorbic acid

### Chamomile cream

* Helsinki; 1991 PMID 2036252 -- "Effect of chamomile cream and almond ointment on acute radiation skin reaction." (Maiche AG, Acta Oncol. 1991;30(3):395-6.)

### Corticosteroids

* Uppsala; 2001 (Sweden) PMID 11369066 -- "Potent corticosteroid cream (mometasone furoate) significantly reduces acute radiation dermatitis: results from a double-blind, randomized study." (Bostrom A, Radiother Oncol. 2001 Jun;59(3):257-65.)
** Randomized. 49 patients with BCA. Arm 1) mometasone furoate cream (moderately potent) vs. Arm 2) emollient cream. Applied twice/week until 12th fraction, then daily. Both groups non-blinded emollient cream daily
** Outcome: MMF decreased acute radiation dermatitis (SS); no difference in pigmentation
** Conclusion: Adding MMF to emollient is more effective than emollient alone
* Penn State; 1982 PMID 7079509 -- "Prophylaxis of radiation dermatitis with a topical cortisone cream." (Potera ME, Radiology. 1982 Jun;143(3):775-7.)
** Randomized. 19 patients (H&N, chest wall, abdomen). Arm 1) 0.2% hydrocortisone valerate vs. Arm 2) placebo. Applied hydrocortisone to 1/2 treatment field and placebo to other 1/2, starting 2 weeks after initiating RT. RT dose 27.4-62.8 Gy
** Outcome: No difference in acute skin response, or dermatitis symptoms. No difference in late effects
** Conclusion: No benefit for prophylactic 0.2% hydrocortisone
* Sweden; 1967 PMID 4864308 -- "Topical treatment of radiation dermatitis with bethamethasone-17-valerate, vaseline and eucerine--a double-blind comparison." (Bjornberg A, Clin Radiol. 1967 Oct;18(4):463-4.)
* Germany; 1959 PMID 13659285 -- "[Radiation reaction of the skin in the use of glucocorticoids.]" [Article in German] (Huter KA, Strahlentherapie. 1959 Mar;108(3):475-7.)

### Hair Washing

* Royal Marsden; 2000 (UK) PMID 10699472 -- "Advice on hair and scalp care during cranial radiotherapy: a prospective randomized trial." (Westbury C, Radiother Oncol. 2000 Feb;54(2):109-16.)
** Randomized. 109 patients undergoing cranial RT. Arm 1) no hair washing vs. Arm 2) routine hair washing. Recorded diary card showed lower frequency in Arm 1
** Outcome: No difference in acute skin reactions
** Conclusion: Normal hair washing does not increase adverse skin reactions

### Skin Washing

* Quebec; 2001 (Canada) PMID 11230896 -- "The impact of skin washing with water and soap during breast irradiation: a randomized study." (Roy I, Radiother Oncol. 2001 Mar;58(3):333-9.)
** Randomized. 99 patients with BCA. Arm 1) no washing vs. Arm 2) washing with water/soap.
** Outcome: Moist desquamation no washing 33% vs. washing 14%. Median scores for pain, itching, burning higher in no washing group though (NS)
** Conclusion: Washing irradiated skin during RT should not be discouraged
* Clatterbridge; 1992 (UK) PMID 1554631 -- "Can patients wash during radiotherapy to the breast or chest wall? A randomized controlled trial." (Campbell IR, Clin Oncol (R Coll Radiol). 1992 Mar;4(2):78-82.)
** Randomized, 3 arms. 99 patients with BCA, some treated with bolus. Arm 1) not washing vs. Arm 2) washing with water alone vs. Arm 3) washing with soap and water.
** Outcome: Subjective and objective measurements less in the two groups randomized to washing, regardless of bolus
** Conclusion: Washing of skin should be encouraged in low skin doses