Sucralfate

Sucralfate

PEP Topic 
Radiodermatitis
Description 

Sucralfate is an ulcer drug that has an anti-inflammatory effect on the gastrointestinal mucosa. The drug causes an increase in the level of prostaglandins and binds basic fibroblast growth factor (bFGF), protecting it from acid degradation. It is angiogenic, increasing blood flow. Systemic use with oral administration has been studied for diarrhea, mucositis, and radiodermatitis. Topical use has been tested as an intervention for radiodermatitis.

Effectiveness Not Established

Research Evidence Summaries

Falkowski, S., Trouillas, P., Duroux, J. L., Bonnetblanc, J. M., & Clavère, P. (2011). Radiodermatitis prevention with sucralfate in breast cancer: fundamental and clinical studies. Supportive Care in Cancer, 19, 57–65.

doi: 10.1007/s00520-009-0788-y
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Study Purpose:

To determine if sucralfate has a role in the prevention of radiodermatitis. A 1% concentration of sucralfate in lotion was tested.

Intervention Characteristics/Basic Study Process:

Several zones on the breast were laid out by the investigators, with one zone in the irradiated field left untreated, one with sucralfate, and one that was not within the field of radiation therapy (RT). All patients were instructed to apply sucralfate lotion twice a day, one to two hours prior to treatment and within two hours after RT.

Sample Characteristics:

  • The sample was comprised of 21 women with breast cancer.
  • Median age was 58.3 years.
  • Patients were receiving no concomitant chemotherapy treatment.
  • The treatment dose was 45 Gy.

 

Setting:

Unspecified

Study Design:

The study used a quasiexperimental design—patients were used as their own controls.

Measurement Instruments/Methods:

  • Spectrophotometry was used to measure the response of skin on all zones compared to the zone that was not within the field of RT. Differences between the control radiated zone and the control zone that was not within the field of RT were analyzed. Changes in brightness and skin tonality were used to indicate the degree of erythema.
  • Radiation Therapy Oncology Group (RTOG) acute skin toxicity scale
  • Patients were evaluated once a week at 10 Gy, 20 Gy, 30 Gy, 40 Gy, and 50 Gy.
  • Additional variables included prior surgery, tumor location, prior chemotherapy, skin phototype, other cutaneous diseases, and systemic diseases.

Results:

  • Skin became darker and redder by spectrophotometry with irradiation for all patients, with maximum skin response at weeks 4 and 5.
  • No differences existed in redness between sucralfate-treated and untreated areas.
  • Six patients had skin reactions between weeks 4 and 5 that were graded I and II on the RTOG scale.
  • Researchers suggested that the use of spectrophotometry was more effective than the RTOG scale for evaluation of skin changes.

 

Conclusions:

No radioprotective effect was demonstrated with sucralfate.

Limitations:

  • The study had a small sample size.
  • The authors did not state who did the rating/skin examination, and actual RTOG scale results were not reported.
  • Other studies have used a higher concentration of sucralfate (7%).

Lievens, Y., Haustermans, K., Van den Weyngaert, D., Van den Bogaert, W., Scalliet, P., Hutsebaut, L., . . . Lambin, P. (1998). Does sucralfate reduce the acute side-effects in head and neck cancer treated with radiotherapy? A double-blind randomized trial. Radiotherapy and Oncology, 47, 149–153.

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Study Purpose:

To determine the efficacy of oral sucralfate in reducing radiation (RT)-induced acute complications in the treatment of patients with head and neck cancer. This study looked at mucositis and dermatitis.

Intervention Characteristics/Basic Study Process:

Patients were given oral sucralfate at a dose of 1 gm six times a day from the onset of RT and continued during the entire treatment.

Sample Characteristics:

  • The sample was comprised of 83 patients.
  • Age and gender were not provided.
  • Patients had head and neck cancer.
  • Patients were treated to 55 Gy in five weeks.

Setting:

Two sites in Belgium

Study Design:

The study was a randomized, placebo-controlled, double-blind trial.

Measurement Instruments/Methods:

Dermatitis scoring scale:

  • 0 = none
  • 1 = slight erythema
  • 2 = deep erythema
  • 3 = dry desquamation
  • 4 = spotted epidermolysis
  • 5 = confluent epidermolysis
  • 6 = necrosis

Other variables analyzed were weight, tumor site, and stage; subjective tolerance; dysphagia; nausea and vomiting; dermatitis; mucositis; total dose; and daily fractionation schedule.

Results:

Of the initial 102 patients randomized, only 83 were evaluable due to issues of patient nonadherence to the protocol. Compliance was worse in the sucralfate group. There were no differences in mean scores for dermatitis or other symptoms measured between the two study groups.

Conclusions:

No clinical evidence indicated that sucralfate reduces acute RT-induced side effects.

Limitations:

  • Patients were given local anesthetics and systemic painkillers when needed, so it would be difficult to determine what actually worked.
  • Patients were not evaluated at the end of treatment.
  • Many participants did not follow protocol.
  • Use of a nonstandard tool makes comparison to other studies difficult.
  • No data were provided on gender and age.
  • No data were shown regarding total RT dose and fractionation schedule.

Maiche, A., Isokangas, O.P., & Gröhn, P. (1994). Skin protection by sucralfate cream during electron beam therapy. Acta Oncologica, 33, 201–203.

 

doi: 10.3109/02841869409098406
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Study Purpose:

To compare the efficacy of sucralfate cream to a control base cream in women receiving postoperative electron beam therapy to their chest wall

Intervention Characteristics/Basic Study Process:

Patients were randomized to apply sucralfate containing 7% micronized sucrose sulfate or equivalent base cream on either side of the scar.

Sample Characteristics:

N = 44

AGE RANGE = 33–84 years

MEAN AGE = 60 years

FEMALES: 100%

KEY DISEASE CHARACTERISTICS: Breast cancer of the chest wall

OTHER KEY SAMPLE CHARACTERISTICS: 6 MeV electron beam total dose 50 Gy—10 Gy weekly in five fractions. Surface area varied from 11 cm × 11cm–20 cm × 20 cm. The scar was situated horizontally in the middle of the portal image.

Setting:

  • SITE: Single
  • LOCATION: Helsinki, Finland

Study Design:

  • Quasi-experimental, double-blind design
    • Patients used as own controls

Measurement Instruments/Methods:

  • Adverse effects were graded on a five-point rating scale (0 = no reaction; 1 = light erythema; 2 = dark erythema, area painful; 3 = wet desquamation; 4 = necrosis of the skin).
  • Patients were interviewed for their preference of cream.

Results:

Grade 1 and 2 reactions appeared later on the areas treated with sucralfate cream. Grade 2 reactions in the entire sample were observed more often at four weeks (p = 0.01) and at five weeks (p > 0.01 but < 0.05). Recovery time of radiation-induced reactions was faster and, after finishing radiation therapy, the grade of skin reaction remained lower with the sucralfate cream than the base cream (p = 0.05).

 

Conclusions:

Sucralfate may be of benefit in reducing severity of radiation dermatitis.

Limitations:

  • No information is provided regarding patient compliance.
  • What the total dose was when checked weekly is unclear.
  • Where the rating scale came from is unclear.
  • Small sample size

Wells, M., Macmillan, M., Raab, G., MacBride, S., Bell, N., MacKinnon, K., . . . Munro, A. (2004). Does aqueous or sucralfate cream affect the severity of erythematous radiation skin reactions? A randomized controlled trial. Radiotherapy and Oncology, 73, 153–162.

doi: 10.1016/j.radonc.2004.07.032
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Study Purpose:

To investigate whether sucralfate or aqueous cream reduced acute skin toxicity during radiation therapy to head and neck, breast, or anorectal area (phase A), and to evaluate the effect of hydrogel and dry dressings on most desquamation (phase B)

Intervention Characteristics/Basic Study Process:

Patients were randomized into one of six treatment combinations.

  1. Aqueous cream/dry dressings
  2. Aqueous cream/hydrogel dressings
  3. No cream/dry dressings
  4. No cream/hydrogel dressings
  5. Sucralfate cream/dry dressings
  6. Sucralfate cream/hydrogel dressings

Patients randomized to the two creams were advised to apply a thin layer of cream to the treatment area twice daily, from the first day of radiation therapy. All patients were given identical advice about washing the treatment area and provided with a supply of perfume-free soap.

Sample Characteristics:

  • N = 357 patients remained in study (aqueous cream: 117, sucralfate cream: 120, no cream: 120)
  • AGE: Younger than 50 years: 62, 50–59 years: 121, 60–69 years: 103, older than 70 years: 71
  • MALES: 95, FEMALES: 262
  • KEY DISEASE CHARACTERISTICS: Breast cancer, head and neck cancer, anorectal cancer

Setting:

  • Western General Hospital, Edinburgh, Scotland
  • Ninewells Hospital, Dundee, Scotland

Study Design:

  • Randomized, controlled double-blind trial

Measurement Instruments/Methods:

  • Baseline skin assessments were recorded, including modified Radiation Therapy Oncology Group (RTOG) acute toxicity scale (assessed at up to seven sites within the treatment field), and a series of erythema readings were taken with a Dia-Stron meter using spectrophotometry. The meter readings in non-irradiated areas were subtracted from those in the treated area. The differences were taken as erythema readings for each patient.
  • Patients were asked to complete a quality of life questionnaire (Dermatology Life Quality Index [DLQI]) and a patient diary card, including four Likert scale questions about pain, itching, burning, and sleep disturbance.
  • The diary card also required patients to self-assess degree of erythema and desquamation seen within the treatment area using a scoring system.
  • All assessments were completed weekly until at least two weeks after completion of radiation therapy or until any skin reaction had totally healed.

Results:

Findings presented in the article are phase A only. No consistent differences were found in the severity of skin reactions or levels of discomfort between groups. Patients with higher body mass index, who smoked, or who received concomitant chemotherapy, boost, or bolus during treatment were more likely to develop skin reactions. Sucralfate cream produced significantly lower erythema readings than aqueous cream on adjusted analyses, but the group treated with no cream had even lower readings. No difference was found with survival analysis of time to moist desquamation with treatment cream concurrent chemotherapy, which significantly was associated with worse skin reactions (p = 0.006). Nonsmokers had lower skin toxicity scores than ex-smokers, with smokers having the highest scores for all measures.

Conclusions:

No evidence supports prophylactic application of either cream tested for prevention of radiation skin reactions. It is possible to predict which patients are at greatest risk of skin reactions. When consistent skin care instructions to wash with mild soap and water are given, no additional symptomatic benefit is gained by applying cream to the treatment area.

Limitations:

  • Cost analysis showed a considerable increase in the cost of supplying sucralfate cream compared with aqueous cream or no cream at all.
  • Results apply to a largely Caucasian population (two patients were not Caucasian) and cannot be extrapolated to any other ethnic groups.
  • DLQI was found to be a fairly insensitive measure in patients undergoing radiation therapy.
  • There was no discussion of the validity and reliability of the modified RTOG scale used for the study.
  • The sample size was small for the number of different treatment groups to be analyzed.

Systematic Review/Meta-Analysis

Kumar, S., Juresic, E., Barton, M., & Shafiq, J. (2010). Management of skin toxicity during radiation therapy: a review of the evidence. Journal of Medical Imaging and Radiation Oncology, 54, 264–279.

doi: 10.1111/j.1754-9485.2010.02170.x
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Purpose:

To review the evidence for skin care management and conduct a survey to assess current practices in Australia and New Zealand.

Search Strategy:

Databases searched were MEDLINE, PubMed, CINAHL, Google Scholar, and Google search. Searches were also completed by hand for the time period of 1980 to 2008.

Search keywords were radiation dermatitis, skin reaction, management, skin care, skin toxicity, moist desquamation, dry desquamation, erythema, sorbolene aqueous cream, and aloe vera.

Inclusion and exclusion criteria were not specified.

Literature Evaluated:

Thirty-one references were retrieved. Literature was evaluated on the basis of sample size. Meta-analysis was performed on studies reporting at least grade II skin toxicity.

Sample Characteristics:

  • The final number of studies included was 31.
  • The sample size across studies was 3,174 participants (range 413–506).
  • Participants had various tumor types.
  • All participants received radiation therapy (RT).

Phase of Care and Clinical Applications:

Patients were undergoing the active antitumor treatment phase of care.

Results:

Findings were reviewed for washing, topical aloe vera, topical sucralfate, Biafine cream, corticosteroids, hyaluronic acid, barrier film, dressings, and wheatgrass extract for prophylaxis. For management, interventions included were topical steroid cream, sucralfate, and dressings. Meta-analysis across studies using any topical prophylaxis showed that any intervention was associated with lower odds of development of skin toxicity (p = 0.02). There were no significant results for management interventions. There was consistent evidence in favor of gentle washing with mild soap during RT. There was some evidence in support of corticosteroids, bepanthan, topical hyaluronic acid, calendula, and barrier films. Aloe vera was associated with higher toxicity.

Conclusions:

Evidence did not support the use of sucralfate, Biafine, or dressing for prevention. Evidence regarding interventions for management of skin toxicity was conflicted, and none produced significant effects. Findings support the use of washing. There was some evidence in support of using corticosteroids, bepanthan, barrier films, calendula, and topical hyaluronic acid. Findings suggest that use of any topical therapy for prophylaxis may be more effective than no intervention.

Limitations:

  • Analysis was limited by combining all types of interventions together, which did not allow for differentiation between those agents individually shown to be effective and not effective.
  • Methods for evaluation of the quality of the research were not well described or incorporated into the analysis. 
  • Findings regarding management were questionable because of high heterogeneity among studies included in the meta-analysis. 
  • Actual odds ratios or effect sizes from the meta-analysis were not reported. 
  • Final recommendations stated by the authors were not consistent with the rest of the conclusions stated elsewhere in the article. 
  • The basis for recommendations, concerning evaluation of the quality of the evidence, was not clear. 
  • The authors stated that they weighted studies by sample size, but this method was not described.

Nursing Implications:

Washing during RT should not be restricted. There is some evidence in support of using calendula, hyaluronic acid, no-sting barrier film, bepanthan, and topical steroids. Evidence does not support the use of aloe vera.

Salvo, N., Barnes, E., van Draanen, J., Stacey, E., Mitera, G., Breen, D., . . . De Angelis, C. (2010). Prophylaxis and management of acute radiation-induced skin reactions: A systematic review of the literature. Current Oncology (Toronto, Ont.), 17(4), 94–112.

Print

Purpose:

To review the evidence for approaches to prevention and management of radiodermatitis

Search Strategy:

Databases used were MEDLINE, PubMed, and Cochrane Library. Keywords searched were skin reactions, radiation, radiation adverse effects, erythema, desquamation, and radiodermatitis. Studies were included in the review they

  • Were published reports or abstracts from January 1, 2000 to October 1, 2008.
  • Reported the method of skin grading.

Studies were excluded from the review if they were letters, comments, editorials, case reports, practice guidelines, systematic reviews, or meta-analyses.
 

Literature Evaluated:

The total references retrieved and the quality rating approach were not reported.
 

Sample Characteristics:

  • Thirty-nine trials were included in the review.
  • Patients were receiving radiation therapy.

Phase of Care and Clinical Applications:

Patients were undergoing active antitumor treatment.

Results:

Washing practice, topical corticosteroids, aloe vera, biafine, hyauronidase-based creams, sucralfate, miscellaneous creams, Amifostine, oral enzymes, pentosifylline, dressings, non-steroidal topical cream, topical colony-stimulating factors supplements, and mode of radiation delivery were reviewed. Other agents studied included beladonna 7CH and a Chinese remedy, lian bai liquid.

Conclusions:

There is lack of support for Biafine use. There is some evidence to suggest that topical corticosteroids may be beneficial. Evidence for non-steroidal topical agents is conflicting. Evidence does not support use of Aloe Vera or sucralfate cream. Some evidence to suggest that light-emitting diode, pentoxifylline, sliver-leaf dressings, washing, zinc supplements and intensity-modulated radiation therapy are beneficial.

Limitations:

  • The trials were small and had numerous design and reporting limitations.
  • Secondary trials evaluated the same agent or treatment, making comparison very difficult.

Nursing Implications:

Further research is needed in this area. Intervention goals, prevention or treatment need to be clear and further work is needed to develop and validate more sensitive assessment tools. Further work is also needed to evaluate differences in risk based on anatomical sites.


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