Clinical trials investigating the management of radiation-induced side effects
Radiation Therapy causes unavoidable acute side effects such as skin reactions, mouth ulcers, cystitis and diarrhoea. Such side effects can substantially impact on patients' wellbeing and quality of life. There is currently no consensus worldwide how best to manage radiation-induced side effects. As radiation therapists see their patients every day for many weeks, they are often best placed to assist patients with managing these side effects. Therefore our department runs a series of small clinical trials investigating ways to reduce the severity of these acute side effects.
Honours students liaise with the patients and complete the data collection; they are also responsible for the analysis of data at their own centre and will write this up as a thesis, which is assessed by an external and internal examiner. Every effort is made to facilitate honours students presenting at national and international conferences and to publish their data in relevant journals.
Radiation-induced skin reactions in breast and head and neck cancer patients
1. Mepilex Lite trial I
Research question: Do Mepilex Lite dressings decrease the extent of radiation-induced erythema in breast cancer patients, compared with aqueous control cream?
Academic Supervisor: Dr Patries Herst
Clinical Supervisor: Noelle Bennett
Student: Katie Diggelmann (Southern Blood and Cancer Centre, Dunedin)
Publication: Diggelmann, K.V., Zytkovicz, A.E., Tuaine, J.M., Bennett, N.C., Kelly, L.E., Herst, P.M. Mepilex Lite dressings for the management of radiation-induced erythema: a systematic inpatient controlled clinical trial. Br J Radiol. 83(995): 971-934 (2010).IF 2.366.
Abstract:
Purpose: Erythema occurs in 80-90% of women treated for breast cancer with radiation therapy. There is currently no standard treatment for radiation-induced skin reactions. This study investigates the clinical efficacy of Mepilex Lite dressings in reducing radiation-induced erythema in women with breast cancer.
Methods and Material: A total of 30 patients were recruited; of these, 24 participants presented with 34 erythematous areas of skin for analysis. When erythema was visible, each affected skin area was randomly divided into two similar halves; one half was treated using Mepilex Lite dressings, the other half with standard aqueous cream. Skin reactions were assessed by Radiation-Induced Skin Assessment Scale. We also evaluated any potential dose build-up by the dressings using a white water phantom, the dose distribution over the breast via thermoluminescent dosimeters (TLDs) and the surface skin temperature with an infrared thermographic scanner.
Results: Mepilex Lite dressings significantly reduced the extent of radiation-induced skin reactions compared to standard aqueous cream (p=0.006), did not affect surface skin temperature and caused only a small (0.5 mm) dose build-up. TLD measurements showed that the inframammary fold was exposed to significantly higher doses of radiation than any other breast region (p<0.0001).
Conclusions: Mepilex dressings reduce radiation-induced erythema.
2. Mepilex Lite trial II
Research question: Do Mepilex Lite dressings decrease the incidence of radiation-induced moist desquamation in breast cancer patients post-mastectomy, compared with aqueous control cream?
Academic Supervisor: Dr Patries Herst
Clinical Supervisors: Noelle Bennett, Hannah Thompson, Jennifer de Ridder, Denise Redwood
Students: Dean Patterson (Wellington Blood and Cancer Centre) and Prashika Poonam (MidCentral Health, Palmerston North). Other centres involved: Southern Blood and Cancer Centre Dunedin (Annie Sutherland) and Auckland Radiation Oncology (Meredith van Beekhuizen)
Publication: Paterson, D.B., Poonam, P., Bennett, N. C., Peszynski, R.I., van Beekhuizen, M., Jasperse, M.L., Herst, P.M. Randomized intra-patient controlled trial of Mepilex Lite dressings versus aqueous cream in managing radiation-induced skin reactions postmastectomy. J Cancer Sci Ther 4: 347-356 (2012). IF 5.828
Abstract:
Purpose: Severe acute radiation-induced skin reactions occur in a significant proportion of women who receive radiation therapy for breast cancer. We previously showed that Mepilex Lite dressings decreased the severity of erythema. Here we report their effect on the full range of skin reactions in 74 breast cancer patients post-mastectomy.
Methods and Material: A total of 80 women were recruited from four hospitals in New Zealand with 74 women contributing a full data set for analysis. The first skin area on the chest wall to develop erythema was randomly divided into two similar halves; one half was treated with Mepilex Lite dressings, the other half with aqueous cream. Skin reactions were assessed using the Radiation-Induced Skin Reaction Assessment Scale.
Results: Compared with aqueous cream, Mepilex Lite dressings reduced the overall severity of the skin reactions by 40% (p<0.001), the incidence of moist desquamation from 16% to 9%, the total moist desquamation time for all patches combined from 28 to 14 weeks and increased the time to developing moist desquamation (from 37 ± 1.7 to 47 ± 3.5 days; p=0.015).
Conclusions: Mepilex Lite dressings reduce all aspects of radiation-induced skin reactions and half the overall moist desquamation time.
3. Mepitel Film trial I
Research question: Does Mepitel Film decrease the incidence of radiation-induced moist desquamation in breast cancer patients, compared with aqueous control cream?
Academic Supervisor: Dr Patries Herst
Clinical Supervisors: Noelle Bennett
Student: Annie Sutherland
Publication: Herst, P.M.,* Bennet, N.C., Sutherland, A.E., Peszynski, R.I., Paterson, D.B., Jasperse, M.L. Prophylactic use of Mepitel Film completely prevents radiation-induced moist desquamation in an intra-patient controlled RCT of 78 breast cancer patients in New Zealand. Radiother Oncol 2014 Jan;110(1):137-43. doi: 10.1016/j.radonc.2014.01.005.
Abstract:
Purpose: Safetac-based soft silicone dressings used in a management setting decrease the severity of radiation-induced acute skin reactions but do not affect moist desquamation rates. Here we investigate the prophylactic use of another Safetac product, Mepitel Film, on moist desquamation rates.
Material and Methods: A total of 80 breast cancer patients receiving radiation therapy were recruited between October 2012 and April 2013; 78 participants contributed data for analysis. Lateral and medial halves of the skin areas to be irradiated were randomized to Mepitel Film or aqueous cream; skin dose was measured using thermoluminescent dosimeters; skin reaction severity was assessed using RISRAS and RTOG scales.
Results: Overall skin reaction severity was reduced by 92% (p<0.0001) in favour of Mepitel Film (RISRAS). All patients developed some form of reaction in cream-treated skin which progressed to moist desquamation in 26% of patients (RTOG grades I: 28%; IIA: 46%; IIB: 18%; III: 8%). Only 44% of patients had a skin reaction under the Film, which did not progress to moist desquamation in any of the patients (RTOG grades I: 36%; IIA: 8%).
Conclusions: Mepitel Film completely prevented moist desquamation and reduced skin reaction severity by 92% when used prophylactically in our cohort
4. Mepitel Film trial II
Research question: Does Mepitel Film decrease the incidence of radiation-induced moist desquamation in head and neck cancer patients, compared with aqueous control cream?
Academic Supervisor: Dr Patries Herst
Clinical Supervisors: Noelle Bennett, Iain Ward
Student: Hayley Bennett. Other centres involved: Southern Blood and Cancer Centre Dunedin (Jo Tuaine, Kylie Hewitt), Calgary, Alberta, Canada (Safiya Mohamed).
Patient recruitment: opened April 2015
Oral Mucositis in head and neck cancer patients
Research question: Does Manuka honey, in addition to standard care decrease the onset and extent of radiation-induced mouth ulcers in head and neck patients, compared with standard care alone?
Academic Supervisor: Dr Patries Herst
Clinical Supervisors: Jennifer de Ridder and Hannah Thompson
Students: Aubrey Begley (Wellington Blood and Cancer Centre) and Emma Parsons (MidCentral Health, Palmerston North). Other centre involved: Southern Blood and Cancer Centre Dunedin (Jo Tuaine).
Publication: Parsons, E., Begley, A., Herst, P. Manuka honey mouthwash does not affect oral mucositis in head and neck cancer patients in New Zealand. J Radiother Pract. 11, 249-256 (2012).
Abstract:
Oral mucositis is an unavoidable side effect of radiation therapy to the head and neck which can compromise patient health and quality of life. This study investigates the effect of manuka honey on the extent of oral mucositis in head and neck patients in New Zealand. A total of 28 patients were recruited; 10 patients received standard care and 18 patients were given additional manuka honey. Honey was used three times a day, assessment included: extent of oral mucositis using a multi-site mucositis scoring system, weight and quality of life. The first six patients randomized to the honey arm, used undiluted honey and pulled out in the first week because of extreme nausea, vomiting and stinging sensations in the mouth. The next 12 honey patients used a honey mouthwash (diluted 1:3). Six of these patients completed the trial and four more completed the first 4 weeks of the trial. Eight control patients completed the trial. In contrast to previous studies in Malaysia, Egypt, Iran and India undiluted honey was not tolerated. Honey mouthwash did not affect the extent of oral mucositis.
Radiation Cystitis in prostate cancer patients
Research question: Do cranberry capsules decrease the extent of radiation-induced cystitis in prostate cancer patients, compared to placebo control capsules?
Academic Supervisor: Dr Patries Herst
Clinical Supervisor: Noelle Bennett
Student: Katelin Hamilton (Southern Blood and Cancer Centre, Dunedin)
Publication: Hamilton, K.A., Bennett, N.C., Purdie, G.L., Herst, P.M. Standardized cranberry capsules for radiation cystitis in prostate cancer patients in New Zealand: a randomized double blinded placebo controlled pilot study. Supportive Care in Cancer, Support Care Cancer. 2015 Jan;23(1):95-102. doi: 10.1007/s00520-014-2335-8. Epub 2014 Jul 4.
Abstract:
Purpose: Acute radiation cystitis is a common side effect in men receiving external beam radiation for prostate cancer. There is currently no effective treatment to prevent or treat radiation cystitis. Cranberry products have been associated with urinary tract health. The aim of this study was to determine the effect of highly standardized cranberry capsules (containing 72mg PACS) with that of placebo capsules on the incidence and severity of radiation cystitis.
Methods: A total of 41 men with prostate cancer participated in a double blinded randomized placebo controlled study in Dunedin. Men took one capsule a day at breakfast during treatment and for two weeks after treatment completion. Severity of urinary symptoms and their effect on health-related quality of life were measured using the individual items of the urinary domain of the Modified Expanded Prostate Index Composite (EPIC).
Results: The incidence of cystitis was lower in men taking cranberry capsules (65%) compared with those that took placebo capsules (90%); severe cystitis was seen in 30% of men in the cranberry arm and 45% in the placebo arm. Overall, the incidence of pain/burning was significantly lower in the cranberry cohort.
Conclusion: Men receiving radiation therapy for prostate cancer may benefit from using cranberry capsules, particularly those on low hydration regimens or presenting with urinary symptoms before radiation treatment.