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DEAD SEA PRODUCTS "Dr. Nona Int./מחקר על השפעת מוצרי ד"ר נונה במחלקה האונקולוגית באיכילוב תל אביב

מאמרים
מחקר על השפעת מוצרי ד"ר נונה במחלקה האונקולוגית באיכילוב תל אביב

  
.מחקר שנעשה במחלקה האונקולוגית במרכז הרפואי סוראסקי, בית חולים איכילוב בתל אביב
על מוצרי ד"ר נונה והטיפול בהפחתת הרעילות בריריות ועור הראש והצוואר אונקולוגים  בטיפולי הקרנות

 

"DEAD SEA PRODUCTS "Dr. Nona Int." in the treatment of radiotherapy-induced toxicity in mucosa and skin of head and neck cancer patients.

 

General menager of this project Dr. Nona Kuchina
PI: Dr. Rami Ben Yosef 
CI: Dr. Akiva Vexler and Dr. Diana Matceyevsky
Radiotherapy Unit, Division of Oncology, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel

Introduction:

Mucositis is a frequent debilitating complication presented in patients receiving radiotherapy to the head and neck tumors (1). The inflammation of the mucosa ranges from redness to severe ulceration. Symptoms of mucositis vary from pain and discomfort to an inability to tolerate food or fluids. It may initiate opportunistic infections in the mouth and the upper digestive tract. All this may limit the patient's ability to tolerate radiotherapy and hence to limit the effectiveness of cancer therapy.It is therefore crucial that mucositis should be prevented whenever possible, or at least treated to reduce its severity and possible complications. Unmet needs in the area of mucositis include therapies that prevent or reduce the severity, duration, and symptoms of mucositis so the patient's radiation regimen can be maintained. In addition the treatment might reduces hospitalization, narcotic use, or a need for nutritional support.Skin toxicity. Secondary to irradiation the skin in the involved fields may exhibit side effects that range from mild burn to necrosis and ulceration. The skin toxicity is heavily dependent on the irradiation dose and usually presents in skin fields as axilla and neck. In severe skin damage a break in the treatment schedule should be carried out and hence may cause a treatment failure.Currently there is no medication which have a clear cut benefit in the treatment of radiation induced damage to the skin or mucosal membranes. Recently a phase III study, carried by RTOG group, has concluded that Biafine - the most used cream in radiotherapy wards - is ineffective (2). Similar multi-center studies on the use of either oral mouthwash or anti-microbial solutions found to be ineffective (3,4).Dead Sea products contain various minerals and other materials and have a confirmed effectiveness in treating various skin diseases as psoriasis. We conducted a pilot study to examine the effectiveness of Dead Sea products - moisturizing cream (Solaris) and mouthwash, manufactured by "Dr. Nona" company, on treating skin and mucosal toxicity seen in patients treated with radiotherapy to head and neck tumors. "Dr. Nona" products are permitted for use either as cosmetic products or as a food supplement. Several clinical studies and animal evaluations (carried out in several countries from the former USSR) showed its safety and possible effectiveness in treating radiation induced skin and mucous membrane toxicity.

Patients and Methods: Patients with head and neck tumors (oral cavity, oropharynx, hypopharynx, larynx, salivary glands) were recruited for this study during. The trial group included 15 patients and the control group included 30 patients that were matched by tumor site and radiotherapy protocol. The irradiation was delivered using a linear accelerator (Elekta) operated in 6 MV photon beam. The total dose varied from 52 - 72 Gy and the dose per fraction was 1.8-2.0 Gy.

The Dead Sea products tested were the mouthwash and the cream "Solaris". Both were used three times daily: one week before, during and two weeks after radiotherapy. Patients' conditions were checked once a week during the treatment and up to three weeks after the completion of the treatment. Skin and mucosal toxicity was measured using the RTOG toxicity (1998) criteria. The overall treatment time was documented in all patients and treatment breaks ( 3 days ) due to acute mucositis were recorded. All raw data presented in 2 tables (see Appendix) and summarized the tables inside the report. The local ethical committee approved this study.

Table 1. RTOG acute radiation morbidity scoring criteria.

Organ Tissue Grade 0 Grade 1 Grade 2 Grade 3 Grade 4
Mucous membrane no change may experience mild pain not requiring analgesic patchy mucositis that may produce an inflammatory serosanguinous discharge; may experience moderate pain requiring analgesic Confluent fibrinous mucositis; may include severe pain requiring narcotic Ulceration, hemorrhage or necrosis
Salivary gland no change mild mouth dryness; slightly thickened saliva; may have slightly altered taste such as metallic taste; these changes not reflected in alteration in feeding behavior, such as increased use of liquids with meals Moderate to complete dryness; thick, sticky saliva; marked altered taste -- acute salivary gland necrosis
Pharynx & esophagus no change mild disphagia or odynophagia; may require topical anesthetic or non-narcotic analgesics; may require soft diet Moderate dysphagia or odynophagia; may require narcotic analgesics; may require puree or liquid diet severe dysphagia or odynophagia with dehydration or weight loss (>15% from pre-treatment base-line; requiring N-G feeding tube, i.v. fluids or hyperalimentation complete obstruction, ulceration, perforation, fistula
Larynx no change mild or intermittent hoarseness; cough not requiring antitussive; erythema of mucosa persistent hoarse-ness but able to vocalize; referred ear pain, sore throat, patchy fibri-nous exudates or mild arythenoid edema not requiring narcotics; cough requiring antitussive whispered speech, throat pain or referred ear pain requiring narcotic; confluent fibrinous exudates, marked arytenoid edema marked dyspnea, stridor or hemoptysis, tracheostomy or intubation necessary
Skin no change follicular, faint or dull erythema, epilation, dry desquamation, decreased sweating tender or bright erythema, patchy moist desqua-mation, moderate edema confluent, moist desquamation other than skin folds, pitting edema Ulceration, hemorrhage, necrosis

Results:

The characteristics of patients included in this study are presented in Tabs A&B and summarized in corresponding tables. The designed protocol of treatment with Dead Sea products was given to 17 patients from whom one was excluded as changed the place of treatment and the second patient died at the beginning of the treatment from the reasons not connected to the protocol. Therefore, the trial group was analyzed as the group of 15 patients. The control group consisting from 30 patients was very similar to the trial group.

Table 2. Patients' characteristics.

  Control Group Trial Group
No. of patients 30 15
No. of patients 60.4 64.1
Total dose (cGy) 5000-7500 5940-7020
Dose/fraction (cGy) 180 or 200 180 or 200
Chemotherapy 8 (27%) Pts 5 (33%) Pts

 

In both groups of patients we observed the side effects following radiation therapy (Tab. 3). In the trial group only mucositis of grade I-II was noted: 9 patients had mucositis of grade I and 3 patients - mucositis of grade II. No one patient in this group had mucositis of grade III-IV. All patients tolerate radiation treatment quite well and do not have any discomfort attributed to Dead Sea Products. In the control group mucositis was much more observable: 14 patients had mucositis of grade I and 6 patients had mucositis of grade II. Mucositis of grade III-IV was revealed in 3 patients

Table 3. Side effects in the patients received radiotherapy.

Side effects Grade Control Group Trial Group
Mucositis I 14 9
  II 6 3
  III 2 0
  IV 1 0
Skin damage I 4 9
  II 6 0
  III 2 0
  IV 1 0

In the trial group only skin damage of grade I was noted in 9 patients (Tab. 3). In the control group the skin damage of grade I-II was noted in 10 patients and of grade III-IV in 3 patients.

The radiation-induced side effects revealed in both groups lead to a treatment break. But it has to be underlined that the toxicity rate in the trial group was significantly lower than in control group. Therefore, in the trial group only 3 (20%) patients had the break in the treatment but in the control group the treatment break was seen in 12 (40%) patients (Table 4).

Conclusions: Dead Sea products - cream "Solaris" and mouthwash - used for the minimizing of radiotherapy-induced toxicity in patients with head and neck tumors seem to decrease the mucosa and skin-induced toxicity and therefore to improve patients' tolerability to radiotherapy.

Table 4. Treatment breaks in the patients received radiotherapy.

Control Group Control Group Trial Group Trial Group
Patients with breaks Break duration (days Patients with breaks Break duration (days
11 5 7 3
2 12 10 21
4 19 12 21
7 26    
8 19    
11 12    
16 12    
18 6    
22 19    
26 6    
28 33    
30 12    
12 pts 15.1 3 pts 15.0
40%   20%  

Acknowledgments 
This study was initiated and financed by CLINICA LENOM Ltd. We thank Mr. G. Shneerson, the General Director of Clinica Lenom Ltd., and Mr. M. Shneerson, the President of Dr. Nona International Ltd., for full support and assistance to this research.

References
1. Trotti A., Bellm L.A., Epstein J.B., Frame D., Fuchs H.J., Gwede C.K., Komaroff E., Nalysnyk L., ZilberbergM.D. Mucositis incidence, severity and associated outcomes in patients with head and neck cancer receiving radiotherapy with or without chemotherapy: a systematic literature review. Radiotherapy and Oncology 2003; 66: 253-262. 
2. Szumacher E., Wighton A., Franssen E., et al. Phase II study assessing the effectiveness of the Biafine cream as a prophylactic agent for radiation-induced acute skin toxicity to the breast in women undergoing radiotherapy with concomitant CMF chemotherapy. Int. J. Radiation Oncology Biol. Phys. 2001; 51: 81-86.
3. Kצstler W.G., Hejna M., Wenzel C., and Zielinski C.C. Oral Mucositis Complicating Chemotherapy and/or Radiotherapy: Options for Prevention and Treatment. CA Cancer J. Clin. 2001; 51: 290-315.
4. El-Sayed S., Nabid A., Shelley W., Hay J., Balogh J., Gelinas M., MacKenzie R., Read N., Berthelet E., Lau H., Epstein J., Delvecchio P., Ganguly P.K., Wong F., Burns P., Tu D., Pater J. Prophylaxis of radiation-associated mucositis in conventionally treated patients with head and neck cancer: a double-blind, phase III, randomized controlled trial evaluating the clinical efficacy of an antimicrobial lozenge using a validated mucositis scoring system. J. Clin. Oncol. 2002; 20: 3956-963.