Phase III randomized trial of Calendula officinalis compared with trolamine for the prevention of acute dermatitis during irradiation for breast cancer. Honey as topical prophylaxis against radiochemotherapy-induced mucositis in head and neck cancer. [Prevention of stomatitis induced by anti-cancer drugs]. Prophylaxis with GM-CSF mouthwashes does not reduce frequency and duration of severe oral mucositis in patients with solid tumors undergoing high-dose chemotherapy with autologous peripheral blood stem cell transplantation rescue: a double blind, randomized, placebo-controlled study.
The effectiveness of nonsteroid topical agents for the prevention of acute dermatitis during adjuvant radiotherapy for breast carcinoma has not been demonstrated. The goal of this study was to compare the effectiveness of calendula (Pommade au Calendula par Digestion; Boiron Ltd, Levallois-Perret, France) with that of trolamine (Biafine; Genmedix Ltd, France), which is considered in many institutions to be the reference topical agent.
                Between July 1999 and June 2001, 254 patients who had been operated on for breast cancer and who were to receive postoperative radiation therapy were randomly allocated to application of either trolamine (128 patients) or calendula (126 patients) on the irradiated fields after each session. The primary end point was the occurrence of acute dermatitis of grade 2 or higher. Prognostic factors, including treatment modalities and patient characteristics, were also investigated. Secondary end points were the occurrence of pain, the quantity of topical agent used, and patient satisfaction.
                The occurrence of acute dermatitis of grade 2 or higher was significantly lower (41% v 63%; P <.001) with the use of calendula than with trolamine. Moreover, patients receiving calendula had less frequent interruption of radiotherapy and significantly reduced radiation-induced pain. Calendula was considered to be more difficult to apply, but self-assessed satisfaction was greater. Body mass index and adjuvant chemotherapy before radiotherapy after lumpectomy were significant prognostic factors for acute dermatitis.
                Calendula is highly effective for the prevention of acute dermatitis of grade 2 or higher and should be proposed for patients undergoing postoperative irradiation for breast cancer. To evaluate the efficacy of pure natural honey as prophylaxis against radiochemotherapy-induced mucositis, through clinical scoring of oral and oropharyngeal mucositis, and culturing of pathogenic oral and oropharyngeal microbes.
                The study was done in Assiut University Hospital, Egypt, between January 2005 and July 2006. Forty patients diagnosed with head and neck cancer were entered into the trial. Enrolled patients were randomised to either the treatment group, receiving concomitant chemotherapy and radiotherapy (with a significant area of directly visible oral and/or oropharyngeal mucosa included in the radiation fields) plus prior topical application of pure natural honey, or the control group, receiving concomitant chemotherapy and radiotherapy without honey. Patients were evaluated clinically every week to assess development of radiation mucositis. Aerobic cultures and candida colonisation assessment were undertaken, via oral and oropharyngeal swabs, prior to and at the completion of irradiation, and when infection was evident.
                In the treatment group, no patients developed grade four mucositis and only three patients (15 per cent) developed grade three mucositis. In the control group, 13 patients (65 per cent) developed grade three or four mucositis (p < 0.05). Candida colonisation was found in 15 per cent of the treatment group and 60 per cent of the control group, either during or after radiotherapy (p = 0.003). Positive cultures for aerobic pathogenic bacteria were observed in 15 per cent of the treatment group and 65 per cent of the control group, during or after radiotherapy (p = 0.007).
                This study shows that prophylactic use of pure natural honey was effective in reducing mucositis resulting from radiochemotherapy in patients with head and neck cancer. A randomized control trial study was carried out to evaluate the effect of allopurinol mouth wash on stomatitis induced by chemotherapy in gynecologic patients. Chemotherapeutics used consisted of 5-FU+CDDP (PF) given to 10 patients and vincristine and actinomycin-D+cyclophosphamide (VAC) given to 5. Allopurinol mouth wash was prepared for patients to rinse their mouth with the solution 4-5 times daily before and after treatment with anti-cancer drugs. The Japan Society For Cancer Therapy's criteria for stomatitis were used. In the control group, stomatitis occurred in 9 of the 10 patients receiving PF therapy and in all of the 5 receiving VAC. In contrast, stomatitis was observed in only 2 of the 10 patients receiving PF therapy and 2 of the 5 VAC in the allopurinol-treated group. Allopurinol mouth wash showed a marked effect on stomatitis induced by chemotherapy. The aim of this study was to evaluate the effectiveness of granulocyte-macrophage colony-stimulating factor (GM-CSF) mouthwashes in the prevention of severe mucositis induced by high doses of chemotherapy.
                Ninety consecutive patients affected by solid tumors and undergoing high-dose chemotherapy with autologous peripheral blood stem cell transplantation rescue were randomized to receive placebo versus GM-CSF mouthwash 150 micro g/day. Patients were stratified on the basis of the conditioning treatment and the consequent different risk of severe oral mucositis. Treatment was administered from the day after the end of chemotherapy until the resolution of stomatitis and/or neutrophil recovery.
                The statistical analyses were intention-to-treat and involved all patients who entered the study. The severity of stomatitis was evaluated daily by the physicians according to National Cancer Institute Common Toxicity Criteria. Both study and control groups were compared with respect to the frequency [30% versus 36%, chi(2) exact test, not significant (NS)] and mean duration (4.8 +/- 4.7 versus 4.4 +/- 2.7 days, t-test, NS) of severe stomatitis (grade > or =3). Oral pain was evaluated daily by patients themselves by means of a 10 cm analog visual scale: the mean (+/- standard error of the mean) maximum mucositis scores were 4.8 +/- 3.5 versus 4.2 +/- 3.5 cm (t-test, NS). Furthermore, 15/46 patients in the study group (33%) and 19/44 patients in the control group experienced pain requiring opioids (chi(2) exact test, NS).
                We did not find any evidence to indicate that prophylaxis with GM-CSF mouthwash can help to reduce the severity of mucositis in the setting of the patients we studied.
This review found preliminary data in support of the efficacy of topical calendula for prophylaxis of acute dermatitis during radiotherapy and Traumeel S mouthwash in the treatment of chemotherapy-induced stomatitis. These trials need replicating. There is no convincing evidence for the efficacy of homeopathic medicines for other adverse effects of cancer treatments. Further research is required.