Effects of a Plantago ovata-based herbal compound in prevention and treatment of oral mucositis in patients with breast cancer receiving chemotherapy: A double-blind,randomized, controlled crossover trial |
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| Affiliation: | 1. Herbal and Traditional Medicines Research Center, Kerman University of Medical Sciences, Kerman 7616913555, Iran;2. Department of Traditional Medicine, School of Traditional Medicine, Kerman University of Medical Sciences, Kerman 7618843883, Iran;3. Clinical Immunology Research Center, Ali-ebne Abitaleb Hospital, Zahedan University of Medical Sciences, Zahedan 9816743111, Iran;4. Noncommunicable Diseases Research Center, Fasa University of Medical Sciences, Fasa 7461686688, Iran;5. Medical School, Zahedan University of Medical Sciences, Zahedan 9816743175, Iran;6. Department of Traditional Pharmacy, School of Traditional Medicine, Kerman University of Medical Sciences, Kerman 7618843883, Iran;1. Student Research Committee, Kerman University of Medical Sciences, Kerman, Iran;2. Hematology and Oncology Division, Department of Internal Medicine, Kerman University of Medical Sciences, Kerman, Iran;3. Pharmaceutics Research Center, Neuropharmacology Institute, Kerman University of Medical Sciences, Kerman, Iran;4. Neuroscience Research Center, Neuropharmacology Institute, Kerman University of Medical Sciences, Kerman, Iran;5. Pathology and Stem Cell Research Center, Kerman University of Medical Sciences, Kerman, Iran;6. Department of Public Health, School of Public Health, Jiroft University of Medical Sciences, Jiroft, Iran;7. HIV/STI Surveillance Research Center, and WHO Collaborating Center for HIV Surveillance, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran;1. Cancer Research Center, Mashhad University of Medical Sciences, Mashhad, Iran;2. Department of Clinical Pharmacy, Faculty of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran;3. Pharmaceutical Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran;4. Department of Pharmacodynamics and Toxicology, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran;1. Department of Oral and Maxillofacial Surgery, and Plastic Surgery, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan;2. Department of General Surgical Science, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan;3. Department of Dermatology, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan;1. Community-Based Psychiatric Care Research Center, Department of Medical Surgical Nursing, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran;2. Hematology Research Center, Department of Hematology and Medical Oncology, Shiraz University of Medical Sciences, Shiraz, Iran;1. Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran;2. Taleghani Bone Marrow Transplantation Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran;3. Student Research Committee, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran;4. Pediatric Congenital Hematologic Disorders Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran;5. Department of Pharmacognosy, School of Pharmacy and, Shahid Beheshti University of Medical Sciences, Tehran, Iran;6. Pharmaceutical sciences research center, Shahid Beheshti University of Medical Sciences, Tehran, Iran |
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| Abstract: | BackgroundOral mucositis (OM) is one of the most common complications of mucotoxic cancer therapy. Mucositis induces clinically significant pain, increases the risk of infections and affects the patients’ quality of life.ObjectiveThis study investigated the effects of an herbal preparation from Plantago ovata hydrocolloid in the prevention and treatment of OM, in breast cancer patients undergoing chemotherapy with a regimen including adriamycin.Design, setting, participants, and interventionsThis research was a double-blind, randomized, controlled crossover trial. The herbal compound consisted of a mixture of 500 mg of P. ovate husk in 30 mL water plus three drops of vinegar per dose, which was used as a mouthwash. Phytochemical and physicochemical tests of the compound were also performed. Twenty-eight patients who developed mucositis during the chemotherapy screening cycle were randomized to the herbal compound (n = 14) and placebo (n = 14) groups. They received herbal compound or placebo three times per day during their next chemotherapy cycle (cycle 1 of treatment). Patients were crossed over during cycle 2 of treatment and received the alternative therapy. An oral care protocol was prescribed to all patients in cycles 1 and 2 of the treatment.Main outcome measuresThe patients were visited at baseline, the end of the first and second weeks of the screening cycle, and the end of the first and second weeks of each of two treatment cycles. The degree of mucositis was used as the main treatment outcome. Other indexes, such as the severity of pain, xerostomia grade and the quality of life were also measured.ResultsCompared with the placebo, the herbal compound significantly reduced the degree of mucositis, the severity of pain and the xerostomia grade; it also improved the patients’ quality of life (P < 0.05). Comparison between the screening cycle and placebo treatment group showed that the oral care protocol had a significant effect in the reduction of OM (P < 0.05).ConclusionThe oral care protocol and the herbal compound based on P. ovata are effective ways for preventing and treating OM in patients undergoing mucotoxic cancer therapy.Trial registrationIranian registry of clinical trials IRCT20180923041093N1. |
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| Keywords: | Persian medicine Oral mucositis Breast cancer Chemotherapy |
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