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A double-blind, placebo-controlled, randomized trial to evaluate the role of tetrachlorodecaoxide in the management of chemotherapy-induced oral mucositis.

Abstract

We conducted a double-blind, placebo-controlled, randomized trial to evaluate the efficacy and safety of tetrachlorodecaoxide (TCDO) in patients with chemotherapy-induced mucositis. Sixty-two patients with World Health Organization grade II-IV oral mucositis were eligible for the study. They were randomized to receive TCDO or placebo, 10 ml, twice daily, swish and swallow, for 7 days. Patients were evaluated for oral pain, dysphagia, and oral intake. Downgrading and total duration of mucositis were documented. Thirty-two were randomized to receive TCDO. Thirty received the placebo. All were evaluable. Both arms were well matched for age, gender, type of underlying neoplasm, and prior history of oral mucositis. Intensity of initial symptoms, degree of mucositis, and time period between delivery of chemotherapy and development of mucositis were also similar. Post-therapy evaluation revealed no significant difference in the mean grade of oral and esophageal pain, or dysphagia between TCDO and placebo. Downgrading or total duration of mucositis did not differ between the two groups. Oral intake improved significantly in patients taking TCDO. Time to subjective improvement in oral pain was significantly shorter with TCDO (3.1 versus 3.6 days). Evaluation on day 3 revealed that 77% of those receiving TCDO were free of oral pain in comparison to 46% receiving placebo (P = 0.05). These results indicate that TCDO may be helpful in palliating some of the symptoms related to oral mucositis. The therapeutic benefit, however, is small and needs to be confirmed in a larger trial.

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  • Authors+Show Affiliations

    ,

    Division of Medical Oncology, National Cancer Institute, Clifton, Karachi, Pakistan.

    , ,

    Source

    MeSH

    Adult
    Antineoplastic Agents
    Chlorine
    Double-Blind Method
    Female
    Humans
    Male
    Middle Aged
    Mouth Mucosa
    Oxides
    Placebos
    Stomatitis

    Pub Type(s)

    Clinical Trial
    Journal Article
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    9262037

    Citation

    Malik, I A., et al. "A Double-blind, Placebo-controlled, Randomized Trial to Evaluate the Role of Tetrachlorodecaoxide in the Management of Chemotherapy-induced Oral Mucositis." Journal of Pain and Symptom Management, vol. 14, no. 2, 1997, pp. 82-7.
    Malik IA, Moid I, Haq S, et al. A double-blind, placebo-controlled, randomized trial to evaluate the role of tetrachlorodecaoxide in the management of chemotherapy-induced oral mucositis. J Pain Symptom Manage. 1997;14(2):82-7.
    Malik, I. A., Moid, I., Haq, S., & Sabih, M. (1997). A double-blind, placebo-controlled, randomized trial to evaluate the role of tetrachlorodecaoxide in the management of chemotherapy-induced oral mucositis. Journal of Pain and Symptom Management, 14(2), pp. 82-7.
    Malik IA, et al. A Double-blind, Placebo-controlled, Randomized Trial to Evaluate the Role of Tetrachlorodecaoxide in the Management of Chemotherapy-induced Oral Mucositis. J Pain Symptom Manage. 1997;14(2):82-7. PubMed PMID: 9262037.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - A double-blind, placebo-controlled, randomized trial to evaluate the role of tetrachlorodecaoxide in the management of chemotherapy-induced oral mucositis. AU - Malik,I A, AU - Moid,I, AU - Haq,S, AU - Sabih,M, PY - 1997/8/1/pubmed PY - 1997/8/1/medline PY - 1997/8/1/entrez SP - 82 EP - 7 JF - Journal of pain and symptom management JO - J Pain Symptom Manage VL - 14 IS - 2 N2 - We conducted a double-blind, placebo-controlled, randomized trial to evaluate the efficacy and safety of tetrachlorodecaoxide (TCDO) in patients with chemotherapy-induced mucositis. Sixty-two patients with World Health Organization grade II-IV oral mucositis were eligible for the study. They were randomized to receive TCDO or placebo, 10 ml, twice daily, swish and swallow, for 7 days. Patients were evaluated for oral pain, dysphagia, and oral intake. Downgrading and total duration of mucositis were documented. Thirty-two were randomized to receive TCDO. Thirty received the placebo. All were evaluable. Both arms were well matched for age, gender, type of underlying neoplasm, and prior history of oral mucositis. Intensity of initial symptoms, degree of mucositis, and time period between delivery of chemotherapy and development of mucositis were also similar. Post-therapy evaluation revealed no significant difference in the mean grade of oral and esophageal pain, or dysphagia between TCDO and placebo. Downgrading or total duration of mucositis did not differ between the two groups. Oral intake improved significantly in patients taking TCDO. Time to subjective improvement in oral pain was significantly shorter with TCDO (3.1 versus 3.6 days). Evaluation on day 3 revealed that 77% of those receiving TCDO were free of oral pain in comparison to 46% receiving placebo (P = 0.05). These results indicate that TCDO may be helpful in palliating some of the symptoms related to oral mucositis. The therapeutic benefit, however, is small and needs to be confirmed in a larger trial. SN - 0885-3924 UR - https://www.unboundmedicine.com/medline/citation/9262037/A_double_blind_placebo_controlled_randomized_trial_to_evaluate_the_role_of_tetrachlorodecaoxide_in_the_management_of_chemotherapy_induced_oral_mucositis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0885-3924(97)00018-3 DB - PRIME DP - Unbound Medicine ER -