Malignant diseases of the blood requiring chemotherapy and/or radiation therapy of head and neck MedDRA version: 9.1 Level: LLT Classification code 10066481 Term: Hematological malignancy
Conditions
Interventions
Product Name: bismuth
Pharmaceutical Form: Tablet
CAS Number: 14882189
Other descriptive name: BISMUTH SUBSALICYLATE
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo:
Sponsors
Herlev Hospital, Dept. of haematology (L121)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients of 18 years or over who have been referred to Department of Haematology (L), Herlev Hospital for treatment of haematological malignancies by means of the following regimes: high dose methotrexat, high dose vepesid, high dose melphalan, BEAM, induction treatment by ALL, as well as patients treated with radiation therapy of the oral cavity. Only patients who have signed an informed consent form will be included. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant women and nursing mothers (women of child bearing age must apply secure contraceptive measures) 2. No acceptance from patient 3. Known hypersensitivity to bismuth or other tablet content 4. Severe renal insufficiency with creatinin clearance below 25 ml/min. 5. Patients receiving other treatment for protection of the mucous membrane except cryo treatment of the oral cavity (lumps of ice in the mouth) 6. Other experimental treatment within the previous 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether the administration of bismuth as described in the protocol will prove to have a protective effect on healthy cells. Whether bismuth will counteract the acute (and possibly subacute) side effects that are seen in these patients due to toxicity from chemotherapy and radiation therapy (e.g. stomatitis and enteritis) will be evaluated also.;Secondary Objective: To identify the biological effect(s) of administered bismuth. This will also include the identification of the effect of bismuth on MT regulation and expression in tumour as well as healthy (control) tissue. Other survival/growth factors will be also be shown. Finally, the intracellular incidence of bismuth compared with administered bismuth will be monitored.;Primary end point(s): To evaluate if the administration of bismuth in relation to intensive chemotherapy and radiation therapy will reduce the toxicity of the mucous membrane | — |
Countries
Denmark
Outcome results
None listed