Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT00768794
Eligibility Criteria:
Inclusion Criteria:
* Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the head and neck region receiving \> 50 Gy to head and neck tumor with or without concomitant chemotherapy and/or cetuximab.
* Age ≥ 18
* Karnofsky Performance Score of \> 70
* History and physical examination within 8 weeks prior to registration
* Patient must sign study specific informed consent prior to study entry.
Exclusion Criteria:
* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years.
* Patients with carcinoma in-situ of the breast, oral cavity, or cervix are eligible.
* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
* Acute bacterial or fungal infection requiring intravenous or oral antibiotics at study entry
* Sjoren's syndrome
* Hypoadrenalism
* Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol.
* Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
* Prior allergic reaction to Lactobacillus acidophilus.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00768794
Study Brief:
Protocol Section:
NCT00768794