Acidophilus for the Treatment and Prevention of Oral Candidiasis in Patients Undergoing Radiation Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Summa Health System
ClinicalTrials.gov Identifier:
NCT00768794
First received: October 7, 2008
Last updated: May 30, 2013
Last verified: May 2013

October 7, 2008
May 30, 2013
July 2006
March 2010   (final data collection date for primary outcome measure)
To determine if Lactobacillus acidophilus ,Ritzman Natural Health Acidophilus supplements given twice daily during radiation treatments to the head and neck region after the development of oral thrush is an effective treatment for oral candidiasis. [ Time Frame: during duration of treatment of 4 weeks. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00768794 on ClinicalTrials.gov Archive Site
To the response of oral candidiasis treated with Lactobacillus acidophilus ,Ritzman Natural Health Acidophilus supplements and to determine efficacy. [ Time Frame: during duration of treatment of 4 weeks. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Acidophilus for the Treatment and Prevention of Oral Candidiasis in Patients Undergoing Radiation Therapy
A Trial Using Acidophilus for the Treatment and Prevention of Oral Candidiasis in Head and Neck Cancer Patients Undergoing Radiation Therapy

The purpose of this study is to determine the effectiveness of using acidophilus to treat oral candidiasis (thrush) caused by radiation therapy to the head and neck region.

This study will conducted in two parts. In the first part of the study, two participants will begin radiation therapy. When signs and symptoms of thrush are noted, such as smooth, creamy, white/yellow coating and/or patches on the tongue and inside of your mouth that are painful, you will begin taking acidophilus capsules twice each day until the last day of radiation therapy.

The second part of the study is to determine if acidophilus is effective in preventing oral candidiasis (thrush) during radiation therapy to the head and neck region. In the second part of the study three participants will take acidophilus capsules twice each day beginning on the first day of radiation therapy and continuing until the last day of radiation therapy.

To determine if Lactobacillus acidophilus ,Ritzman Natural Health Acidophilus supplements given twice daily during radiation treatments to the head and neck region after the development of oral thrush is an effective treatment for oral candidiasis.

To determine if Lactobacillus acidophilus ,Ritzman Natural Health Acidophilus supplements given twice daily beginning on the first day of radiation treatments to the head and neck region prevents the development of oral thrush.

To assess subjective and objective response of oral candidiasis treated with Lactobacillus acidophilus ,Ritzman Natural Health Acidophilus supplements.

To assess the efficacy of Lactobacillus acidophilus ,Ritzman Natural Health Acidophilus supplements in preventing oral candidiasis in patients receiving radiation therapy to the head and neck region.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Oral Candidiasis
  • Dietary Supplement: Acidophilus

    Use of Acidophilus in the first part of the study, two participants will begin radiation therapy. When signs and symptoms of thrush are noted, such as smooth, creamy, white/yellow coating and/or patches on the tongue and inside of their mouth that are painful, subjects will begin taking acidophilus capsules twice each day until the last day of radiation therapy.

    The second part of the study is to determine if acidophilus is effective in preventing oral candidiasis (thrush) during radiation therapy to the head and neck region.

    Other Name: Acidophilus
  • Dietary Supplement: Acidolphilus
    The second part of the study is to determine if acidophilus is effective in preventing oral candidiasis (thrush) during radiation therapy to the head and neck region.
    Other Name: Acidolphilus
Active Comparator: Acidolphilus
In the first part of the study, two participants will begin radiation therapy. When signs and symptoms of thrush are noted, such as smooth, creamy, white/yellow coating and/or patches on the tongue and inside of their mouth that are painful, subjects will begin taking acidophilus capsules twice each day until the last day of radiation therapy.
Interventions:
  • Dietary Supplement: Acidophilus
  • Dietary Supplement: Acidolphilus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
September 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00768794
Acidophilus
No
Summa Health System
Summa Health System
Not Provided
Principal Investigator: Heather Tharpe, Rn, BSN, OCN Summa Health System
Study Director: Joyce Neading, RHIT, CTR Summa Health System
Summa Health System
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP