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

NCT00768794 | Completed

• 1 other identifier: Acidophilus
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Candidiasis

Keywords

thrush

Outcome Measures

Primary Outcomes (1)

• 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.

  during duration of treatment of 4 weeks.

Secondary Outcomes (1)

• To the response of oral candidiasis treated with Lactobacillus acidophilus ,Ritzman Natural Health Acidophilus supplements and to determine efficacy.

  during duration of treatment of 4 weeks.

Study Arms (1)

Acidolphilus

ACTIVE COMPARATOR

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.

Dietary Supplement: Acidophilus; Dietary Supplement: Acidolphilus

Interventions

Acidophilus DIETARY_SUPPLEMENT

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.

Acidolphilus

Acidolphilus DIETARY_SUPPLEMENT

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.

Acidolphilus

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Summa Health System: lead

Study Sites (1)

Summa Health System

Akron, Ohio, 44304, United States

Location

MeSH Terms

Conditions

Candidiasis, Oral

Interventions

Lacteol

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Heather Tharpe, Rn, BSN, OCN

  Summa Health System

  PRINCIPAL INVESTIGATOR

• Joyce Neading, RHIT, CTR

  Summa Health System

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2008
• First Posted: October 8, 2008
• Study Start: July 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: September 1, 2010
• Last Updated: May 31, 2013

Record last verified: 2013-05

Locations

US (1)