Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02575313
Other study ID # 07-173B
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received September 25, 2015
Last updated October 9, 2015
Start date October 2009
Est. completion date September 2012

Study information

Verified date October 2015
Source Providence Health & Services
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This is a study to see if a Whole Food Intervention (WFI) consisting of yogurt, butter, honey, vanilla, and glutamine will lower the frequency or severity of mucositis in head and neck cancer patients undergoing standard treatment.


Description:

The proposal is a one center, open label, randomized pilot study to evaluate the safety, tolerability and compliance of a Whole Food Intervention with Standard of Care for patients with head & neck cancer. The primary objectives are:

1. To determine whether patients will use a Whole Food Intervention 4-6 times daily, and

2. To determine whether the Whole Food Intervention will reduce the incidence of grade 2 or greater mucositis from 75% historically seen to 25% .

3. To determine whether Whole Food Intervention will reduce the incidence of treatment breaks from >19% to < 10% (see section 9 for comments)

This Whole Food Intervention will be taken by mouth before the start of radiation therapy, with or without chemotherapy and for the entire treatment therapy.

Mucositis-related pain and reduction of oral intake will be quantified by using validated assessment tools. Weight loss or gain, diarrhea, constipation or no change in bowel function and the use of conventional medication for radiation-induced mucositis will be recorded. Chart review and patient questionnaires will be used to establish whether a treatment break or dose reduction for radiation of chemotherapy was required due to radiation mucositis-related symptoms. Complete Chemistry Profile and Complete Blood Count will be extracted from the patients' medical oncologist's or radiation oncologist's records. The patient will continue to use standard mucositis therapies if desired as prescribed by the treating oncology physician.

The Whole Food Intervention consists of yogurt, butter, honey, vanilla, and glutamine with 3 portioning cups, equal to approximately 12 ounces, taken daily before starting radiation therapy. A questionnaire will be used to record symptoms and doses taken. The patient will continue to use standard mucositis therapies as prescribed by the treating oncology physician.


Recruitment information / eligibility

Status Terminated
Enrollment 10
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Histopathologically confirmed diagnosis of head & neck carcinoma

- Scheduled to undergo continuous daily course of radiation therapy with or without chemotherapy

- No other serious concurrent medical illness as determined by the Principle Investigator

- Absolute neutrophil count = 500/mm3

- Platelet count = 50,000/mm3

- No history of insulin-dependent diabetes mellitus

- No prior hypersensitivity reaction to compound components

Exclusion Criteria:

- Dislike of the available forms of the WFI

- Allergy or food intolerance relevant to the ingredients

- Lack of access to refrigerated storage for the WFI

- Inability or unwillingness to participate twice a week

- Inability to swallow

- Undergoing treatment for HIV with HIV medications

- Ongoing alcohol and/or drug abuse

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Whole Food Intervention
A combination of honey, glutamine, probiotics, and butter was administered to participants undergoing cancer.

Locations

Country Name City State
United States Integrative Medicine Program, Providence St. Vincent Medical Center Portland Oregon
United States The Oregon Clinic, Providence Portland Cancer Center Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
Providence Health & Services

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of Tolerability Estimated portion consumption on a daily basis was obtained to determine if the WFI could be tolerated by participants. Eight (8) weeks No
Secondary Mucositis Grading Mucositis grade was calculated using established criteria. Eight (8) weeks No
Secondary Treatment Break Measurement To determine whether Whole Food Intervention will reduce the incidence of treatment breaks from =19% to =10%. Eight (8) weeks No
See also
  Status Clinical Trial Phase
Completed NCT02252926 - Local Anesthetic Treatment of Oral Pain in Patients With Mucositis Phase 2
Completed NCT01155609 - L-lysine in Treating Oral Mucositis in Patients Undergoing Radiation Therapy With or Without Chemotherapy For Head and Neck Cancer N/A
Completed NCT00357942 - Topical Morphine for Stomatitis-related Pain Induced by Chemotherapy Phase 4
Completed NCT00360685 - Tacrolimus and Mycophenolate Mofetil (MMF) in GVHD Prophylactic Regimen Compared to Tacrolimus and Methotrexate (MTX N/A
Completed NCT04586491 - The Effect of Oral Care Protocol on Prevention of Oral Mucositis in Pediatric Cancer Patients N/A
Withdrawn NCT02589860 - Analysis of Oral Mucositis in Patient's Undergoing Melphalan Conditioning and Autologous Stem Cell Transplant
Not yet recruiting NCT02506231 - The Effect of Folinic Acid Rescue Following MTX GVHD Prophylaxis on Regimen Related Toxicity and Transplantation Outcome Phase 2/Phase 3
Completed NCT02605382 - Efficacy of 0.12% Chlorhexidine Gluconate for Peri-implant Mucositis Phase 2
Completed NCT02639377 - Efficacy of 0.12% Chlorhexidine Gluconate for Peri-implant Mucositis and Gingivitis Phase 2
Completed NCT00956254 - Fentanyl Sublingual Spray in Treating Opioid-tolerant Cancer Patients With or Without Oral Mucositis Phase 3
Completed NCT00584597 - A Trial of Homeopathic Medication TRAUMEEL S for the Treatment of Radiation-Induced Mucositis Phase 1
Enrolling by invitation NCT05590117 - Protective Effect of Pentoxifylline Against Chemotherapy Induced Toxicities in Patients With Colorectal Cancer Early Phase 1
Completed NCT05635929 - Oral Mucositis and Quality of Life With a Mucosa Topical Composition in Head & Neck Cancer Patients. N/A
Completed NCT05181943 - Effectiveness of Photo-biomodulation in the Treatment of Chemotherapy Induced Mucositis N/A
Completed NCT03713567 - Clinical, Immunological and Microbiological Evaluation of Experimental Gingivitis and Peri-implant Mucositis N/A
Completed NCT02671812 - Outcome After Dental Implant Treatment
Terminated NCT02273752 - Pharmacokinetically Guided Everolimus in Patients With Breast Cancer, Pancreatic Neuroendocrine Tumors, or Kidney Cancer Phase 2
Recruiting NCT01707641 - Effect of Lactobacillus Brevis CD2 in Prevention of Radio-chemotherapy Induced Oral Mucositis in Head and Neck Cancer Phase 4
Completed NCT01015183 - Prevention Chemotherapy Induced Mucositis by Zinc Sulfate Phase 2/Phase 3
Completed NCT00533078 - Lipid Use, Nutrition, and Colitis in Patients With Hematological Malignancies Phase 2