Protocol Number: 09-C-0120

Title:

An Exploratory Evaluation of Biomarkers in Blister Fluid in Healthy Volunteers and Irradiated Skin

Number:

09-C-0120

Summary:

Background:

- Blister fluid contains many of the same biomarkers (substances that can be used to determine the effects of certain kinds of treatments) as blood and urine samples, particularly regarding changes in the skin.

- The Radiation Oncology Branch and others are conducting research studies that require blood and urine samples from healthy volunteers and from patients with cancer. In addition to these samples, researchers would like to collect the fluid from blisters to examine markers of inflammation in the skin.

Objectives:

- To compare blood, urine, and blister fluid samples of patients with cancer who are undergoing radiation therapy to that of volunteers without cancer who will not be receiving radiation therapy.

- To gather more information about the effects of radiation therapy on the skin and body fluids of individuals.

Eligibility:

- Patients 18 years of age and older who will be receiving radiation therapy for either breast or prostate cancer.

- A separate group of healthy volunteers will also participate in this study.

Design:

- Physical examination and blood samples to determine eligibility for the study.

- Blister induction, conducted before the start of radiation treatment, at completion of radiotherapy (last day of treatment), and at a visit 12 months after the end of radiation treatment.

-Blisters will be created through the use of a suction blister device on the hip (for patients with prostate cancer) or on the treated breast or location of removed breast (for patients with breast cancer).

-Blisters will take approximately 30 minutes to form, and fluid will be removed with a needle and syringe.

-Blood and urine samples will also be collected at this time.

- Radiation treatment for breast or prostate cancer will be conducted according to standard procedures, or as directed by a separate research protocol.

- Evaluations during the treatment period:

-Physical examination, including vital signs and body weight checks, and pregnancy test for women who can become pregnant.

-Blood and urine tests.

-Disease evaluation.

- Post-treatment evaluations:

-Clinic visits at months 1, 3, 6, 9, and 12 after the end of radiation therapy for physical examination and disease assessment.

-Study will end 1 year after the final radiation treatment, upon the collection of the final (third) blister fluid sample.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

2.1.1.1 Histological diagnosis: Pathologically confirmed diagnosis of 1) invasive breast cancer, 2) ductal carcinoma in situ, or 3) adenocarcinoma of the prostate.

2.1.1.2 Patients in whom the management of the histologic diagnosis will include radiation treatment as part of standard clinical management.

2.1.1.3 Patients in whom the extent of disease is considered local or locoregional (ie. requiring definitive radiotherapy to the breast or prostate).

2.1.1.4 Patients must be older than 18 years of age.

2.1.1.5 Patients must have a primary medical or surgical oncologist in the community or at NCI who is wiling to collaborate with the ROB staff in the clinical management of the patient.

2.1.1.6 Patients of childbearing or child- fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated with radiotherapy on this study.

2.1.1.7 Patients must have an ECOG performance status of 0-2 and a life expectancy greater than 12 months.

EXCLUSION CRITERIA:

2.1.2.1 Patients with a history of chronic skin disease such as psoriasis, eczema, or history of keloid formation.

2.1.2.2 Patients requiring concurrent use of topical steriods

2.1.2.3 Patients requiring concurrent use of glucocorticoid therapy.

2.1.2.4 Patients who have received topical or systemic chemotherapy within 4 weeks of enrollment (not including hormonal agents such as antiandrogens, GnRH agonists, aromatase inhibitors, tamoxifen, and similar agents) are excluded.

2.1.2.5 Patients requiring concurrent chemotherapy with radiotherapy except as noted in 2.1.2.3 are excluded.

2.1.2.6 Patients with a history of lupus erythematosis, scleroderma, ataxia telengiectasia or other known hypersensitivity to therapeutic radiation.

2.1.2.7 Patients with prior radiotherapy to the site which would be used for blister induction.

2.1.2.8 Patients who are pregnant because of the potential mutagenic effects of radiation on a developing fetus or newborn.

2.1.2.9 Patients with unrelated systemic illness which in the judgment of the Principal Investigator (PI) would compromise the patient's ability to tolerate this therapy or are likely to interfere with the study procedures or results.

2.1.2.10 Patients who are in the estimation of the PI, deemed unable or unlikely to adhere to protocol treatment.

2.1.2.11Patients with significant skin atrophy that would interfere with blister formation.

2.1.2.12Breast cancer patients in whom the site of radiotherapy includes a myocutaneous flap or skin graft.

ELIGIBILITY CRITEREIA FOR HEALTHY VOLUNTEERS:

INCLUSION CRITERIA:

2.2,1.1 Healthy volunteers older than 18 years of age.

2.2.1.2 Ability to provide informed consent.

EXCLUSION CRITERIA:

2.2.2.1 History of chronic skin disease such as psoriasis, eczema, or history of keloid formation.

2.2.2.2 Concurrent use of glucocorticoid therapy.

2.2.2.3 History of lupus erythematosis, scleroderma, ataxia telengiectasia or other known hypersensitivity to therapeutic radiation.

2.2.2.4 Prior radiotherapy to the site which would be used for blister induction (for benign or malignant causes).

2.2.2.5 Unrelated systemic illness which in the judgment of the Principal Investigator (PI) would compromise the patient's ability to tolerate blister induction or are likely to interfere with blister healing, the study procedures, or the study results.

2.2.2.6 Darkly pigmented skin in whom pigmentation changes are a likely complication

2.2.2 7 Significant skin atrophy that would interfere with blister formation.

Special Instructions:

Currently Not Provided

Keywords:

Radiation

Blister

Healthy Volunteer

Samples

Recruitment Keyword(s):

Radiation

Prostate Cancer

Breast Cancer

Healthy Volunteer

HV

Condition(s):

Breast Cancer

Healthy Volunteer

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):

Thames HD, Bentzen SM, Turesson I, Overgaard M, Van den Bogaert W. Time-dose factors in radiotherapy: a review of the human data. Radiother Oncol. 1990 Nov;19(3):219-35.

Hopewell JW. Mechanisms of the action of radiation on skin and underlying tissues. Br J Radiol Suppl. 1986;19:39-47.

Emami B, Lyman J, Brown A, Coia L, Goitein M, Munzenrider JE, Shank B, Solin LJ, Wesson M. Tolerance of normal tissue to therapeutic irradiation. Int J Radiat Oncol Biol Phys. 1991 May 15;21(1):109-22.

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