Prophylactic Topical Agents in Reducing Radiation-Induced Dermatitis in Patients With Non-inflammatory Breast Cancer



Status:Completed
Conditions:Breast Cancer, Chronic Pain, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery, Musculoskeletal, Oncology
Healthy:No
Age Range:21 - Any
Updated:11/8/2017
Start Date:October 13, 2015
End Date:September 30, 2016

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Effectiveness of Prophylactic Topical Agents for Radiation Dermatitis

This randomized pilot phase II trial studies and compares prophylactic topical agents in
reducing radiation-induced dermatitis in patients with non-inflammatory breast cancer or
breast cancer in situ. The prophylactic topical agents, such as curcumin-based gel or HPR
Plus, may reduce the severity of the radiation-induced dermatitis by minimizing water loss
and inflammation during radiation therapy.

PRIMARY OBJECTIVE:

I. To investigate the effectiveness of Curcumin gel (curcumin-based gel) or HPR Plus™ in
reducing radiation dermatitis in breast cancer patients.

Inclusion Criteria:

- Subjects with a diagnosis of non-inflammatory breast cancer or carcinoma in situ

- Subjects must be prescribed and scheduled for "conventional fractionated" RT without
concurrent chemotherapy; bolus and intensity modulated radiation therapy (IMRT) are
permitted; lymph node irradiation (i.e., internal mammary nodes, supraclavicular
nodes, axillary nodes, etc) as part of their prescribed radiation therapy are
permitted; conventional fractionated radiation therapy regimens eligible for study are
described below:

- Minimal (min) total dose: whole breast: 44 gray (Gy); breast boost: 10 Gy; tumor
bed = whole breast +/- boost: 50.0 Gy; lymph nodes: 45 Gy

- Maximal (max) total dose: whole breast: 50.4 Gy; breast boost: 20 Gy; tumor bed =
whole breast +/- boost: 66.0 Gy; lymph nodes: 50.4 Gy

- Min dose per fraction: whole breast: 1.8 Gy; breast boost: 2.0 Gy; tumor bed =
whole breast +/- boost: 1.8 Gy; lymph nodes: 1.8 Gy

- Max dose per fraction: whole breast: 2.0 Gy; breast boost: 2.0 Gy; tumor bed =
whole breast +/- boost: 2.0 Gy; lymph nodes: 2.0 Gy

- Min # of fractions: whole breast: 22 Gy; breast boost: 5 Gy; tumor bed = whole
breast +/- boost: 25 Gy; lymph nodes: 25 Gy

- Max # of fractions: whole breast: 28 Gy; breast boost: 10 Gy; tumor bed = whole
breast +/- boost: 36 Gy; lymph nodes: 28 Gy

- Min # of sessions: whole breast: 22 Gy; breast boost: 5 Gy; tumor bed = whole
breast +/- boost: 25 Gy; lymph nodes: 25 Gy

- Max # of sessions: whole breast: 28 Gy; breast boost: 10 Gy; tumor bed = whole
breast +/- boost: 36 Gy; lymph nodes: 28 Gy

- Subjects may or may not have had surgery (lumpectomy or mastectomy) prior to RT;
(NOTE: surgery is not required for eligibility)

- Subjects may have had chemotherapy prior to radiation; a minimum of two weeks is
required between end of chemotherapy and start of RT

- Subjects may be currently prescribed hormone treatment or Herceptin therapy

- Subjects must be able to read, speak, and understand English

- Subjects must have the ability to understand and the willingness to sign a written
informed consent document

- Subjects must agree to not use any other topical agents on skin in the radiation
treatment area during the course of this trial; subjects should only use topical
agents for the study (i.e., topical intervention or standard care agents) supplied by
the study personnel and/or treating physician

Exclusion Criteria:

- Pregnant females are ineligible; all subjects of childbearing potential will be asked
if they are pregnant or could be pregnant; the patient must respond "no" to continue
with radiation and to participate in this clinical study

- Subjects with bilateral breast cancer are not eligible

- Subjects receiving the short-course fractionation radiation therapy (i.e., 16 sessions
or 20 sessions at 2.4 to 2.6 Gy fractions per session, with or without boost)

- Subject is currently on anti-EGFR (human epidermal growth factor receptor) therapy,
such as Iressa (gefitinib) or Erbitux (cetuximab, C225)

- Previous radiation to the chest or breast

- Subjects with breast reconstruction prior to RT

- Previous diagnosis of radiosensitivity disorder (i.e., ataxia telangiectasia)

- Previous diagnosis of collagen vascular disorder or vasculitis

- Presence of unhealed surgical wounds in chest or breast region and/or breast infection

- Current daily application of a prescribed topical product to the skin within the RT
area for an unrelated skin condition that cannot be discontinued during the
participation in this clinical trial

- Presence of any active dermatological issues in radiation treatment area (i.e., fungal
skin infection, dermatitis, psoriasis plaques, etc)
We found this trial at
6
sites
Columbus, Ohio 43215
Phone: 614-488-3320
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Julie L. Ryan
Phone: 585-276-3862
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Dayton, Ohio 45420
Phone: 937-775-1350
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Decatur, Illinois 62526
Phone: 217-876-6618
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Minneapolis, Minnesota 55426
Phone: 952-993-1532
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Minneapolis, MN
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Newark, Delaware 19713
Phone: 302-623-4518
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Newark, DE
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