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

Pain Clinical Trial

— Curcumin-II  

Official title:

Effectiveness of Prophylactic Topical Agents for Radiation Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02556632
• Other study ID #: URCC14079
• Secondary ID: NCI-2015-00869UR
• Status: Completed
• Phase: Phase 2
• First received: July 23, 2015
• Last updated: October 4, 2017
• Start date: October 13, 2015
• Est. completion date: September 30, 2016

Study information

• Verified date: October 2017
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

PRIMARY OBJECTIVE:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: September 30, 2016
• Est. primary completion date: September 30, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Carcinoma In Situ
• Breast Neoplasms
• Dermatitis
• Pain
• Radiation-Induced Dermatitis
• Radiodermatitis
• Stage 0 Breast Cancer

Intervention

Drug:
• Curcumin-based Gel
Applied topically

Procedure:
• Dermatologic Complications Management
Apply HPR Plus topically

Other:
• Laboratory Biomarker Analysis
Correlative studies
• Placebo
Apply placebo gel topically
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Columbus NCORP	Columbus	Ohio
United States	Dayton Oncology Research Program	Dayton	Ohio
United States	Heartland NCORP	Decatur	Illinois
United States	Metro-Minnesota NCORP	Minneapolis	Minnesota
United States	Delaware/Christiana Care NCORP	Newark	Delaware
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
Gary Morrow	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Radiation Dermatitis Severity (RDS) Score. Range: 0 (no Dermatitis) - 4 (Violaceous Erythema With Diffuse Desquamation Occurring in Sheets; Patchy Crusting; Superficial Ulceration)	The mean 1 week post-RT RDS score for each arm will be compared using ANOVA to determine if the topical interventions reduce the severity of skin reactions at the end of RT.; The RDS score ranges from 0-4 with higher scores indicating worse outcome.	Baseline up to 1 week post radiation therapy
Primary	Incidence of Moist Desquamation (Present vs. Absent)	The degree to which each topical intervention decreases the incidence of moist desquamation will be examined using Fisher's exact test. Each agent's potential as a preventative intervention will be determined through comparison of the proportion of subjects with no to minimal radiation dermatitis within each arm using Fisher's exact test.	Baseline up to completion of radiation therapy
Primary	Change in the Severity of Skin Reactions Using the Radiation Dermatitis Scale (RDS). Range: 0 (no Dermatitis) - 4 (Violaceous Erythema With Diffuse Desquamation Occurring in Sheets; Patchy Crusting; Superficial Ulceration)	The mean 1 week post-RT RDS score for each arm will be compared using ANOVA to determine if the topical interventions reduce the severity of skin reactions after completion of RT.; The RDS score ranges from 0-4 with higher scores indicating worse outcome.	Baseline to up to 1 week after completion of radiation therapy