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

NCT02556632 | Completed Phase 2 Results DMC

• 5 other identifiers: URCC14079NCI-2015-00869URCC-14079R21CA178648UG1CA189961
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Breast Carcinoma; Pain; Radiation-Induced Dermatitis; Stage 0 Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (3)

Arm I (curcumin-based gel)

EXPERIMENTAL

Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.

Drug: Curcumin-based Gel; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration

Arm II (HPR Plus)

EXPERIMENTAL

Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.

Procedure: Dermatologic Complications Management; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration

Arm III (placebo gel)

PLACEBO COMPARATOR

Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.

Other: Laboratory Biomarker Analysis; Other: Placebo; Other: Questionnaire Administration

Interventions

Curcumin-based Gel DRUG

Applied topically

Also known as: Curcumin Gel, Psoria-Gold, Topical Curcumin

Arm I (curcumin-based gel)

Dermatologic Complications Management PROCEDURE

Apply HPR Plus topically

Arm II (HPR Plus)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (curcumin-based gel); Arm II (HPR Plus); Arm III (placebo gel)

Placebo OTHER

Apply placebo gel topically

Also known as: placebo therapy, PLCB, sham therapy

Arm III (placebo gel)

Questionnaire Administration OTHER

Ancillary studies

Arm I (curcumin-based gel); Arm II (HPR Plus); Arm III (placebo gel)

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gary Morrow: lead
• National Cancer Institute (NCI): collaborator

Study Sites (6)

Delaware/Christiana Care NCORP

Newark, Delaware, 19713, United States

Location

Heartland NCORP

Decatur, Illinois, 62526, United States

Location

Metro-Minnesota NCORP

Minneapolis, Minnesota, 55426, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Columbus NCORP

Columbus, Ohio, 43215, United States

Location

Dayton Oncology Research Program

Dayton, Ohio, 45420, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Pain; Radiodermatitis; Breast Carcinoma In Situ

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dermatitis; Radiation Injuries; Wounds and Injuries; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Results Point of Contact

• Title: Julie Ryan Wolf, PhD, MPH; Associate Professor of Dermatology and Radiation Oncology
• Organization: University of Rochester

julie_ryan@urmc.rochester.edu

585-276-3862

Study Officials

• Gary Morrow

  University of Rochester NCORP Research Base

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 23, 2015
• First Posted: September 22, 2015
• Study Start: October 13, 2015
• Primary Completion: September 30, 2016
• Study Completion: September 30, 2016
• Last Updated: November 6, 2017
• Results First Posted: November 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)