Prophylactic Topical Agents in Reducing Radiation-Induced Dermatitis in Patients With Non-inflammatory Breast Cancer (Curcumin-II)

• ClinicalTrials.gov Identifier: NCT02556632
• Recruitment Status: Completed
• First Posted: September 22, 2015
• Results First Posted: November 6, 2017
• Last Update Posted: November 6, 2017
• Sponsor: Gary Morrow
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Gary Morrow, University of Rochester NCORP Research Base

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Carcinoma; Pain; Radiation-Induced Dermatitis; Stage 0 Breast Cancer	Drug: Curcumin-based Gel; Procedure: Dermatologic Complications Management; Other: Laboratory Biomarker Analysis; Other: Placebo; Other: Questionnaire Administration	Phase 2

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 191 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Effectiveness of Prophylactic Topical Agents for Radiation Dermatitis
• Actual Study Start Date: October 13, 2015
• Actual Primary Completion Date: September 30, 2016
• Actual Study Completion Date: September 30, 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm I (curcumin-based gel); 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; Applied topically; Other Names: Curcumin Gel; Psoria-Gold; Topical Curcumin; Other: Laboratory Biomarker Analysis; Correlative studies; Other: Questionnaire Administration; Ancillary studies
Experimental: Arm II (HPR Plus); 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; Apply HPR Plus topically; Other: Laboratory Biomarker Analysis; Correlative studies; Other: Questionnaire Administration; Ancillary studies
Placebo Comparator: Arm III (placebo gel); 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; Correlative studies; Other: Placebo; Apply placebo gel topically; Other Names: placebo therapy; PLCB; sham therapy; Other: Questionnaire Administration; Ancillary studies

Outcome Measures

Primary Outcome Measures :

1. Mean Radiation Dermatitis Severity (RDS) Score. Range: 0 (no Dermatitis) - 4 (Violaceous Erythema With Diffuse Desquamation Occurring in Sheets; Patchy Crusting; Superficial Ulceration) [ Time Frame: Baseline up to 1 week post radiation therapy ]

   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.

2. Incidence of Moist Desquamation (Present vs. Absent) [ Time Frame: Baseline up to completion of radiation therapy ]
   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.
3. 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) [ Time Frame: Baseline to up to 1 week after completion of radiation therapy ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Locations

United States, Delaware

Delaware/Christiana Care NCORP

Newark, Delaware, United States, 19713

United States, Illinois

Heartland NCORP

Decatur, Illinois, United States, 62526

United States, Minnesota

Metro-Minnesota NCORP

Minneapolis, Minnesota, United States, 55426

United States, New York

University of Rochester

Rochester, New York, United States, 14642

United States, Ohio

Columbus NCORP

Columbus, Ohio, United States, 43215

Dayton Oncology Research Program

Dayton, Ohio, United States, 45420

Sponsors and Collaborators

Gary Morrow

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Gary Morrow; University of Rochester NCORP Research Base

More Information

• Responsible Party: Gary Morrow, Director, University of Rochester NCORP Research Base
• ClinicalTrials.gov Identifier: NCT02556632 History of Changes
• Other Study ID Numbers: URCC14079; NCI-2015-00869 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); URCC14079 ( Other Identifier: University of Rochester NCORP Research Base ); URCC-14079 ( Other Identifier: DCP ); R21CA178648 ( U.S. NIH Grant/Contract ); UG1CA189961 ( U.S. NIH Grant/Contract )
• First Posted: September 22, 2015
• Results First Posted: November 6, 2017
• Last Update Posted: November 6, 2017
• Last Verified: October 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Breast Neoplasms; Breast Carcinoma In Situ; Dermatitis; Radiodermatitis; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Radiation Injuries; Wounds and Injuries; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Curcumin; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action