Breast CarcinomaPhase 2Curcumin-IINCT02556632

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

A Phase 2 study testing Curcumin-based Gel, Dermatologic Complications Management and Laboratory Biomarker Analysis in people with Breast Carcinoma and Pain, run by Gary Morrow at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 years and older, women only
Conditions the study is for: Breast Carcinoma, Pain, Radiation-Induced Dermatitis
What is being tested?: Curcumin-based Gel, Dermatologic Complications Management and Laboratory Biomarker Analysis
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 191 participants
Where: 6 sitesUnited States
Study dates: 13 Oct 2015to 30 Sep 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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

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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)

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Columbus NCORP
Columbus, Ohio, 43215
Dayton Oncology Research Program
Dayton, Ohio, 45420
Heartland NCORP
Decatur, Illinois, 62526
Metro-Minnesota NCORP
Minneapolis, Minnesota, 55426
Delaware/Christiana Care NCORP
Newark, Delaware, 19713
University of Rochester
Rochester, New York, 14642

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVE:

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

Conditions: Breast Carcinoma, Pain, Radiation-Induced Dermatitis, Stage 0 Breast Cancer
Being tested: Curcumin-based Gel, Dermatologic Complications Management, Laboratory Biomarker Analysis, Placebo, Questionnaire Administration
Medical subject headings: Breast Neoplasms, Pain, Radiodermatitis, Breast Carcinoma In Situ

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Curcumin-based GelDrug
Also called Curcumin Gel, Psoria-Gold, Topical Curcumin
Applied topically
Dermatologic Complications ManagementProcedure or surgery
Apply HPR Plus topically
Laboratory Biomarker AnalysisOther
Correlative studies
PlaceboOther
Also called placebo therapy, PLCB, sham therapy
Apply placebo gel topically
Questionnaire AdministrationOther
Ancillary studies

Study groups in NCT02556632
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Other: Laboratory Biomarker Analysis; Other: Placebo; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Baseline to up to 1 week after completion of radiation therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Oct 201530 Sep 2016

First posted22 Sep 2015 (estimated)
Study start13 Oct 2015
Primary completion30 Sep 2016
Study completion30 Sep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 191 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02556632
Sponsor's protocol ID: URCC14079
Other IDs: NCI-2015-00869, URCC14079, URCC-14079, R21CA178648, UG1CA189961
Acronym: Curcumin-II
Status last verified: Oct 2017
First submitted: 23 Jul 2015
Last updated: 6 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Prophylactic Topical Agents for Radiation Dermatitis
ClinicalTrials.gov ID: NCT02556632
Acronym / sponsor ID: Curcumin-II / URCC14079
Conditions: Breast Carcinoma, Pain, Radiation-Induced Dermatitis, Stage 0 Breast Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 191 participants (actual)
Lead sponsor: Gary MorrowUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 13 Oct 2015 (actual)
Primary completion: 30 Sep 2016 (actual)
Study completion: 30 Sep 2016 (actual)
First posted: 22 Sep 2015 (estimated)
Results: Posted 6 Nov 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVE:

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

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Arm I (curcumin-based gel)	Experimental	Drug: Curcumin-based Gel, Other: Laboratory Biomarker Analysis, Other: Questionnaire AdministrationPatients 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.
Arm II (HPR Plus)	Experimental	Procedure: Dermatologic Complications Management, Other: Laboratory Biomarker Analysis, Other: Questionnaire AdministrationPatients 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.
Arm III (placebo gel)	Placebo comparator	Other: Laboratory Biomarker Analysis, Other: Placebo, Other: Questionnaire AdministrationPatients 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.

Who may qualify

Ages: 21 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

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:
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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Curcumin-based GelAlso: Curcumin Gel, Psoria-Gold, Topical CurcuminApplied topically	Drug	Arm I (curcumin-based gel)
Dermatologic Complications ManagementApply HPR Plus topically	Procedure or surgery	Arm II (HPR Plus)
Laboratory Biomarker AnalysisCorrelative studies	Other	Arm I (curcumin-based gel), Arm II (HPR Plus), Arm III (placebo gel)
PlaceboAlso: placebo therapy, PLCB, sham therapyApply placebo gel topically	Other	Arm III (placebo gel)
Questionnaire AdministrationAncillary studies	Other	Arm I (curcumin-based gel), Arm II (HPR Plus), Arm III (placebo gel)

Primary outcome

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.
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.
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.

Results and safety

Results posted to the registry on 6 Nov 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm I (Curcumin-based Gel)	64	59
Arm II (HPR Plus)	65	59
Arm III (Placebo Gel)	62	53

Primary outcome: 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. Mean (Standard Deviation). Unit: units on a scale

Measure	Arm I (Curcumin-based Gel) n = 59	Arm II (HPR Plus) n = 59	Arm III (Placebo Gel) n = 53
Value	2.68 (0.74)	2.64 (0.74)	2.63 (0.69)

Arm I (Curcumin-based Gel) vs Arm II (HPR Plus) vs Arm III (Placebo Gel): p = 0.9306, ANOVA

Population analysed: Note: Of the 64 who were randomized to Arm 1, 59 completed the study; of the 65 who were randomized to Arm II, 59 completed the study; of the 62 who were randomized to Arm III, 53 completed the study

Primary outcome: Incidence of Moist Desquamation (Present vs. Absent)

Time frame: Baseline up to completion of radiation therapy. Count of participants. Unit: Participants

Measure	Arm I (Curcumin-based Gel) n = 59	Arm II (HPR Plus) n = 59	Arm III (Placebo Gel) n = 53
No Moist Desquamation	44	47	41
Moist Desquamation	15	12	12

Arm I (Curcumin-based Gel) vs Arm II (HPR Plus) vs Arm III (Placebo Gel): p = 0.8048, Fisher Exact

Primary outcome: 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. Mean (Standard Deviation). Unit: units on a scale

Measure	Arm I (Curcumin-based Gel) n = 60	Arm II (HPR Plus) n = 58	Arm III (Placebo Gel) n = 52
Value	2.25 (0.99)	2.16 (0.92)	2.15 (0.96)

Arm I (Curcumin-based Gel) vs Arm II (HPR Plus) vs Arm III (Placebo Gel): p = 0.8591, ANOVA

Population analysed: Note: Of the 64 who were randomized to Arm 1, 60 completed 1-week post; of the 65 who were randomized to Arm II, 58 completed 1-week post; of the 62 who were randomized to Arm III, 52 completed 1-week post.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm I (Curcumin-based Gel)	3 of 64 (4.7%)	8 of 64 (12.5%)	0 of 64
Arm II (HPR Plus)	2 of 65 (3.1%)	3 of 65 (4.6%)	1 of 65
Arm III (Placebo Gel)	6 of 62 (9.7%)	5 of 62 (8.1%)	0 of 62

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gary Morrow principal investigator

University of Rochester NCORP Research Base

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02556632.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.