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Breast CancerNCT04190381

A Study to Evaluate the Safety and Clinical Outcome of Using FR-Mask in Breast Cancer Patients With Radiation-irritated Skin After Radiotherapy

A study testing FR-Mask in people with Breast Cancer, run by China Medical University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The breast radiotherapy after breast-conserving surgery reduces the risk of recurrence and death and is widely used for standard treatment for breast cancer. However, radiation dermatitis is a major adverse event of breast radiotherapy. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Breast Cancer
What is being tested?
FR-Mask
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteTaiwan
Study dates
6 Sep 2019to Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must be males or non-pregnant females at least 20 years of age.
  • Diagnosis of, non-inflammatory breast adenocarcinoma or in situ breast cancer and completed post-operative radiotherapy without concurrent chemotherapy.
  • Breast adenocarcinoma previously treated by unilateral lumpectomy with or without adjuvant or neoadjuvant chemotherapy or hormonal treatment.
  • Patients were scheduled to receive at least three sessions of radiotherapy per week (1 session per day) for at least five weeks using standard irradiation fraction (with at least 1.8 Gy per session) for total dose of at least 45 Gy.
  • A time period of at least two weeks after radiotherapy before beginning the study.
  • Participant must give informed consent.

Who cannot join

  • Bilateral breast cancer
  • Previous radiotherapy to the chest
  • Chemotherapy concurrent with radiation treatment
  • Prior breast reconstructions, implants, and/or expanders
  • Known radiosensitivity syndromes (e.g. Ataxia-telangiectasia)
  • Collagen vascular disease, vasculitis, unhealed surgical sites, breast infections or systemic lupus erythematosus (SLE)
  • Participation in any clinical trial in the prior 30 days from baseline.
  • Any condition that, in the judgement of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.

Trial locations and contacts

1 site in 1 country.

Ying-Chun Lin contact

0975682364

D13464@mail.cmuh.org.tw

Taiwan1 site, 1 recruiting

  • China Medical University Hospital

    Taichung

    Ying-Chun Lin, 0975682364, D13464@mail.cmuh.org.tw

    Recruiting

Other trials in Taiwan

About this study

Official title: A Single-arm, Open Label, Single Center Study to Evaluate the Safety and Clinical Outcome of Using FR-Mask in Breast Cancer Patients With Radiation-irritated Skin After Radiotherapy

The breast radiotherapy after breast-conserving surgery reduces the risk of recurrence and death and is widely used for standard treatment for breast cancer. However, radiation dermatitis is a major adverse event of breast radiotherapy. Radiation-irritated skin is a treatment-induced symptom caused by radiation dose-limiting toxicity. It damages skin structure and causes a variety of symptoms of cuticle thinning, sweat glands damage, sebaceous glands damage and basal membrane damage. Radiation-irritated skin also leads to lost work productivity, wound care costs, social isolation and altered body image. Thus, radiation-irritated skin can greatly impact the quality of life.

Several studies have examined the effects of numerous topical agents to reduce the dryness of skin. However, the reported results have not been clinically significant. Previous studies have shown that deer antler velvet extract possess inflammatory function and repair damaged follicles, sweat glands and sebaceous gland. And biocellulose membrane is a highly efficient media to introduce velvet extract to damaged skin tissue.

Read more

In this study, velvet extract combined with biocellolose membrane will be used in breast cancer patients to test the safety and efficacy to alleviate their radiation-irritated skin symptoms.

The investigational medical product of this study is a biomedical repair mask, FR-MASK ;the formula of FR-Mask is deer antler velvet, which is a traditional Chinese tonic medicine combined with high-adhesion biocellulose membrane.

The primary objective of this study is to test the safety and clinical outcomes of FR-Mask application in breast cancer patients who have radiation-irritated skin due to the post-operative radiotherapy.

Conditions
Breast Cancer
Being tested
FR-Mask
Keywords
deer antler velvet, radiation-irritated skin
Medical subject headings
Breast Neoplasms

What participants receive

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

  • FR-MaskOther

    The investigational medical product of this study is a biomedical repair mask, FR-MASK, acting like moisturizing lotion applied on breasts.

    The FR-Mask is applied to users' radiation-irritated breast skin for 15 to 20 minutes every 3 days.

Study groups in NCT04190381
Study groupRoleWhat they receive
FR-Mask applicationExperimentalNot described
Receives: Other: FR-Mask

What is being measured

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

  1. The change of scores of study questionnaire between baseline and each time point used to evaluate the breast cosmetic domain and specific breast pain domain.

    Breast Cancer Treatment Outcome: Scale 1 = no difference between treated and untreated breast and area; 2 = slight difference between treated and untreated breast and area; 3 = moderate difference between treated and untreated breast and area; 4 = large difference between treated and untreated breast and area

    Measured: Treatment: Day1, Day29, Day 57, Day85 and Post-treatment: 1 month

Secondary outcomes (4)

  1. The change of moisture(water) percentage between baseline and each time point measured by skin analyzer (skin observed system) and skin checker (by electrical conductivity).

    Measured: Treatment: Day1, Day29, Day 57, Day85 and Post-treatment: 1 month

  2. The change of oil percentage between baseline and each time point measured by skin analyzer (skin observed system) and skin checker (by electrical conductivity).

    Measured: Treatment: Day1, Day29, Day 57, Day85 and Post-treatment: 1 month

  3. The change of pigment percentage between baseline and each time point measured by skin analyzer (skin observed system).

    Measured: Treatment: Day1, Day29, Day 57, Day85 and Post-treatment: 1 month

  4. The change of sensitivity percentage between baseline and each time point measured by skin analyzer (skin observed system).

    Measured: Treatment: Day1, Day29, Day 57, Day85 and Post-treatment: 1 month

Timeline

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

  1. First posted9 Dec 2019
  2. Study start6 Sep 2019
  3. Primary completionJul 2020 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

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 N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04190381
Sponsor's protocol ID
CMUH108-REC3-090
Status last verified
Dec 2019
First submitted
18 Nov 2019
Last updated
9 Dec 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Chen X, Wang Y, Wu Y, Wang L, Li W. [Protective effects of peptides from velvet antler of Cervus nippon on acute ischemic myocardial injury in rats]. Zhongguo Zhong Yao Za Zhi. 2009 Aug;34(15):1971-4. Chinese.

    PubMed 19894547

  • Suh JS, Eun JS, So JN, Seo JT, Jhon GJ. Phagocytic activity of ethyl alcohol fraction of deer antler in murine peritoneal macrophage. Biol Pharm Bull. 1999 Sep;22(9):932-5. doi: 10.1248/bpb.22.932.

    PubMed 10513615

  • Kim KS, Choi YH, Kim KH, Lee YC, Kim CH, Moon SH, Kang SG, Park YG. Protective and anti-arthritic effects of deer antler aqua-acupuncture (DAA), inhibiting dihydroorotate dehydrogenase, on phosphate ions-mediated chondrocyte apoptosis and rat collagen-induced arthritis. Int Immunopharmacol. 2004 Jul;4(7):963-73. doi: 10.1016/j.intimp.2004.04.010.

    PubMed 15182735

  • Fraser A, Haines SR, Stuart EC, Scandlyn MJ, Alexander A, Somers-Edgar TJ, Rosengren RJ. Deer velvet supplementation decreases the grade and metastasis of azoxymethane-induced colon cancer in the male rat. Food Chem Toxicol. 2010 May;48(5):1288-92. doi: 10.1016/j.fct.2010.02.024. Epub 2010 Feb 20.

    PubMed 20176070

  • Kuo CY, Wang T, Dai TY, Wang CH, Chen KN, Chen YP, Chen MJ. Effect of the Velvet Antler of Formosan Sambar Deer (Cervus unicolor swinhoei) on the Prevention of an Allergic Airway Response in Mice. Evid Based Complement Alternat Med. 2012;2012:481318. doi: 10.1155/2012/481318. Epub 2012 Dec 23.

    PubMed 23346203

Questions about this trial

What is this clinical trial studying?

A study testing FR-Mask in people with Breast Cancer, run by China Medical University Hospital at 1 site in Taiwan.

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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

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

Contact Ying-Chun Lin (0975682364, D13464@mail.cmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change of scores of study questionnaire between baseline and each time point used to evaluate the breast cosmetic domain and specific breast pain domain. (time frame: Treatment: Day1, Day29, Day 57, Day85 and Post-treatment: 1 month). 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 NCT04190381, which also lists 5 linked publications.

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 9 Dec 2019.

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