NCT04650256

Brief Summary

The purpose of this research is to study a Chinese herbal Complementary and Alternative Medicine (CAM) product for the temporary relief of pain and itching after radiotherapy (RT). This is an over-the-counter product with 1% menthol as an active ingredient.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Jul 2021Dec 2027

First Submitted

Initial submission to the registry

November 24, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 2, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

6.5 years

First QC Date

November 24, 2020

Last Update Submit

March 23, 2026

Conditions

Skin Toxicity

Keywords

Breast cancerRadiotherapyComplementary and alternative medicine

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients free of clinically relevant skin toxicities

    Clinically relevant skin toxicities - Grade 2 with moist desquamation or Grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) as evaluated by the treating clinician.

    Up to 18 weeks.

Secondary Outcomes (3)

  • SD-16 scores

    Up to 18 weeks.

  • Functional Assessment of Cancer Therapy-Breast (FACT-B) scores

    Up to 18 weeks.

  • High-sensitivity C-reactive protein (hsCRP) values

    Up to 6 weeks

Study Arms (1)

CAM arm

EXPERIMENTAL

Participants will be given the CAM intervention during scheduled, standard of care radiotherapy (up to 6 weeks) and 8-12 weeks (weeks 14-18) after radiotherapy.

Other: Complementary and alternative medicine (CAM)

Interventions

Complementary and alternative medicine (CAM)OTHER

CAM will be applied topically on the chest wall once during the day (or immediately after radiotherapy) and once at night daily.

CAM arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female subjects with newly diagnosed breast carcinoma
  • \> 18 years of age
  • Post-mastectomy with or without reconstruction
  • Stage II-IIIb with any receptor status
  • All races and ethnicities are eligible
  • Patients must be able to consent in English or Spanish
  • Plan to receive adjuvant radiotherapy to the chest wall +/- regional lymph nodes
  • RT will involve standard fractionation use of 3D conformal or Intensity-modulated RT (IMRT)
  • Willing to sign protocol consent form
  • Patients are allowed to receive adjuvant hormonal therapy and/or targeted therapies such as trastuzumab prior to, during and/or after radiation therapy.
  • Patients may receive chemotherapy before or after radiation therapy

You may not qualify if:

  • Prior radiation to the involved breast or chest wall
  • Concurrent chemotherapy
  • Unable or unwilling to sign informed consent
  • Unable to speak English or Spanish
  • Pregnant women
  • Clinical or pathologic stage T4
  • Metastatic disease
  • Connective tissue disorder including Systemic Lupus Erythematosus and Scleroderma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Complementary Therapies

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Jennifer J Hu, PhD

    U. of Miami

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer J Hu, PhD

CONTACT

3052437796jhu@med.miami.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 24, 2020

First Posted

December 2, 2020

Study Start

July 1, 2021

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)