Thalidomide for Preventing Radiation-Induced Dermatitis in Breast Cancer Patients (THAL-RID-BC)

November 11, 2026 updated by: Zhendong Yang, First Affiliated Hospital of Guangxi Medical University

Thalidomide for Prevention of Radiation-Induced Dermatitis in Breast Cancer Patients After Breast-Conserving Surgery Receiving Radiotherapy: A Randomized Controlled Study

To evaluate the efficacy and safety of oral thalidomide for the prevention of radiation-induced dermatitis (RID) in breast-conserving surgery patients receiving intensity-modulated whole-breast radiotherapy. This is a single-center randomized controlled trial. Female breast cancer patients aged >18 and <70 years after breast-conserving surgery scheduled for whole-breast intensity-modulated radiotherapy will be enrolled. Subjects will be randomized at a 1:1 ratio to the intervention group (thalidomide 75 mg orally every bedtime plus standard skin care) or the control group (standard skin care alone). The observation window is defined as from the start of first radiotherapy to 42 days after completion of last radiotherapy. RID will be assessed weekly according to CTCAE v5.0, and the maximum grade within the observation window will be recorded for each subject. The primary endpoint is the incidence of grade ≥2 RID within the observation window. Secondary endpoints include incidence of grade ≥3 RID, time-to-first-onset of grade ≥2 RID, RID-related symptoms (burning, pruritus, pulling pain, tenderness), quality-of-life measured by EORTC QLQ-C30 / QLQ-BR23. Treatment-emergent adverse events will be documented using CTCAE v5.0, with special attention to thalidomide-related toxicities such as somnolence, peripheral sensory neuropathy and thromboembolism. A total of 68 participants are planned for enrolment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangxi
      • Nanning, Guangxi, China, 530011
        • Recruiting
        • The First Affiliated Hospital of Guangxi Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female patients with histopathologically confirmed breast cancer after breast-conserving surgery, no distant metastasis, scheduled for intensity-modulated radiotherapy (IMRT).
  • Age greater than 18 years and less than 70 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Adequate laboratory examinations obtained within 14 days before enrolment (without prior blood transfusion): white blood cell (WBC) ≥3.0 × 10⁹/L, absolute neutrophil count (ANC) ≥1.5 × 10⁹/L, platelet (PLT) ≥100 × 10⁹/L, hemoglobin (Hb) ≥90 g/L; total bilirubin (TBIL) ≤2.0 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN; blood urea nitrogen (BUN) and creatinine (Cr) ≤1.5 × ULN, or creatinine clearance ≥60 mL/min calculated by the Cockcroft-Gault formula.
  • No prior history of breast or chest-wall radiotherapy.
  • For women of child-bearing potential: negative serum or urine pregnancy test within 72 hours prior to enrolment; fully informed of the teratogenic risk of thalidomide and agree to use dual effective contraception throughout study-drug administration and for 4 weeks after drug discontinuation; subjects refusing contraception are excluded. Post-menopausal women (amenorrhea for ≥12 consecutive months) do not require pregnancy testing.
  • Fully informed of the study content, voluntarily provide written informed consent, and are able to complete radiotherapy, study medication, scheduled assessments and follow-up visits.
  • For patients who received prior adjuvant chemotherapy: at least a 2-week interval between completion of chemotherapy and commencement of radiotherapy.

Exclusion Criteria:

  • History of other malignant tumours (except cured in situ carcinoma).
  • Psychiatric disorders or severe cognitive impairment that prevent subjects from completing questionnaires and assessments.
  • Pregnant or lactating women.
  • Poorly controlled diabetes mellitus (HbA1c > 7.5%); patients with well-controlled diabetes are eligible.
  • Active autoimmune or rheumatic diseases (systemic lupus erythematosus, dermatomyositis, scleroderma, etc.); subjects with stable mild disease without systemic medication may be considered.
  • Pre-existing or past history of peripheral neuropathy (numbness, tingling, paraesthesia); prior exposure to thalidomide, lenalidomide, pomalidomide; concomitant use of medications known to induce peripheral neurotoxicity.
  • Past history of venous thromboembolism (VTE); hereditary thrombophilia; ongoing oestrogen-containing therapy.
  • Severe cardiovascular and cerebrovascular diseases: myocardial infarction, unstable angina or stroke within the past 6 months; left ventricular ejection fraction (LVEF) < 50%.
  • Pre-existing active eczema, psoriasis, chronic dermatitis, unhealed wounds or extensive scarring within the radiation field.
  • Contraindications to radiotherapy.
  • Known hypersensitivity to thalidomide or excipients of the preparation.
  • Planned use of any additional oral or topical agents or dressings for prevention or treatment of radiation-induced dermatitis during study participation.
  • Other conditions judged by the investigator making the subject unsuitable for this clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Thalidomide plus Standard Care Group

Patients receive oral thalidomide together with standard supportive care concurrently with breast cancer radiotherapy for the prevention of radiation dermatitis.
Drug: Thalidomide tablets

Patients receive thalidomide 75 mg orally once every night at bedtime, starting from the first fraction of radiotherapy until completion of the last fraction of radiotherapy.

Other: Standard supportive care

All patients receive uniform standard skin care education and guidance for radiation field skin: wear loose fitting 100% cotton tops; avoid direct sunlight exposure to irradiated skin; keep irradiated skin dry, clean and well ventilated; avoid friction and scratching.
Active Comparator: Standard Care Control Group

Patients receive only standard supportive care during breast cancer radiotherapy, without thalidomide.
Other: Standard supportive care

All patients receive uniform standard skin care education and guidance for radiation field skin: wear loose fitting 100% cotton tops; avoid direct sunlight exposure to irradiated skin; keep irradiated skin dry, clean and well ventilated; avoid friction and scratching.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of grade ≥2 acute radiation dermatitis
Time Frame: From first radiation fraction to 42 days after completion of radiotherapy

Proportion of participants developing grade 2 or worse acute radiation dermatitis, assessed using CTCAE Version 5.0.
From first radiation fraction to 42 days after completion of radiotherapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient-reported burning symptom of radiation-induced dermatitis
Time Frame: Baseline to 42 days after completion of radiotherapy

Patient-reported severity of burning measured by a numeric rating scale (0-5; 0 = no symptom, 5 = worst imaginable symptom). Assessments are performed at baseline, weekly during radiotherapy, at the end of radiotherapy, and at 42 days after completion of radiotherapy.
Baseline to 42 days after completion of radiotherapy
Patient-reported pruritus symptom of radiation-induced dermatitis
Time Frame: Baseline to 42 days after completion of radiotherapy

Patient-reported severity of pruritus measured by a numeric rating scale (0-5; 0 = no symptom, 5 = worst imaginable symptom). Assessments are performed at baseline, weekly during radiotherapy, at the end of radiotherapy, and at 42 days after completion of radiotherapy.
Baseline to 42 days after completion of radiotherapy
Patient-reported pulling pain symptom of radiation-induced dermatitis
Time Frame: Baseline to 42 days after completion of radiotherapy

Patient-reported severity of pulling pain measured by a numeric rating scale (0-5; 0 = no symptom, 5 = worst imaginable symptom). Assessments are performed at baseline, weekly during radiotherapy, at the end of radiotherapy, and at 42 days after completion of radiotherapy.
Baseline to 42 days after completion of radiotherapy
Patient-reported tenderness symptom of radiation-induced dermatitis
Time Frame: Baseline to 42 days after completion of radiotherapy

Patient-reported severity of tenderness measured by a numeric rating scale (0-5; 0 = no symptom, 5 = worst imaginable symptom). Assessments are performed at baseline, weekly during radiotherapy, at the end of radiotherapy, and at 42 days after completion of radiotherapy.
Baseline to 42 days after completion of radiotherapy
Health-related quality of life
Time Frame: Baseline to 6 months after completion of radiotherapy

Health-related quality of life will be assessed using the EORTC QLQ-C30 questionnaires. Assessments are performed at baseline (before the first radiotherapy fraction), 42 days, 3 months and 6 months after completion of radiotherapy. A mixed-effects model will be used to analyse longitudinal changes in subscale scores. Changes from baseline in each subscale at 42 days, 3 months and 6 months after radiotherapy will be calculated and compared between groups.
Baseline to 6 months after completion of radiotherapy
Health-related quality of life QLQ-BR23
Time Frame: Baseline to 6 months after completion of radiotherapy

Health-related quality of life will be assessed using the QLQ-BR23 questionnaires. Assessments are performed at baseline (before the first radiotherapy fraction), 42 days, 3 months and 6 months after completion of radiotherapy. A mixed-effects model will be used to analyse longitudinal changes in subscale scores. Changes from baseline in each subscale at 42 days, 3 months and 6 months after radiotherapy will be calculated and compared between groups.
Baseline to 6 months after completion of radiotherapy
Adverse events and serious adverse events
Time Frame: From enrolment to at least 3 months after the last dose of study drug

Adverse events are graded according to CTCAE Version 5.0. Special attention will be paid to thalidomide-related toxicities, including somnolence, peripheral sensory neuropathy and venous thromboembolism.
From enrolment to at least 3 months after the last dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital of Guangxi Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhendong Yang, First Affiliated Hospital of Guangxi Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 12, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-S908-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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