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

11 november 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

68

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: 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.

Ander: 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.
Actieve vergelijker: Standard Care Control Group

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of grade ≥2 acute radiation dermatitis
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Patient-reported burning symptom of radiation-induced dermatitis
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

First Affiliated Hospital of Guangxi Medical University

Onderzoekers

  • Hoofdonderzoeker: Zhendong Yang, First Affiliated Hospital of Guangxi Medical University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

12 november 2026

Primaire voltooiing (Geschat)

30 juni 2028

Studie voltooiing (Geschat)

31 december 2028

Studieregistratiedata

Eerst ingediend

4 november 2026

Eerst ingediend dat voldeed aan de QC-criteria

11 november 2026

Eerst geplaatst (Werkelijk)

12 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 november 2026

Laatste update ingediend die voldeed aan QC-criteria

11 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2024-S908-01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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