Assessing the feasibility of pharmacologically induced hypothyroidism in patients with advanced pancreatic cancer

Assessing the feasibility of pharmacologically induced hypothyroidism in patients with advanced pancreatic cancer - a pilot study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-006055-33-AT

Enrollment

Registered

2023-01-27

Start date

2023-03-05

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with newly diagnosed metastatic pancreatic cancer

Interventions

Trade Name: Thiamazol Product Name: Thiamzol Pharmaceutical Form: Tablet INN or Proposed INN: Thiamazol Other descriptive name: THIAMAZOLE Concentration unit: mg milligram(s) Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • > 18 years • Histologically proven malignancy (pancreatic ductal adenocarcinoma) • Radiologically confirmed metastatic disease by RECIST criteria • Leucocyte count > 3 G/l Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 6 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4

Exclusion criteria

Exclusion criteria: • Current thyreostatic therapy • Current T4 or T3 substitution therapy • TSH 4 uIU/ml • AST, ALT > 3x ULN • GFR < 30 ml/min • Known allergy against methimazole • Pregnancy / breastfeeding • ECOG = 2 • Participation in another interventional study

Design outcomes

Primary

Measure	Time frame
Main Objective: We aim to test the feasibility of Methimazole at a starting dose of 5 mg/day in patients with advanced pancreatic cancer ;Secondary Objective: We aim to test the effects of pharmacologically induced subclinical hypothyroidism on cancer progression compared to a retrospective control group matched for sex, age, cancer entity, stage of disease and chemotherapy regimens. ;Primary end point(s): •Presence of subclinical hypothyroidism (TSH > 4 uIU/ml) after 12 weeks treatment with methimazole;Timepoint(s) of evaluation of this end point: After 12 weeks of treatment	—

Measure

Time frame

Main Objective: We aim to test the feasibility of Methimazole at a starting dose of 5 mg/day in patients with advanced pancreatic cancer ;Secondary Objective: We aim to test the effects of pharmacologically induced subclinical hypothyroidism on cancer progression compared to a retrospective control group matched for sex, age, cancer entity, stage of disease and chemotherapy regimens. ;Primary end point(s): •Presence of subclinical hypothyroidism (TSH > 4 uIU/ml) after 12 weeks treatment with methimazole;Timepoint(s) of evaluation of this end point: After 12 weeks of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): • quality of life (ThyPRO; EORTC QLQ-C30 Version 3; EORTC QLQ-FA12) • number of interruptions of methimazole treatment due to fatigue • number of interruptions of methimazole treatment due to leucopenia • number of interruptions of methimazole treatment due to elevated liver parameters • progression-free survival (interval from start of chemotherapy until progression of disease or death of any cause) • best clinical benefit rate (stable disease + partial response + complete response) compared to the matched control group • best objective response rate (partial response + complete response) compared to the matched control group • CRP/Albumin ratio after 12 weeks compared to the matched control group • Neutrophil-to-lymphocyte ratio after 12 weeks compared to the matched control group • Leucocyte-to-lymphocyte ratio after 12 weeks compared to the matched control group • Platelet-to-lymphocyte ratio after 12 weeks compared to the matched control group • Monocyte-to-lymphocyte ratio after 12 weeks compared to the matched control group • CA 19-9, CEA after 12 weeks compared to the matched control group;Timepoint(s) of evaluation of this end point: After 12 weeks of treatment	—

Measure

Time frame

Secondary end point(s): • quality of life (ThyPRO; EORTC QLQ-C30 Version 3; EORTC QLQ-FA12) • number of interruptions of methimazole treatment due to fatigue • number of interruptions of methimazole treatment due to leucopenia • number of interruptions of methimazole treatment due to elevated liver parameters • progression-free survival (interval from start of chemotherapy until progression of disease or death of any cause) • best clinical benefit rate (stable disease + partial response + complete response) compared to the matched control group • best objective response rate (partial response + complete response) compared to the matched control group • CRP/Albumin ratio after 12 weeks compared to the matched control group • Neutrophil-to-lymphocyte ratio after 12 weeks compared to the matched control group • Leucocyte-to-lymphocyte ratio after 12 weeks compared to the matched control group • Platelet-to-lymphocyte ratio after 12 weeks compared to the matched control group • Monocyte-to-lymphocyte ratio after 12 weeks compared to the matched control group • CA 19-9, CEA after 12 weeks compared to the matched control group;Timepoint(s) of evaluation of this end point: After 12 weeks of treatment

—

Countries

Austria

Contacts

Public ContactInternal Medicine III

Medical University of Vienna

peter.wolf@meduniwien.ac.at

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026