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Chemotherapy-induced Nausea and VomitingNCT03601871

The Efficacy and Safety of Thalidomide in Preventing CINV Induced by Cisplatin-containing Chemotherapy

A study testing Thalidomide, Dexamethasone and 5-HT3 antagonists in people with Chemotherapy-induced Nausea and Vomiting, run by Yunpeng Liu at 29 sites in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Trial summary

This is a pragmatic randomized, multi-center, open-label randomized clinical trial, aimed to evaluate efficacy and safety of thalidomide in improving prevention of chemotherapy-induced delayed nausea and vomiting (CINV) in chemotherapy-naive patients after multi-cycle cisplatin-containing highly emetogenic… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chemotherapy-induced Nausea and Vomiting
What is being tested?
Thalidomide, Dexamethasone and 5-HT3 antagonists
Could I receive a placebo?
No, everyone receives an active treatment
How many people
880 participants
Where
29 sitesChina
Study dates
12 Jul 2018to 30 Dec 2020
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18y ≤Age≤70y
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • Histologically confirmed solid neoplasm
  • No prior chemotherapy
  • Laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/ L, neutrophil count ≥1.5×109/L, platelet count ≥85×109/L, creatinine clearance rate (CCr) ≥60ml/min, total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), blood glucose ≤11.1 mmol/L
  • Life expectancy of at least 12 weeks
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  • Signed informed consent
  • For women with child bearing potential, a negative serum or urine pregnancy test result should be obtained before enrollment;the patients and their couples should receive contraception for at least 3 years after their last dosage of thalidomide.
  • Cancer patients scheduled to receive chemotherapy containing a 50 mg/m2 or higher dose of cisplatin for 4-6 cycles

Who cannot join

  • Diabetic patients
  • Pregnant or lactated women
  • Patient with history of severe thrombosis
  • Concomitant radiotherapy
  • Known hypersensitivity yo thalidomide, palonosetron, or dexamethasone.
  • Concurrent administration of any other drug which affect antiemetic effect evaluation such as proton pump inhibitor, H2 blocker, amifostine, sedative drugs
Show all 13Show fewer
  • Cyclophosphamide, hydroxydaunomycin, Oncovin, and prednisone (CHOP )regiment or taxanes-based regiment
  • Existing emesis within 24 hours before chemotherapy administration
  • Symptomatic brain metastasis or suspected clinical brain metastasis
  • Serious uncontrolled systemic illness or medical condition: congestive heart failure, unstable angina, history of documented myocardial infarction within 6 months, uncontrolled hypertension and high risk uncontrollable arrhythmias; Obvious neurological or mental abnormalities including mental disorder, epileptic dementia, which affect compliance; Uncontrolled acute infections; Uncontrolled peptic ulcer or other contraindication for corticosteroid therapy.
  • Inability to take or absorb oral medicine
  • Concurrent administration of any other investigational drug, or have been enrolled in other clinical trial with investigational drug treatment within the 30 days of start of study treatment
  • Unsuitable for the study or other chemotherapy determined by investigator

Trial locations and contacts

29 sites in 1 country.

Xiujuan Qu, PhD. M.D. contact

024-83282542

qu_xiujuan@hotmail.com

Lingyun Zhang, PhD. M.D. contact

024-83282312

zhangly1105@126.com

29 sites in 1 country

China29 sites, 29 recruiting

  • Anshan Hospital of First Hospital of China Medical University

    Anshan, Liaoning

    Mingran Sun, PhD.M.D.

    Mingran Sun

    Not yet recruiting

  • Anshan Tumor Hospital

    Anshan, Liaoning

    Xiuna Zhang, M.D.

    Xiuna Zhang

    Not yet recruiting

  • Central Hospital of Anshan City

    Anshan

    Chuanchun Leng

    Chuanchun Leng

    Not yet recruiting

  • Benxi Central Hospital

    Benxi

    Tiejun Chen

    Tiejun Chen

    Not yet recruiting

  • Chaoyang Central Hospital

    Chaoyang

    Xiujie Cui

    Xiujie Cui

    Not yet recruiting

  • Central hospital of Dalian

    Dalian, Liaoning

    Wei Huo

    Wei huo

    Not yet recruiting

  • Second Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning

    Zhaoxia Dai, M.D.

    Zhaoxia Dai

    Not yet recruiting

  • The Fifth Hospital of Dalian City

    Dalian, Liaoning

    Jilai Bian

    Jilai Bian

    Not yet recruiting

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning

    Jiwei Liu, PhD;M.D.

    Jiwei Liu

    Not yet recruiting

  • Zhuanghe Central Hospital

    Dalian, Liaoning

    Huali Tang

    Huali Tang

    Not yet recruiting

  • Zhongshan Hospital

    Dalian

    Xuening Ji, M.D.

    Xuening Ji

    Not yet recruiting

  • Fushun Central Hospital

    Fushun, Liaoning

    Li Ning

    Li Ning

    Recruiting

  • General Hospital of Mining Bureau

    Fushun, Liaoning

    Yuyang Zhang

    Yuyang Zhang

    Not yet recruiting

  • cancer hospital of Haerbin Medical University

    Haerbin, Heilongjiang

    Jin Wu, M.D.

    Not yet recruiting

  • Jinzhou Central Hospital

    Jinzhou, Liaoning

    Wei Wang

    Wei Wang

    Not yet recruiting

  • The First Hospital of Liaoning Medical University

    Jinzhou, Liaoning

    Zhitu Zhu

    Zhitu Zhu

    Not yet recruiting

  • Chinese Medicine Hospital of Liaoyang county

    Liaoyang, Liaoning

    Haifeng Liu, M.D.

    Haifeng Liu

    Not yet recruiting

  • Liaoyang Central Hospital

    Liaoyang, Liaoning

    Jian Zhang, M.D.

    Jian Zhang

    Not yet recruiting

  • Petrochemical General Hospital of Liaoyang city

    Liaoyang, Liaoning

    Hao Chen

    Hao Chen

    Not yet recruiting

  • Panjin central Hospital

    Panjin, Liaoning

    Junwei Zhang

    Junwei Zhang

    Not yet recruiting

  • Liaohe Oilfield General Hospital

    Panjin

    Qiang Chen

    Qiang Chen

    Not yet recruiting

  • Chest Hospital of Shenyang City

    Shengyang, Liaoning

    Yinyin Li

    Yinyin Li

    Not yet recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

    Huawei Zou, M.D.

    Huawei Zou

    Not yet recruiting

  • General Hospital of Shenyang Military Region

    Shenyang, Liaoning

    Zhendong Zheng

    Not yet recruiting

  • Liaoning Tumor Hospital & Institute

    Shenyang, Liaoning

    Yu Tang, M.D.

    Yu Tang

    Not yet recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning

    Yunpeng Liu, M.D.;Ph.D.

    Yunpeng Liu

    Recruiting

  • the People'S Hospital

    Shenyang, Liaoning

    Lijie He, M.D.

    Lijie He

    Not yet recruiting

  • Siping City Cancer Hospital

    Siping, Jilin

    Zhuohui Qu

    Zhuohui Qu

    Not yet recruiting

  • Tieling city Central Hospital

    Tieling, Liaoning

    Huijun Zhang

    Huijun Zhang

    Not yet recruiting

Other trials in China

About this study

Official title: The Efficacy and Safety of Thalidomide in Preventing Multi-cycle, Cisplatin-containing CINV: a Pragmatic Randomized Open-label Clinical Trial

This is a pragmatic randomized, multi-center, open-label randomized clinical trial, aimed to evaluate efficacy and safety of thalidomide in improving prevention of chemotherapy-induced delayed nausea and vomiting (CINV) in chemotherapy-naive patients after multi-cycle cisplatin-containing highly emetogenic chemotherapy (HEC) .

Read the detailed description

This is a pragmatic randomized, multi-center, open-label randomized clinical trial, aimed to evaluate efficacy and safety of thalidomide in improving prevention of chemotherapy-induced delayed nausea and vomiting (CINV) in chemotherapy-naive patients after multi-cycle cisplatin-containing highly emetogenic chemotherapy (HEC) . A total of 880 patients are planned to be enrolled into the study. Chemotherapy-naïve patients treated with multi-cycle cisplatin-containing chemotherapy will be randomized into two groups(thalidomide group and control group), and be treated with Thalidomide+5-hydroxytryptamine receptor(5-HT3) antagonist +Dexamethasone (Thalidomide group) or 5-HT3 antagonist + Dexamethasone(control group), respectively. The primary end point is no nausea rate in delayed phase of the first cycle chemotherapy, and the secondary end points include the complete response rate of vomiting in acute,delayed and overall period; no nausea rate in acute and overall phase; anorexia score, fatigue score and sedation score assessed by VAS ; safety and quality of life (QOL) during multi-cycle chemotherapy.

Being tested
Thalidomide, Dexamethasone, 5-HT3 antagonists
Keywords
Thalidomide, Chemotherapy-induced Nausea and Vomiting, cisplatin
Medical subject headings
Vomiting

What participants receive

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

  • ThalidomideDrug

    Thalidomide (Thalidomide Oral Product)100 mg by mouth twice a day on days 1-5 after chemotherapy .

  • DexamethasoneDrug

    Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4

  • 5-HT3 antagonistsDrug

    Also called Palonosetron, or 1st-generation 5-HT3 antagonists

    Palonosetron 0.25 mg intravenously on day 1; or 1st-generation 5-HT3 antagonists (used as clinal routine) on day 1-3

Study groups in NCT03601871
Study groupRoleWhat they receive
Control groupActive comparatorPalonosetron 0.25 mg intravenously on day 1; or 1st-generation 5-HT3 antagonists (used as clinal routine) on day 1-3; Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4.
Receives: Drug: Dexamethasone; Drug: 5-HT3 antagonists
Thalidomide groupExperimentalThalidomide 100 mg by mouth twice a day on days 1-5; Palonosetron 0.25 mg intravenously on day 1; or 1st-generation 5-HT3 antagonists (used as clinal routine) on day 1-3; Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4.
Receives: Drug: Thalidomide; Drug: Dexamethasone; Drug: 5-HT3 antagonists

What is being measured

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

  1. No nausea （self report sclae VAS=0）rate in delayed phase (Days2-7) in the first cycle chemotherapy

    The rate of no nausea on Day 2-7 in the first chemotherapy cycle (each cycle is 21 days).

    The no nausea is defined as score zero with a self-report measure scale,the visual analogue (VAS) scale (0,no symptom, 10, most severely).

    Measured: Day 2-7 in the first chemotherapy cycle(each cycle is 21 days)

Secondary outcomes (7)

  1. No nausea rates （VAS=0）for delayed phases (Days2-7) during 2nd to 4th or 6th chemotherapy cycle,respectively.

    The rates of no nausea on day 2-7 in 2nd-4th or 6th cycle (each cycle is 21 days).

    The no nausea is defined as score zero with a self-report measure scale,the visual analogue (VAS) scale (0,no symptom, 10, most severely).

    Measured: Day 2-7 in each chemotherapy cycle (each cycle is 21 days)

  2. The complete response rates of vomiting (no emetic episode and no rescue) in acute (Day1),delayed(Day2-7), and overall phase(Day 1-7) during 1st to 4th or 6th cycle, respectively.

    The rates of no emetic episode and no rescue in acute(Day1),delayed(Day2-7), and overall phase(Day 1-7) during 1st to 4th or 6th cycle, respectively.(each cycle is 21 days). An emetic episode is defined as one occurrence of vomiting or a sequence of occurrences in close succession not relieved by a rest period of at least 1 min; any number of episodes of retching in a 5-minute period; or an episode of retching of , 5 minutes combined with vomiting not relieved in a 1-minute period.

    Measured: Day 1-7 in 4-6 cycles(each cycle is 21 days)

  3. The rate of no anorexia (VAS=0) and score of anorexia (assessed by VAS) in Day1-7 during 1st-4th or 6th cycle chemotherapy

    The rate of no anorexia (VAS=0) and score of anorexia assessed by VAS in multi-cycle chemotherapy. Anorexia score is evaluated with VAS (0,no symptom, 10, most severely)

    Measured: Day 1-7 in each cycle(each cycle is 21 days)

  4. The score of fatigue by VAS in day1-7 in1st to 4th or 6th chemotherapy cycle,respectively.

    The score of fatigue by self-report scale VAS in day1-7 in1st to 4th or 6th chemotherapy. fatigue is evaluated with self-report scale VAS (0,no symptom, 10, most severely）

    Measured: Day 1-7 in each cycle(each cycle is 21 days)

  5. The score of sedation(by self-report VAS) in day 1-7 in each cycle

    The score of sedation(by self-report VAS) in day 1-7 in each cycle, respectively.Sedation is evaluated with self-report VAS (0,no symptom, 10, most severely）

    Measured: Day 1-7 in each cycle(each cycle is 21 days)

  6. Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 in multi-cycle chemotherapy

    Number of participants with Treatment-Related Adverse Events as assessed by CTCAE v4.0, in 4-6 cycles (each cycle is 21 days).

    Measured: Day 1-21 in each cycle(each cycle is 21 days) during 4-6 chemotherapy cycles (each cycle is 21 days)

  7. The quality of life scores (evaluated with Functional Living Index-Emesis (FLIE) questionnaire) of patients when receiving multi-cycle chemotherapy

    The change of quality of life scores from baseline of patients (before chemotherapy) to D8 after chemotherapy in each cycle (each cycle is 21 days). The quality of life are evaluated with Functional Living Index-Emesis (FLIE) questionnaire.

    Measured: Day 1-8 in each cycle(each cycle is 21 days) during 4-6 chemotherapy cycles.

Timeline

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

  1. First posted26 Jul 2018
  2. Study start12 Jul 2018
  3. Primary completion30 Jun 2020 (estimated)
  4. Study completion30 Dec 2020 (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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
880 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03601871
Sponsor's protocol ID
CLOG1801
Status last verified
Jul 2018
First submitted
30 May 2018
Last updated
26 Jul 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Thalidomide, Dexamethasone and 5-HT3 antagonists in people with Chemotherapy-induced Nausea and Vomiting, run by Yunpeng Liu at 29 sites in China.

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 9 inclusion and 13 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 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in China. 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 Xiujuan Qu, PhD. M.D. (024-83282542, qu_xiujuan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

No nausea （self report sclae VAS=0）rate in delayed phase (Days2-7) in the first cycle chemotherapy (time frame: Day 2-7 in the first chemotherapy cycle(each cycle is 21 days)). 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 NCT03601871.

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 26 Jul 2018.

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