Cancer, Therapy-RelatedPhase 4NCT03777930
The Evaluation of Curative Effect on Treatment of Tumor Above Thalidomide Combined With Megestrol
A Phase 4 study testing Chemotherapy drugs, thalidomide and megestrol acetate and optimal support treatment in people with Cancer, Therapy-Related, run by Shenzhen Fifth People's Hospital.
Trial summary
To observe the effect of thalidomide combined with megestrol acetate on lymphocyte, inflammatory factor regulation and nutritional status in patients with advanced malignant tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Therapy-Related
- What is being tested?
- Chemotherapy drugs, thalidomide and megestrol acetate and optimal support treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2018to 10 Jun 2021
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with advanced malignant tumor confirmed by histopathology or cytology (hepatocarcinoma can be clinical diagnosis)
- Must be able to swallow pills
- The age of the tester ≥ 18 years old
- Gender is not limited
- Kamofsky score > 20 points
- Estimated survival period ≥ 2 months
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- Childbearing age Women need negative pregnancy test
- Patients voluntarily sign informed consent and receive follow-up
- The tester can cooperate to observe adverse events and efficacy
- All of the above conditions can be included
Who cannot join
- Active upper digestive tract ulcers, obvious vomiting, chronic diarrhea, intestinal obstruction, malabsorption, etc; other patients have been known to affect drug absorption, distribution, metabolism or clearance
- 2 or more important organ dysfunction
- Thrombosis Embolism history, except for thrombosis caused by PICC
- Patients suspected of having a history of allergy to thalidomide tablets
- Any significant clinical and laboratory abnormalities that researchers believe affect safety evaluators, such as: uncontrollable activity Microbial infection, grade II or above peripheral neuropathy (NCI CTC AE v4.0), congestive heart failure, myocardial infarction within 6 months, chronic kidney disease, thyroid dysfunction etc, and acceptance may bring significant metabolic or weight changes Patients with clinical disposition
- Patients with mental disorders, affecting the efficacy of the assessor
- During the trial period and within 3 months after the end of the trial, the subject and his partner are not willing to contraception
- Any of the above can not be enrolled.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective Clinical Study of the Effect of Thalidomide Combined With Megestrol Acetate on Lymphocyte, Inflammatory Factor Regulation and Nutritional Status in Patients With Advanced Malignant Tumors
To observe the effect of thalidomide combined with megestrol acetate on lymphocyte, inflammatory factor regulation and nutritional status in patients with advanced malignant tumors.
Read the detailed description
This study was to select 200 patients with advanced tumors with an estimated survival of ≥ 2 months. 50 patients were randomly assigned to each group. The patients were divided into chemotherapy group, chemotherapy combined with thalidomide and megestrol acetate group, The best supportive treatment group, the best supportive treatment combined with thalidomide and megestrol acetate group. The chemotherapy group and the best supportive treatment group were the control group. The combined group was administered continuously for 8 weeks according to thalidomide 100 mg qn po and megestrol acetate 0.16 qd po. Calculating the sum of the longest diameters of the target lesions from each patient before and 8 week after treatment. Patients in each group before treatment, 4th week, and 7th week were observed T cell subsets, B cell subsets, NK cell subsets and the expression of inflammatory cytokines. Through nutritional assessment Table (PG-SGA), Multidimensional Deficit Power Meter (MFSI-SF), Quality of Life Assessment Scale (EORTC QLQ-C30), Prognostic Assessment Form (GPS), Physical Status Assessment Form (ECOG) and lean body mass, upper arm muscle circumference and upper arm muscle area analysis of the effect of thalidomide combined with megestrol acetate on the nutritional status of patients with advanced cancer which reveal that thalidomide combined with megestrol acetate may improve the immune regulation and nutritional status of patients with advanced malignant tumors mechanism.
- Conditions
- Cancer, Therapy-Related
- Being tested
- Chemotherapy drugs, thalidomide and megestrol acetate, optimal support treatment
- Keywords
- thalidomide, megestrol acetate, tumor, lymphocyte, inflammatory cytokines, nutritional
- Medical subject headings
- Neoplasms, Second Primary, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemotherapy drugsDrug
According to the NCCN Guidelines
thalidomide and megestrol acetateDrug
Also called Chemotherapy drugs
The thalidomide and megestrol acetate administration groups were administered with thalidomide 100 mg qn po and megestrol acetate 0.16 qd po for 8 weeks
optimal support treatmentOther
Patients who cannot tolerate chemotherapy and other cancer treatments receive optimal support for 8 weeks
thalidomide and megestrol acetateDrug
Also called optimal support treatment
The thalidomide and megestrol acetate administration groups were administered with thalidomide 100 mg qn po and megestrol acetate 0.16 qd po for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| chemotherapy group | Experimental | the patients were recepted chemotherapy alone Receives: Drug: Chemotherapy drugs |
| chemotherapy combined with TH and MG group | Experimental | the patients were recepted chemotherapy combined with thalidomide and megestrol Receives: Drug: thalidomide and megestrol acetate |
| the best supportive treatment group | Experimental | the patients were recepted the best supportive without chemotherapy Receives: Other: optimal support treatment |
| the best supportive treatment combined with TH and MG group | Experimental | the patients were recepted the best supportive combined with thalidomide and megestrol without chemotherapy Receives: Drug: thalidomide and megestrol acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging efficacy evaluation
Clinical response Based on the Response Evaluation Criteria Solid Tumors (RECIST), the therapeutic effect was divided into complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD). Investigators calculate the sum of the longest diameter of the target lesions from each patient by CT or MRI.
Measured: before and 8 week after treatment
Secondary outcomes (3)
Observing the expression of lymphocyte subsets
Patients were detected Lymphocyte subgroups of 2 ml peripheral blood by Flow cytometer (BD FACSCalibur), which inclunde the T cell subsets, NK cell subset, B cell subset(percentage)
Measured: before , the fourth and the seventh weeks of treatment
Observing the expression of inflammatory factors
2 ml of peripheral blood was taken from each patient. Flow cytometry was used to detect changes of inflammatory factor expression which include the IL-2, IL- 4, IL-5, IL-6, IL-9, IL-10, IL-13, IL-17A, IL-17F, IL-21, IL-22, IFN-γ and TNF-α(ug/ml)
Measured: before , the fourth and the seventh weeks of treatment
Nutritional assessment
Scored Patient-Generated Subjiective Global Assessment（PG-SGA）form was used in the present study. The total score of PG-SGA is summed by the following four subscale scores（A+B+C+D）. The first measurement score（A）is self-assessed by the subject and consists of the following four parts: Weight Table（0-4），Eating Situation Table（0-6），Symptom Table （0-22），Activity and Body Function Table（0-3）. The remaining three measurements are completed by trained registered clinical physicians， dieticians，and nurses: Scale of relationship between disease and nutritional needs（B）（0-6），Metabolic demand scale（C）（0-9），Physical examination scale（D）（0-24）. The scoring was controlled by one researcher (H.R). The lower scores represent a better outcome and the higher scores represent a worse outcome.
Measured: before , the fourth and the seventh weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start10 Dec 2018 (estimated)
- Primary completion10 Oct 2020 (estimated)
- Study completion10 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, Therapy-RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 200 patients with advanced tumors with a predicted survival period of ≥2 months were selected, including 100 patients with chemotherapy indications (50 patients were divided into chemotherapy group and 50 patients were divided into chemotherapy combined with TH and MG group according to the random principle) and 100 patients without chemotherapy indications (50 patients were randomly divided into the best supportive treatment group and 50 patients were randomly divided into the best supportive treatment group with TH and MG according to the random principle). The chemotherapy alone group and the best supportive treatment group were the control group. The thalidomide and megestrol acetate administration groups were administered with thalidomide 100 mg qn po and megestrol acetate 0.16 qd po for 8 weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Fifth People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777930
- Sponsor's protocol ID
- shenzhenfifth 201807
- Status last verified
- Dec 2018
- First submitted
- 25 Aug 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study of the Effect of Thalidomide Combined With Megestrol Acetate on Lymphocyte, Inflammatory Factor Regulation and Nutritional Status in Patients With Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT03777930
- Acronym / sponsor ID
- shenzhenfifth 201807
- Conditions
- Cancer, Therapy-Related
- Keywords
- thalidomide, megestrol acetate, tumor, lymphocyte, inflammatory cytokines, nutritional
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shenzhen Fifth People's HospitalUniversity, hospital or other
- Study start
- 10 Dec 2018 (estimated)
- Primary completion
- 10 Oct 2020 (estimated)
- Study completion
- 10 Jun 2021 (estimated)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To observe the effect of thalidomide combined with megestrol acetate on lymphocyte, inflammatory factor regulation and nutritional status in patients with advanced malignant tumors.
Detailed description
This study was to select 200 patients with advanced tumors with an estimated survival of ≥ 2 months. 50 patients were randomly assigned to each group. The patients were divided into chemotherapy group, chemotherapy combined with thalidomide and megestrol acetate group, The best supportive treatment group, the best supportive treatment combined with thalidomide and megestrol acetate group. The chemotherapy group and the best supportive treatment group were the control group. The combined group was administered continuously for 8 weeks according to thalidomide 100 mg qn po and megestrol acetate 0.16 qd po. Calculating the sum of the longest diameters of the target lesions from each patient before and 8 week after treatment. Patients in each group before treatment, 4th week, and 7th week were observed T cell subsets, B cell subsets, NK cell subsets and the expression of inflammatory cytokines. Through nutritional assessment Table (PG-SGA), Multidimensional Deficit Power Meter (MFSI-SF), Quality of Life Assessment Scale (EORTC QLQ-C30), Prognostic Assessment Form (GPS), Physical Status Assessment Form (ECOG) and lean body mass, upper arm muscle circumference and upper arm muscle area analysis of the effect of thalidomide combined with megestrol acetate on the nutritional status of patients with advanced cancer which reveal that thalidomide combined with megestrol acetate may improve the immune regulation and nutritional status of patients with advanced malignant tumors mechanism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 200 patients with advanced tumors with a predicted survival period of ≥2 months were selected, including 100 patients with chemotherapy indications (50 patients were divided into chemotherapy group and 50 patients were divided into chemotherapy combined with TH and MG group according to the random principle) and 100 patients without chemotherapy indications (50 patients were randomly divided into the best supportive treatment group and 50 patients were randomly divided into the best supportive treatment group with TH and MG according to the random principle). The chemotherapy alone group and the best supportive treatment group were the control group. The thalidomide and megestrol acetate administration groups were administered with thalidomide 100 mg qn po and megestrol acetate 0.16 qd po for 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| chemotherapy group | Experimental | Drug: Chemotherapy drugsthe patients were recepted chemotherapy alone |
| chemotherapy combined with TH and MG group | Experimental | Drug: thalidomide and megestrol acetatethe patients were recepted chemotherapy combined with thalidomide and megestrol |
| the best supportive treatment group | Experimental | Other: optimal support treatmentthe patients were recepted the best supportive without chemotherapy |
| the best supportive treatment combined with TH and MG group | Experimental | Drug: thalidomide and megestrol acetatethe patients were recepted the best supportive combined with thalidomide and megestrol without chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with advanced malignant tumor confirmed by histopathology or cytology (hepatocarcinoma can be clinical diagnosis)
- Must be able to swallow pills
- The age of the tester ≥ 18 years old
- Gender is not limited
- Kamofsky score > 20 points
Key exclusion criteria (8 listed)
- Active upper digestive tract ulcers, obvious vomiting, chronic diarrhea, intestinal obstruction, malabsorption, etc; other patients have been known to affect drug absorption, distribution, metabolism or clearance
- 2 or more important organ dysfunction
- Thrombosis Embolism history, except for thrombosis caused by PICC
- Patients suspected of having a history of allergy to thalidomide tablets
- Any significant clinical and laboratory abnormalities that researchers believe affect safety evaluators, such as: uncontrollable activity Microbial infection, grade II or above peripheral neuropathy (NCI CTC AE v4.0), congestive heart failure, myocardial infarction within 6 months, chronic kidney disease, thyroid dysfunction etc, and acceptance may bring significant metabolic or weight changes Patients with clinical disposition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chemotherapy drugsAccording to the NCCN Guidelines | Drug | chemotherapy group |
| thalidomide and megestrol acetateAlso: Chemotherapy drugsThe thalidomide and megestrol acetate administration groups were administered with thalidomide 100 mg qn po and megestrol acetate 0.16 qd po for 8 weeks | Drug | chemotherapy combined with TH and MG group |
| optimal support treatmentPatients who cannot tolerate chemotherapy and other cancer treatments receive optimal support for 8 weeks | Other | the best supportive treatment group |
| thalidomide and megestrol acetateAlso: optimal support treatmentThe thalidomide and megestrol acetate administration groups were administered with thalidomide 100 mg qn po and megestrol acetate 0.16 qd po for 8 weeks | Drug | the best supportive treatment combined with TH and MG group |
Primary outcome
Imaging efficacy evaluation
Time frame: before and 8 week after treatment
Clinical response Based on the Response Evaluation Criteria Solid Tumors (RECIST), the therapeutic effect was divided into complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD). Investigators calculate the sum of the longest diameter of the target lesions from each patient by CT or MRI.
3 secondary outcomes
Observing the expression of lymphocyte subsets
Time frame: before , the fourth and the seventh weeks of treatment
Observing the expression of inflammatory factors
Time frame: before , the fourth and the seventh weeks of treatment
Nutritional assessment
Time frame: before , the fourth and the seventh weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chemotherapy drugs, thalidomide and megestrol acetate and optimal support treatment in people with Cancer, Therapy-Related, run by Shenzhen Fifth People's Hospital.
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 10 inclusion and 8 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 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 yangwei w yang, master (13826524554 ext. 0755-82646002, junweiyang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging efficacy evaluation (time frame: before and 8 week after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2018.