Thyroid CancerNCT05265819
Effect of Exergaming Exercises and Mediterranean Diet on Thyroid Cancer Patients Following Total Thyroidectomy
A study testing X-BOX kinetic360, mediterranean diet and thyroid hormone replacement therapy in people with Thyroid Cancer, run by Nabil Mahmoud Ismail Abdel-Aal at 1 site in Egypt.
Trial summary
Effect of exergaming exercises and mediteranean diet on thyroid cancer patients following total thyroidectomy adult patients from both gender will be randomly assigned equally to exergaming exercises, Mediterranean diet groups using computer-generated block randomization. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- X-BOX kinetic360, mediterranean diet and thyroid hormone replacement therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 5 Jul 2025
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of thyroid papillary carcinoma as it is the most common type
- Treatment with thyroid hormone medication after thyroidectomy
- Lack of radioactive iodine treatment within the past 6 months
- Blood hemoglobin level >10 g/dL.
- Not taking drugs that could affect their immune function (e.g., immunosuppressants such as cyclosporin and steroids .
- Lack of regular exercise
Show all 9Show fewer
- Age 18~45 years
- Dose should be controlled at the first one year
- -
Who cannot join
- 1) Abscess or inflammation suspected by preoperative tests 2) Patients with stage IV cancer and with limited understanding of assessment systems 3) History of head or neck malignancy . 4) Radiation therapy 5) Graves disease 6) Thyroiditis 7) Orthopaedic and rheumatic conditions of the neck . 8) The patient's inability to cooperate
- -
Trial locations and contacts
1 site in 1 country.
About this study
Effect of exergaming exercises and mediteranean diet on thyroid cancer patients following total thyroidectomy adult patients from both gender will be randomly assigned equally to exergaming exercises, Mediterranean diet groups using computer-generated block randomization.
Group A: Control group No intervention was provided for 12 weeks except thyroid hormone replacement therapy Group B: Exergaming exercise The volunteers carried out 36 exergaming sessions, with progressive increase in the duration of the games according to their tolerance,and reached a maximum duration of 50 minutes per session, included the realization of the games and the rest between activities. The exergaming protocol was performed three times a week, for a total of 12 weeks Group C: Mediterranean diet All participants participated in the Mediterranean diet intervention for 12 weak and received dietary training from professional nutritionists at the baseline visit and samples of a Mediterranean diet for three times during the trial.PREDIMED questionnaire is used To assess adherence to the Mediterranean diet Group D: Exergaming exercises and Mediterranean diet Exergaming exercises are used in addition to Mediterranean diet
Read the detailed description
Outcome measures
- Flow cytometry analyzer for NKC (CD3- CD16+ CD56+).
- Immunoassay analyzer for thyroid profile (TSH,T3,T4)
- Quality of life questionnaire
- Fatigue questionnaire
- PREDIMED questionnaire to asses diet adherence. Outcome measures will be measured at baseline and after 3 months of the treatement intervention
- assessment
- Quality of life questionnaire questionnaire
- .Fatigue questionnaire
- Adherence to diet A validated 14-item questionnaire for the assessment of adherence to the Mediterranean Diet (PREDIMED) will be recorded for all the enrolled subjects
- Biochemical Analysis. [B] Intervention
- Exergaming The practice of exergaming was performed using the Xbox 360 Kinect console (Microsoft, Albuquerque, NM)
- Mediterranean diet All participants participated in the Mediterranean diet intervention for 12 weak and received dietary training from professional nutritionists at the baseline visit and samples of a Mediterranean diet for three times during the trial. 4 groups will be randomly assigned Group A: Control group No intervention was provided for 12 weeks except thyroid hormone replacement therapy Group B: Exergaming exercise The volunteers carried out 36 exergaming sessions, with progressive increase in the duration of the games according to their tolerance,and reached a maximum duration of 50 minutes per session, included the realization of the games and the rest between activities. The exergaming protocol was performed three times a week, for a total of 12 weeks Group C: Mediterranean diet All participants participated in the Mediterranean diet intervention for 12 weak and received dietary training from professional nutritionists at the baseline visit and samples of a Mediterranean diet for three times during the trial.PREDIMED questionnaire is used To assess adherence to the Mediterranean diet Group D: Exergaming exercises and Mediterranean diet Exergaming exercises are used in addition to Mediterranean diet
- Conditions
- Thyroid Cancer
- Being tested
- X-BOX kinetic360, mediterranean diet, thyroid hormone replacement therapy
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-BOX kinetic360Device
Also called thyroid hormone replacement therapy
- Exergaming The practice of exergaming was performed using the Xbox 360 Kinect console,The volunteers carried out 36 exergaming sessions, with progressive increase in the duration of the games according to their tolerance,and reached a maximum duration of 50 minutes per session, included the realization of the games and the rest between activities. The exergaming protocol was performed two to three times a week, for a total of 12 weeks.
mediterranean dietDietary supplement
Also called thyroid hormone replacement therapy
Mediterranean diet participants participated in the Mediterranean diet intervention for 12 weak and received dietary training from professional nutritionists at the baseline visit and samples of a Mediterranean diet for three times during the trial.
thyroid hormone replacement therapyDrug
thyroid hormone replacement therapy
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A: Control group No intervention was provided for 12 weeks except thyroid hormone replacement therapy Receives: Drug: thyroid hormone replacement therapy |
| Group B | Experimental | Group B: Exergaming exercise The volunteers carried out 36 exergaming sessions Receives: Device: X-BOX kinetic360 |
| Group C | Experimental | Group C: Mediterranean diet participants participated in the Mediterranean diet intervention for 12 weak and received dietary training from professional nutritionists at the baseline visit and samples of a Mediterranean diet for three times during the trial. Receives: Dietary Supplement: mediterranean diet |
| Group D | Experimental | Group D: Exergaming exercises and Mediterranean diet Exergaming exercises are used in addition to Mediterranean diet Receives: Device: X-BOX kinetic360; Dietary Supplement: mediterranean diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD3-
CD3 (cluster of differentiation 3) is a protein complex and T cell co-receptor that is involved in activating both the cytotoxic T cell (CD8+ naive T cells) and T helper cells (CD4+ naive T cells). It is composed of four distinct chains.
blood sample taken from the patients
Measured: 3 months
CD16+
CD16 is involved in antibody-dependent cell-mediated cytotoxicity and is expressed on large granular lymphocytes (LGLs) of both NK- and T-cell types.blood sample taken from the patients
Measured: 3 months
CD56+
CD56, is a member of the immunoglobulin superfamily engaged in both so-called homophilic and heterophilic interactions.blood sample taken from the patients
Measured: 3 months
Secondary outcomes (5)
TSH(thyroid stimulating hormone)
TSH stands for thyroid stimulating hormone. A TSH test is a blood test that measures this hormone.
Measured: 3 months
T3 (triiodothyronine)
This test measures the level of triiodothyronine (T3) in your blood. T3 is one of two major hormones made by your thyroid
Measured: 3 months
T4 (Thyroxine)
Thyroxine, also known as T4, is a type of thyroid hormone. This test measures the level of T4 in your blood. Too much or too little T4 can indicate thyroid disease.
Measured: 3 months
Quality of life questionnaire
The World Health Organization (WHO) defined Quality of Life (QoL) as "an individual's perception of their position in life, in the context of the culture and value systems in which they live, and in relation to their goals, expectations, standards and concerns" . QoL is comprised of multiple aspects, including psychological health, physical well-being, social relationships, and environmental conditions [.
Measured: 3 months
Fatigue questionnaire
questionnaire is applied to the patients
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start1 Mar 2022
- Primary completion5 Jul 2025
- Study completion5 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nabil Mahmoud Ismail Abdel-Aal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nabil Mahmoud Ismail Abdel-Aal, Cairo University
- Investigators
- Mohsen Elsayyad, PhD, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265819
- Sponsor's protocol ID
- P.T.REC/012/003356
- Status last verified
- Apr 2026
- First submitted
- 23 Feb 2022
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I will share my data
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exergaming Exercises and Mediterranean Diet on Thyroid Cancer Patients Following Total Thyroidectomy
- ClinicalTrials.gov ID
- NCT05265819
- Acronym / sponsor ID
- P.T.REC/012/003356
- Conditions
- Thyroid Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Nabil Mahmoud Ismail Abdel-AalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 5 Jul 2025 (actual)
- Study completion
- 5 Jul 2025 (actual)
- First posted
- 4 Mar 2022 (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.
Effect of exergaming exercises and mediteranean diet on thyroid cancer patients following total thyroidectomy adult patients from both gender will be randomly assigned equally to exergaming exercises, Mediterranean diet groups using computer-generated block randomization.
Group A: Control group No intervention was provided for 12 weeks except thyroid hormone replacement therapy Group B: Exergaming exercise The volunteers carried out 36 exergaming sessions, with progressive increase in the duration of the games according to their tolerance,and reached a maximum duration of 50 minutes per session, included the realization of the games and the rest between activities. The exergaming protocol was performed three times a week, for a total of 12 weeks Group C: Mediterranean diet All participants participated in the Mediterranean diet intervention for 12 weak and received dietary training from professional nutritionists at the baseline visit and samples of a Mediterranean diet for three times during the trial.PREDIMED questionnaire is used To assess adherence to the Mediterranean diet Group D: Exergaming exercises and Mediterranean diet Exergaming exercises are used in addition to Mediterranean diet
Detailed description
Outcome measures
- Flow cytometry analyzer for NKC (CD3- CD16+ CD56+).
- Immunoassay analyzer for thyroid profile (TSH,T3,T4)
- Quality of life questionnaire
- Fatigue questionnaire
- PREDIMED questionnaire to asses diet adherence. Outcome measures will be measured at baseline and after 3 months of the treatement intervention
- assessment
- Quality of life questionnaire questionnaire
- .Fatigue questionnaire
- Adherence to diet A validated 14-item questionnaire for the assessment of adherence to the Mediterranean Diet (PREDIMED) will be recorded for all the enrolled subjects
- Biochemical Analysis. [B] Intervention
- Exergaming The practice of exergaming was performed using the Xbox 360 Kinect console (Microsoft, Albuquerque, NM)
- Mediterranean diet All participants participated in the Mediterranean diet intervention for 12 weak and received dietary training from professional nutritionists at the baseline visit and samples of a Mediterranean diet for three times during the trial. 4 groups will be randomly assigned Group A: Control group No intervention was provided for 12 weeks except thyroid hormone replacement therapy Group B: Exergaming exercise The volunteers carried out 36 exergaming sessions, with progressive increase in the duration of the games according to their tolerance,and reached a maximum duration of 50 minutes per session, included the realization of the games and the rest between activities. The exergaming protocol was performed three times a week, for a total of 12 weeks Group C: Mediterranean diet All participants participated in the Mediterranean diet intervention for 12 weak and received dietary training from professional nutritionists at the baseline visit and samples of a Mediterranean diet for three times during the trial.PREDIMED questionnaire is used To assess adherence to the Mediterranean diet Group D: Exergaming exercises and Mediterranean diet Exergaming exercises are used in addition to Mediterranean diet
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: thyroid hormone replacement therapyGroup A: Control group No intervention was provided for 12 weeks except thyroid hormone replacement therapy |
| Group B | Experimental | Device: X-BOX kinetic360Group B: Exergaming exercise The volunteers carried out 36 exergaming sessions |
| Group C | Experimental | Dietary Supplement: mediterranean dietGroup C: Mediterranean diet participants participated in the Mediterranean diet intervention for 12 weak and received dietary training from professional nutritionists at the baseline visit and samples of a Mediterranean diet for three times during the trial. |
| Group D | Experimental | Device: X-BOX kinetic360, Dietary Supplement: mediterranean dietGroup D: Exergaming exercises and Mediterranean diet Exergaming exercises are used in addition to Mediterranean diet |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Diagnosis of thyroid papillary carcinoma as it is the most common type
- Treatment with thyroid hormone medication after thyroidectomy
- Lack of radioactive iodine treatment within the past 6 months
- Blood hemoglobin level >10 g/dL.
- Not taking drugs that could affect their immune function (e.g., immunosuppressants such as cyclosporin and steroids .
Key exclusion criteria (2 listed)
- 1) Abscess or inflammation suspected by preoperative tests 2) Patients with stage IV cancer and with limited understanding of assessment systems 3) History of head or neck malignancy . 4) Radiation therapy 5) Graves disease 6) Thyroiditis 7) Orthopaedic and rheumatic conditions of the neck . 8) The patient's inability to cooperate
- -
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 |
|---|---|---|
| X-BOX kinetic360Also: thyroid hormone replacement therapy1) Exergaming The practice of exergaming was performed using the Xbox 360 Kinect console,The volunteers carried out 36 exergaming sessions, with progressive increase in the duration of the games according to their tolerance,and reached a maximum duration of 50 minutes per session, included the realization of the games and the rest between activities. The exergaming protocol was performed two to three times a week, for a total of 12 weeks. | Device | Group B, Group D |
| mediterranean dietAlso: thyroid hormone replacement therapyMediterranean diet participants participated in the Mediterranean diet intervention for 12 weak and received dietary training from professional nutritionists at the baseline visit and samples of a Mediterranean diet for three times during the trial. | Dietary supplement | Group C, Group D |
| thyroid hormone replacement therapythyroid hormone replacement therapy | Drug | Group A |
Primary outcome
CD3-
Time frame: 3 months
CD3 (cluster of differentiation 3) is a protein complex and T cell co-receptor that is involved in activating both the cytotoxic T cell (CD8+ naive T cells) and T helper cells (CD4+ naive T cells). It is composed of four distinct chains. blood sample taken from the patients
CD16+
Time frame: 3 months
CD16 is involved in antibody-dependent cell-mediated cytotoxicity and is expressed on large granular lymphocytes (LGLs) of both NK- and T-cell types.blood sample taken from the patients
CD56+
Time frame: 3 months
CD56, is a member of the immunoglobulin superfamily engaged in both so-called homophilic and heterophilic interactions.blood sample taken from the patients
5 secondary outcomes
TSH(thyroid stimulating hormone)
Time frame: 3 months
T3 (triiodothyronine)
Time frame: 3 months
T4 (Thyroxine)
Time frame: 3 months
Quality of life questionnaire
Time frame: 3 months
Fatigue questionnaire
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Yes. I will share my data
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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.
Mohsen Elsayyad, PhD study director
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing X-BOX kinetic360, mediterranean diet and thyroid hormone replacement therapy in people with Thyroid Cancer, run by Nabil Mahmoud Ismail Abdel-Aal at 1 site in Egypt.
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 2 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: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD3- (time frame: 3 months). The study lists 3 primary outcomes in all. 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 1 May 2026.