Neck Lymph Node DissectionNCT06762886
Aerobic Exercises Versus Laser Puncture on Immune Response Following Neck Lymph Node Dissection
A study testing Cycle ergometer and Low-level laser therapy in people with Neck Lymph Node Dissection and Immune Defects, run by Cairo University at 1 site in Egypt.
Trial summary
Group (1): Twenty cases with decreased white blood cell counts after neck lymph nodes and deficient in blood immunological functions made up this group. They underwent aerobic exercise training on a cycle ergometer. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Neck Lymph Node Dissection, Immune Defects
- What is being tested?
- Cycle ergometer and Low-level laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2022to 15 Feb 2023
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All cases were checked carefully by a physician before the study procedures. All cases were approximately the same age.
- All cases were conscious. All cases in both groups obtained the same medications and they received three sessions per week for 2 months.
- All patients enrolled in the study had a deficiency in blood immune functions post neck lymph node dissection and received chemotherapy.
Who cannot join
- Patients with associated disease (other pathological conditions). patients suffering from metastases. patients taking medications that alter leukocytes count and pregnancy or epilepsy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aerobic Exercises Versus Laser Puncture Therapy on Immune Response Following Neck Lymph Node Dissection
Group (1): Twenty cases with decreased white blood cell counts after neck lymph nodes and deficient in blood immunological functions made up this group. They underwent aerobic exercise training on a cycle ergometer. The cases received one 15-minute session, three sessions per week, for two months, with follow-up after the course of treatment.
Group (2): Twenty cases with underdeveloped blood immune systems; decreased white blood cell counts after having their neck lymph nodes removed, a low-level laser puncture was performed on the Governing Vessel 14 acupuncture point. They received a 15-minute session, three sessions per week, for two months, with follow-up after the course of treatment
Read the detailed description
Inclusion criteria:
All cases were checked carefully by a physician before the study procedures. All cases were approximately the same age. All cases were conscious. All cases in both groups obtained the same medications and they received three sessions per week for 2 months. All patients enrolled in the study had a deficiency in blood immune functions post neck lymph node dissection and received chemotherapy.
Exclusion criteria:
Patients with associated disease (other pathological conditions), patients suffering from metastases, patients taking medications that alter leukocytes count and pregnancy or epilepsy.
Measurement procedures:
The total number of circulating leukocytes (white blood cells) and the differential lymphocyte count were adopted in the current academic work to measure the immunological response in both groups. These were carried out two months after the start of treatment and before the first session: pre-treatment application and post-treatment after two months. The measurement steps were as follows:
Measurement of immune response:
The cases were seated when immune response was measured. Morning peripheral blood sample aspiration was followed by venous blood collection into sterile glass containers with the necessary anticoagulants and preservatives. A Coulter hematology analyzer (Coulter Electronics, USA) was used to perform differential counts of lymphocytes and the total leukocyte count.
Treatment procedures: The following steps were adopted to complete the treatment procedures: When a patient comes in for treatment, they were given a thorough explanation of the procedures' goals as well as their physiological and therapeutic advantages.
Cycle ergometer treatment protocol (Group 1):
The case was lying back in a comfortable position on the stationary bike ergometer when the exercise test was conducted. The exercise test began with a 3-minute warm-up session of unloaded cycling on a cycle ergometer, and then progressed at a rate of 10 W per minute up to the subject's threshold. After cycling for 30 W to warm up, the intensity was raised by 15 W every 60 seconds until fatigue, after which the individuals cycled for 30 W to cool down. This treatment protocol was administered to each patient 3 times/week for a total of 15 minutes of treatment, broken into intervals of two to three minutes each.
Low-level laser treatment protocol (Group 2):
The laser probe was administered using the contact approach on the dorsal midline, in the depression below the spinous process of C7 at Governor Vessel, with the patient seated in a chair with back support (GV - 14 Dazhui). The primary power switch was activated. The following settings were used for applying laser puncture: 5 mW, the maximum average power. Type of laser: gallium arsenide (Ga-As), 904 nm wavelength, 5 kHz maximum repetition rate - Program: Maintaining programs for people who had their neck lymph nodes removed and have a low leukocyte count, up to 30 J/cm2 of energy, a 2 J/cm2 energy density, and protective glasses were required to prevent irreversible eye injury from either direct or indirect laser exposure. The treatment took place for 15 minutes.
- Conditions
- Neck Lymph Node Dissection, Immune Defects
- Being tested
- Cycle ergometer, Low-level laser therapy
- Keywords
- Aerobic Exercises, Laser Puncture Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycle ergometerDevice
The case was lying back in a comfortable position on the stationary bike ergometer when the exercise test was conducted. The exercise test began with a 3-minute warm-up session of unloaded cycling on a cycle ergometer, and then progressed at a rate of 10 W per minute up to the subject's threshold. After cycling for 30 W to warm up, the intensity was raised by 15 W every 60 seconds until fatigue, after which the individuals cycled for 30 W to cool down. This treatment protocol was administered to each patient 3 times/week for a total of 15 minutes of treatment, broken into intervals of two to three minutes each.
Low-level laser therapyDevice
The laser probe was administered using the contact approach on the dorsal midline, in the depression below the spinous process of C7 at Governor Vessel, with the patient seated in a chair with back support (GV - 14 Dazhui). The primary power switch was activated. The following settings were used for applying laser puncture: 5 mW, the maximum average power. Type of laser: gallium arsenide (Ga-As), 904 nm wavelength, 5 kHz maximum repetition rate - Program: Maintaining programs for people who had their neck lymph nodes removed and have a low leukocyte count, up to 30 J/cm2 of energy, a 2 J/cm2 energy density, and protective glasses were required to prevent irreversible eye injury from either direct or indirect laser exposure. The treatment took place for 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Cycle ergometer treatment protocol (Group 1): | Experimental | Twenty cases with decreased white blood cell counts after neck lymph nodes and deficient in blood immunological functions made up this group. They underwent aerobic exercise training on a cycle ergometer. The cases received one 15-minute session, three sessions per week, for two months, with follow-up after the course of treatment Receives: Device: Cycle ergometer |
| Low-level laser treatment protocol (Group 2): | Experimental | Twenty cases with underdeveloped blood immune systems; decreased white blood cell counts after having their neck lymph nodes removed, a low-level laser puncture was performed on the Governing Vessel 14 acupuncture point. They received a 15-minute session, three sessions per week, for two months, with follow-up after the course of treatment Receives: Device: Low-level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leukocyte total count and differential lymphocyte count measurements
Measurement of immune response:
The cases were seated when immune response was measured. Morning peripheral blood sample aspiration was followed by venous blood collection into sterile glass containers with the necessary anticoagulants and preservatives. A Coulter hematology analyzer (Coulter Electronics, USA) was used to perform differential counts of lymphocytes and the total leukocyte count.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start15 Oct 2022
- Primary completion15 Dec 2022
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck Lymph Node DissectionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Model description
- Cycle ergometer treatment protocol (Group 1): The case was lying back in a comfortable position on the stationary bike ergometer when the exercise test was conducted. The exercise test began with a 3-minute warm-up session of unloaded cycling on a cycle ergometer, and then progressed at a rate of 10 W per minute up to the subject's threshold. After cycling for 30 W to warm up, the intensity was raised by 15 W every 60 seconds until fatigue, after which the individuals cycled for 30 W to cool down. This treatment protocol was administered to each patient 3 times/week for a total of 15 minutes of treatment, broken into intervals of two to three minutes each. Low-level laser treatment protocol (Group 2): The laser probe was administered using the contact approach on the dorsal midline, in the depression below the spinous process of C7 at Governor Vessel, with the patient seated in a chair with back support (GV - 14 Dazhui). The primary power switch was activated. The following set
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Gamal Fawzy El-Sayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762886
- Sponsor's protocol ID
- P.T.REC/012/004069
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2025
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Exercises Versus Laser Puncture Therapy on Immune Response Following Neck Lymph Node Dissection
- ClinicalTrials.gov ID
- NCT06762886
- Acronym / sponsor ID
- P.T.REC/012/004069
- Conditions
- Neck Lymph Node Dissection, Immune Defects
- Keywords
- Aerobic Exercises, Laser Puncture Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 8 Jan 2025 (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.
Group (1): Twenty cases with decreased white blood cell counts after neck lymph nodes and deficient in blood immunological functions made up this group. They underwent aerobic exercise training on a cycle ergometer. The cases received one 15-minute session, three sessions per week, for two months, with follow-up after the course of treatment.
Group (2): Twenty cases with underdeveloped blood immune systems; decreased white blood cell counts after having their neck lymph nodes removed, a low-level laser puncture was performed on the Governing Vessel 14 acupuncture point. They received a 15-minute session, three sessions per week, for two months, with follow-up after the course of treatment
Detailed description
Inclusion criteria:
All cases were checked carefully by a physician before the study procedures. All cases were approximately the same age. All cases were conscious. All cases in both groups obtained the same medications and they received three sessions per week for 2 months. All patients enrolled in the study had a deficiency in blood immune functions post neck lymph node dissection and received chemotherapy.
Exclusion criteria:
Patients with associated disease (other pathological conditions), patients suffering from metastases, patients taking medications that alter leukocytes count and pregnancy or epilepsy.
Measurement procedures:
The total number of circulating leukocytes (white blood cells) and the differential lymphocyte count were adopted in the current academic work to measure the immunological response in both groups. These were carried out two months after the start of treatment and before the first session: pre-treatment application and post-treatment after two months. The measurement steps were as follows:
Measurement of immune response:
The cases were seated when immune response was measured. Morning peripheral blood sample aspiration was followed by venous blood collection into sterile glass containers with the necessary anticoagulants and preservatives. A Coulter hematology analyzer (Coulter Electronics, USA) was used to perform differential counts of lymphocytes and the total leukocyte count.
Treatment procedures: The following steps were adopted to complete the treatment procedures: When a patient comes in for treatment, they were given a thorough explanation of the procedures' goals as well as their physiological and therapeutic advantages.
Cycle ergometer treatment protocol (Group 1):
The case was lying back in a comfortable position on the stationary bike ergometer when the exercise test was conducted. The exercise test began with a 3-minute warm-up session of unloaded cycling on a cycle ergometer, and then progressed at a rate of 10 W per minute up to the subject's threshold. After cycling for 30 W to warm up, the intensity was raised by 15 W every 60 seconds until fatigue, after which the individuals cycled for 30 W to cool down. This treatment protocol was administered to each patient 3 times/week for a total of 15 minutes of treatment, broken into intervals of two to three minutes each.
Low-level laser treatment protocol (Group 2):
The laser probe was administered using the contact approach on the dorsal midline, in the depression below the spinous process of C7 at Governor Vessel, with the patient seated in a chair with back support (GV - 14 Dazhui). The primary power switch was activated. The following settings were used for applying laser puncture: 5 mW, the maximum average power. Type of laser: gallium arsenide (Ga-As), 904 nm wavelength, 5 kHz maximum repetition rate - Program: Maintaining programs for people who had their neck lymph nodes removed and have a low leukocyte count, up to 30 J/cm2 of energy, a 2 J/cm2 energy density, and protective glasses were required to prevent irreversible eye injury from either direct or indirect laser exposure. The treatment took place for 15 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Cycle ergometer treatment protocol (Group 1): The case was lying back in a comfortable position on the stationary bike ergometer when the exercise test was conducted. The exercise test began with a 3-minute warm-up session of unloaded cycling on a cycle ergometer, and then progressed at a rate of 10 W per minute up to the subject's threshold. After cycling for 30 W to warm up, the intensity was raised by 15 W every 60 seconds until fatigue, after which the individuals cycled for 30 W to cool down. This treatment protocol was administered to each patient 3 times/week for a total of 15 minutes of treatment, broken into intervals of two to three minutes each. Low-level laser treatment protocol (Group 2): The laser probe was administered using the contact approach on the dorsal midline, in the depression below the spinous process of C7 at Governor Vessel, with the patient seated in a chair with back support (GV - 14 Dazhui). The primary power switch was activated. The following set
| Arm | Type | Receives |
|---|---|---|
| Cycle ergometer treatment protocol (Group 1): | Experimental | Device: Cycle ergometerTwenty cases with decreased white blood cell counts after neck lymph nodes and deficient in blood immunological functions made up this group. They underwent aerobic exercise training on a cycle ergometer. The cases received one 15-minute session, three sessions per week, for two months, with follow-up after the course of treatment |
| Low-level laser treatment protocol (Group 2): | Experimental | Device: Low-level laser therapyTwenty cases with underdeveloped blood immune systems; decreased white blood cell counts after having their neck lymph nodes removed, a low-level laser puncture was performed on the Governing Vessel 14 acupuncture point. They received a 15-minute session, three sessions per week, for two months, with follow-up after the course of treatment |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All cases were checked carefully by a physician before the study procedures. All cases were approximately the same age.
- All cases were conscious. All cases in both groups obtained the same medications and they received three sessions per week for 2 months.
- All patients enrolled in the study had a deficiency in blood immune functions post neck lymph node dissection and received chemotherapy.
Key exclusion criteria (1 listed)
- Patients with associated disease (other pathological conditions). patients suffering from metastases. patients taking medications that alter leukocytes count and pregnancy or epilepsy.
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 |
|---|---|---|
| Cycle ergometerThe case was lying back in a comfortable position on the stationary bike ergometer when the exercise test was conducted. The exercise test began with a 3-minute warm-up session of unloaded cycling on a cycle ergometer, and then progressed at a rate of 10 W per minute up to the subject's threshold. After cycling for 30 W to warm up, the intensity was raised by 15 W every 60 seconds until fatigue, after which the individuals cycled for 30 W to cool down. This treatment protocol was administered to each patient 3 times/week for a total of 15 minutes of treatment, broken into intervals of two to three minutes each. | Device | Cycle ergometer treatment protocol (Group 1): |
| Low-level laser therapyThe laser probe was administered using the contact approach on the dorsal midline, in the depression below the spinous process of C7 at Governor Vessel, with the patient seated in a chair with back support (GV - 14 Dazhui). The primary power switch was activated. The following settings were used for applying laser puncture: 5 mW, the maximum average power. Type of laser: gallium arsenide (Ga-As), 904 nm wavelength, 5 kHz maximum repetition rate - Program: Maintaining programs for people who had their neck lymph nodes removed and have a low leukocyte count, up to 30 J/cm2 of energy, a 2 J/cm2 energy density, and protective glasses were required to prevent irreversible eye injury from either direct or indirect laser exposure. The treatment took place for 15 minutes. | Device | Low-level laser treatment protocol (Group 2): |
Primary outcome
Leukocyte total count and differential lymphocyte count measurements
Time frame: 2 months
Measurement of immune response: The cases were seated when immune response was measured. Morning peripheral blood sample aspiration was followed by venous blood collection into sterile glass containers with the necessary anticoagulants and preservatives. A Coulter hematology analyzer (Coulter Electronics, USA) was used to perform differential counts of lymphocytes and the total leukocyte count.
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 8 Jan 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycle ergometer and Low-level laser therapy in people with Neck Lymph Node Dissection and Immune Defects, run by Cairo University 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 3 inclusion and 1 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 8 Jan 2025. 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?
Leukocyte total count and differential lymphocyte count measurements (time frame: 2 months). 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 8 Jan 2025.