CancerNCT02686203
Evaluate the Effectiveness of Low Level Laser Therapy (LLT) Combined With Acupuncture
A study testing B-Cure Laser Pro and needles in people with Cancer, run by Erika Carmel ltd.
Trial summary
evaluating The Investigational Therapy effects on quality of life, pain and patient's clinical status in adult cancer patients with solid tumors who are no longer candidates for active oncological therapies. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cancer
- What is being tested?
- B-Cure Laser Pro and needles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2021to Dec 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients 18 to 70 years of age diagnosed with cancer (with or without metastasis) including but not limited to breast, ovarian, cervical, uterine, renal, bladder, gastric, pancreas, lung, thyroid, colorectal, small and large intestine, testicle and prostate cancer who have either
- failed standard treatment for their type of cancer
- decline standard treatment and interested in non-invasive treatment or change in life style
- have time to decide on treatment options and interested in non-invasive treatment
- Confirm cancer diagnosis using biopsy, biomarkers or imaging (PET/CT, MRI, CT, Ultrasound, etc.)
- Karnofsky performance status score of at least 60% for lung cancer and at least 50% for all other cancers at the screening visit
Show all 13Show fewer
- Life expectancy of at least 12 weeks
- Patients must have adequate organ function as defined below:
- AST (SGOT)/ALT(SGPT) <3x upper limit of normal (ULN).
- Serum creatinine <2.0 mg/dL.
- Serum bilirubin <3 mg/dL
- Signed written informed consent to participate in the study independently by patient.
- Ability to comply with the requirements of the study.
Who cannot join
- Participation in an interventional investigational trial within 30 days of the screening visit.
- Receipt of chemotherapy or radiotherapy within 1 month of the screening visits
- Patients with other concurrent severe and/or uncontrolled medical condition which could compromise participation in the study or interfere with the evaluation of the investigational therapy effect (i.e. active infection, uncontrolled diabetes, uncontrolled hypertension, congestive cardiac failure, unstable angina, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper gastrointestinal tract ulceration).
- Any form of substance abuse (including drug or alcohol abuse), psychiatric disorder or any chronic condition susceptible, in the opinion of the investigator or the sponsor, of interfering with the conduct of the study.
- who are likely to be non-compliant or uncooperative during the study. -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Feasibility Study to Evaluate the Effectiveness of Low Level Laser Therapy Combined With Acupuncture as Palliative Treatment of Patients With Various Solid Malignancies Who Are no Longer Candidates for Active Oncological Therapies
evaluating The Investigational Therapy effects on quality of life, pain and patient's clinical status in adult cancer patients with solid tumors who are no longer candidates for active oncological therapies.
Read the detailed description
evaluating The Investigational Therapy effects on quality of life, pain and patient's clinical status in adult cancer patients with solid tumors who are no longer candidates for active oncological therapies.
Eligible patients will be enrolled into the study and receive at least two 20-min treatment sessions, 2 to 12 weeks apart, with the Investigational Therapy on healthy body tissue (i.e. non-tumor region) of back of the hand and/or foot. Number of treatment sessions and treatment frequency will be individualized per patient depending on patient's status as well as per the discretion of the treating therapist, who is specialized and experienced with using the Investigational Therapy. Patients will be assessed for quality of life, pain and patient's clinical status according to acceptable clinical evaluations.
If at any time after the start of this study, it will be decided to initiate active oncological treatment, the principal investigator or designee will inform the Sponsor. The Sponsor will decide if the patient will stay or be discontinued from the study.
- Conditions
- Cancer
- Being tested
- B-Cure Laser Pro and needles
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-Cure Laser Pro and needlesDevice
Treatment will consist of acupuncture applied by a combination of B-Cure Laser Pro, an approved handheld, portable device emitting low level laser, and needles using two to four acupoints (The Investigational Therapy).
The Investigational Therapy will be administered by a treating therapist designated by the Sponsor who is experienced in employing the treatment
| Study group | Role | What they receive |
|---|---|---|
| B-Cure Laser Pro and needles | Experimental | Treatment will consist of acupuncture applied by a combination of B-Cure Laser Pro, an approved handheld, portable device emitting low level laser, and needles using two to four acupoints (The Investigational Therapy).
The Investigational Therapy will be administered by a treating therapist designated by the Sponsor who is experienced in employing the treatment. Receives: Device: B-Cure Laser Pro and needles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life using World Health Organization Quality of Life questionnaire (WHOQoL-BREF)
After treatment Quality of life will be measured by using World Health Organization Quality of Life questionnaire (WHOQoL-BREF)
Measured: 3 months
Quality of life using patient questionnaire Karnofsky performance status
After treatment Quality of life will be measured by using patient questionnaire Karnofsky performance status
Measured: 3 months
Secondary outcomes (2)
Self-reported pain perception using SF-MPQ
After treatment pain perception will be measured by using Self-reported pain perception using SF-MPQ
Measured: 3 months
Self-reported pain perception using pain diagram
After treatment pain perception be measured by using pain diagram
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 posted19 Feb 2016 (estimated)
- Study startDec 2021 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erika Carmel ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ido Wolf, MD, Principal investigator, head of Medical Oncology Unit Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686203
- Sponsor's protocol ID
- GD-IP-101
- Status last verified
- Nov 2021
- First submitted
- 9 Feb 2016
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Evaluate the Effectiveness of Low Level Laser Therapy Combined With Acupuncture as Palliative Treatment of Patients With Various Solid Malignancies Who Are no Longer Candidates for Active Oncological Therapies
- ClinicalTrials.gov ID
- NCT02686203
- Acronym / sponsor ID
- GD-IP-101
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Erika Carmel ltdUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 19 Feb 2016 (estimated)
- 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.
evaluating The Investigational Therapy effects on quality of life, pain and patient's clinical status in adult cancer patients with solid tumors who are no longer candidates for active oncological therapies.
Detailed description
evaluating The Investigational Therapy effects on quality of life, pain and patient's clinical status in adult cancer patients with solid tumors who are no longer candidates for active oncological therapies.
Eligible patients will be enrolled into the study and receive at least two 20-min treatment sessions, 2 to 12 weeks apart, with the Investigational Therapy on healthy body tissue (i.e. non-tumor region) of back of the hand and/or foot. Number of treatment sessions and treatment frequency will be individualized per patient depending on patient's status as well as per the discretion of the treating therapist, who is specialized and experienced with using the Investigational Therapy. Patients will be assessed for quality of life, pain and patient's clinical status according to acceptable clinical evaluations.
If at any time after the start of this study, it will be decided to initiate active oncological treatment, the principal investigator or designee will inform the Sponsor. The Sponsor will decide if the patient will stay or be discontinued from the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| B-Cure Laser Pro and needles | Experimental | Device: B-Cure Laser Pro and needlesTreatment will consist of acupuncture applied by a combination of B-Cure Laser Pro, an approved handheld, portable device emitting low level laser, and needles using two to four acupoints (The Investigational Therapy). The Investigational Therapy will be administered by a treating therapist designated by the Sponsor who is experienced in employing the treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male and female patients 18 to 70 years of age diagnosed with cancer (with or without metastasis) including but not limited to breast, ovarian, cervical, uterine, renal, bladder, gastric, pancreas, lung, thyroid, colorectal, small and large intestine, testicle and prostate cancer who have either
- Confirm cancer diagnosis using biopsy, biomarkers or imaging (PET/CT, MRI, CT, Ultrasound, etc.)
- Karnofsky performance status score of at least 60% for lung cancer and at least 50% for all other cancers at the screening visit
- Life expectancy of at least 12 weeks
- Patients must have adequate organ function as defined below:
Key exclusion criteria (5 listed)
- Participation in an interventional investigational trial within 30 days of the screening visit.
- Receipt of chemotherapy or radiotherapy within 1 month of the screening visits
- Patients with other concurrent severe and/or uncontrolled medical condition which could compromise participation in the study or interfere with the evaluation of the investigational therapy effect (i.e. active infection, uncontrolled diabetes, uncontrolled hypertension, congestive cardiac failure, unstable angina, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper gastrointestinal tract ulceration).
- Any form of substance abuse (including drug or alcohol abuse), psychiatric disorder or any chronic condition susceptible, in the opinion of the investigator or the sponsor, of interfering with the conduct of the study.
- who are likely to be non-compliant or uncooperative during the study. -
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 |
|---|---|---|
| B-Cure Laser Pro and needlesTreatment will consist of acupuncture applied by a combination of B-Cure Laser Pro, an approved handheld, portable device emitting low level laser, and needles using two to four acupoints (The Investigational Therapy). The Investigational Therapy will be administered by a treating therapist designated by the Sponsor who is experienced in employing the treatment | Device | B-Cure Laser Pro and needles |
Primary outcome
Quality of life using World Health Organization Quality of Life questionnaire (WHOQoL-BREF)
Time frame: 3 months
After treatment Quality of life will be measured by using World Health Organization Quality of Life questionnaire (WHOQoL-BREF)
Quality of life using patient questionnaire Karnofsky performance status
Time frame: 3 months
After treatment Quality of life will be measured by using patient questionnaire Karnofsky performance status
2 secondary outcomes
Self-reported pain perception using SF-MPQ
Time frame: 3 months
Self-reported pain perception using pain diagram
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- 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.
Ido Wolf, MD principal investigator
head of Medical Oncology Unit Sourasky Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing B-Cure Laser Pro and needles in people with Cancer, run by Erika Carmel ltd.
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 13 inclusion and 5 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 14 Dec 2021. 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.
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 Michael schlosser (+972-54-4777307, Michael@gd-energis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life using World Health Organization Quality of Life questionnaire (WHOQoL-BREF) (time frame: 3 months). The study lists 2 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 14 Dec 2021.