Evaluate the Effectiveness of Low Level Laser Therapy (LLT) Combined With Acupuncture

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer
• Intervention / Treatment: Device: B-Cure Laser Pro and needles

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael schlosser; Phone Number: +972-54-4777307; Email: Michael@gd-energis.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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

   1. failed standard treatment for their type of cancer
   2. decline standard treatment and interested in non-invasive treatment or change in life style
   3. have time to decide on treatment options and interested in non-invasive treatment
2. Confirm cancer diagnosis using biopsy, biomarkers or imaging (PET/CT, MRI, CT, Ultrasound, etc.)
3. Karnofsky performance status score of at least 60% for lung cancer and at least 50% for all other cancers at the screening visit
4. Life expectancy of at least 12 weeks

5. Patients must have adequate organ function as defined below:

   1. AST (SGOT)/ALT(SGPT) <3x upper limit of normal (ULN).
   2. Serum creatinine <2.0 mg/dL.
   3. Serum bilirubin <3 mg/dL
6. Signed written informed consent to participate in the study independently by patient.
7. Ability to comply with the requirements of the study.

Exclusion Criteria:

1. Participation in an interventional investigational trial within 30 days of the screening visit.
2. Receipt of chemotherapy or radiotherapy within 1 month of the screening visits
3. 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).
4. 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.
5. who are likely to be non-compliant or uncooperative during the study. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: B-Cure Laser Pro and needles; 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.

Device: B-Cure Laser Pro and needles; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported pain perception using SF-MPQ	After treatment pain perception will be measured by using Self-reported pain perception using SF-MPQ	3 months
Self-reported pain perception using pain diagram	After treatment pain perception be measured by using pain diagram	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Outcome - Adverse events related to Investigational therapy	Adverse events related to Investigational therapy	3 months

Collaborators and Investigators

• Sponsor: Erika Carmel ltd
• Investigators: Principal Investigator: Ido Wolf, MD, head of Medical Oncology Unit Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: February 9, 2016
• First Submitted That Met QC Criteria: February 15, 2016
• First Posted (Estimate): February 19, 2016

Study Record Updates

• Last Update Posted (Actual): December 14, 2021
• Last Update Submitted That Met QC Criteria: December 13, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: GD-IP-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No