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

NCT02686203 | Unknown

• 1 other identifier: GD-IP-101
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Self-reported pain perception using SF-MPQ

  3 months

• Self-reported pain perception using pain diagram

  3 months

Other Outcomes (1)

• Safety Outcome - Adverse events related to Investigational therapy

  3 months

Study Arms (1)

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.

Device: B-Cure Laser Pro and needles

Interventions

B-Cure Laser Pro and needles DEVICE

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

B-Cure Laser Pro and needles

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Erika Carmel ltd: lead

MeSH Terms

Conditions

Neoplasms

Interventions

Needles

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Ido Wolf, MD

  head of Medical Oncology Unit Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael schlosser

CONTACT

+972-54-4777307; Michael@gd-energis.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: February 19, 2016
• Study Start: December 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: December 14, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share