NCT02686203

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Erika Carmel ltd · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2016-02-19
• Last updated: 2021-12-14