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.
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
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
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
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)
Time frame: 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
Time frame: 3 months
Self-reported pain perception using SF-MPQ
After treatment pain perception will be measured by using Self-reported pain perception using SF-MPQ
Time frame: 3 months
Self-reported pain perception using pain diagram
After treatment pain perception be measured by using pain diagram
Time frame: 3 months
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