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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.
Full 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.
Enrollment
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Volunteers
Inclusion criteria
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:
Signed written informed consent to participate in the study independently by patient.
Ability to comply with the requirements of the study.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
30 participants in 1 patient group
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Central trial contact
Michael schlosser
Data sourced from clinicaltrials.gov
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