VGAIT for Chemotherapy-induced Peripheral Neuropathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorMassachusetts General Hospital
About this trial
Perform a feasibility study on imagined acupuncture treatment of Chemotherapy-induced peripheral neuropathy (CIPN)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
at least 18 years of age
have histologically confirmed stage I-III breast cancer,
have completed adjuvant taxane-based chemotherapy (alone or in combination), ,
have an Eastern Cooperative Oncology Group performance status of 0 or 1, and reported grade 1 or greater CIPN symptoms for more than 2 weeks as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
Disqualifiers
concurrent chemotherapy (there were no limitations on time from the last paclitaxel administration),
having metastatic or recurrent disease,
history of preexisting peripheral neuropathy prior to chemotherapy,
uncontrolled seizure disorder,
Trial design
Design model
Single group
Treatments tested in this trial
Video-Guided Acupuncture Imagery Treatment (VGAIT)
Other interventionParticipants watch a video of acupuncture being applied to the body while simultaneously imagining that it is being administered to them
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: VGAITExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility related outcomes
Completion, satisfaction
Time frame
8 weekSecondary outcomes
1
Patient Neurotoxicity Questionnaire (PNQ)
A tool designed to assess neurotoxic effects in patients who have undergone treatments such as chemotherapy
Time frame
baseline, 8 week2
Functional Assessment of Cancer Therapy-Neurotoxicity subscale (FACT-NTX)
a widely used, validated instrument that assesses the impact of neuropathy on health-related quality of life
Time frame
baseline, 8 week3
Brief Pain Inventory-short form (BPI-SF)
An instrument used to evaluate the severity of pain, including neuropathic pain, and the impact on the patient's daily functioning.
Time frame
baseline, 8 week4
European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (QLQ-C30) instrument
an instrument developed to assess the quality of life in cancer patients
Time frame
baseline, 8 weekSponsors and contacts
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Source ClinicalTrials.gov