Participants will be given two beverages, (isomaltulose or sucrose) in a random order (one of each on each of the two test dates).

Chronic Pain

Participants will be given test beverages containing 50gr of isomaltulose (low glycemic index = 32). Isomaltulose powder will be dissolved in 250mL water, and participants will be instructed to consume this beverage within 5 minutes. Blood glucose levels will be collected at 15, 30, 45, 60, 90, and 120 minutes after consumption of the beverages. The first two drops of blood will be discarded, the third drop will be used for testing.

Low glycemic load

Participants will be given test beverages containing 50gr sucrose (high glycemic index = 65). Sucrose powder will be dissolved in 250mL water, and participants will be instructed to consume this beverage within 5 minutes. Blood glucose levels will be collected at 15, 30, 45, 60, 90, and 120 minutes after consumption of the beverages. The first two drops of blood will be discarded, the third drop will be used for testing.

High glycemic load

Vrije Universiteit Brussel

KU Leuven

Pain, Nutrition and Glycemic Response in Chronic Low Back Pain and Breast Cancer Survivors

The Association Between Pain, Nutrition and Glycemic Response in Chronic Low Back Pain and Breast Cancer Survivors: a Cross-over Trial.

Blood glucose levels will be measured using OneTouch Verio (LifeScan Europe, Johnson & Johnson, Switzerland). Blood glucose levels will be collected at 15, 30, 45, 60, 90, and 120 minutes after consumption of the beverages.

The "Brief Pain Inventory" allows to rate the worst pain in the last 24 hours, the least pain in the last 24 hours, the average pain and the pain intensity at the moment of filling out the questionnaire. This tool also assesses the interference of pain with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep via an 11-point numeric rating pain scale, ranging from 0 (no pain) to 10 (worst pain).

The "Central Sensitization Inventory" assesses symptoms that can indicate central sensitization mechanisms. It includes two sections, Part A and Part B, which can be used independently from each other. In this study, only Part A will be used, which includes 25 questions scored on a Likert Scale ranging from 0 (i.e. never) to 4 (i.e. always). Summing these scores, a total score between 0 and 100 is obtained. The CSI showed a cut-off of 40 to indicate the possible presence of central sensitization.

The "Douleur Neuropathique 4 Questionnaire" is a screening tool for neuropathic pain. It consists of four main questions, which all include 10 sub-questions. Each of these subquestions can be answered with YES (1 point) or NO (0 points). Scores which are equal or higher to 4 out of 10 indicate the possible presence of neuropathic problems that underly the pain problem.

Electrical detection thresholds will be measured using the Surpass LT stimulator (EMS Biomedical, Korneuburg, Austria) at the bilateral sural nerve, and at the bilateral median nerve (i.e. four test sites). Each stimulus will be a constant current rectangular pulse train consisting of 5 pulses delivered at a frequency of 250 Hertz. Stimulation will start at 0 milli amper and will be gradually increased using steps of 0.5 milli amper until the patient is experiencing a faint sensation.

Electrical pain thresholds will be measured using the Surpass LT stimulator (EMS Biomedical, Korneuburg, Austria) at the bilateral sural nerve, and at the bilateral median nerve (i.e. four test sites). Each stimulus will be a constant current rectangular pulse train consisting of 5 pulses delivered at a frequency of 250 Hertz. Stimulation will start at 0 milli amper and will be gradually increased using steps of 0.5 milli amper until the stimulus is experienced as painful.

Electrical temporal summation will be measured using the Surpass LT stimulator (EMS Biomedical, Korneuburg, Austria). Temporal summation will be assessed by delivering 20 electrical stimuli at the previously determined intensity of the electrical pain threshold. The patient will be asked to give a verbal numeric rating scale score ranging from 0 (= no pain) to 100 (= worst possible pain) at the 1st, the 10th and the 20th stimulus. The outcome measures for temporal summation will be the differences between the 10th and 1st pain score, the 20th and 10th pain score and 20th and 1st pain score.

Electrical offset analgesia will be measured using the Surpass LT stimulator (EMS Biomedical, Korneuburg, Austria). Electrical stimuli will be applied as a train of rectangular pulses delivered by a constant current stimulator. The stimulation intensity will be calculated using the electrical pain threshold. The study participants will be given the painful stimuli into three times intervals and using three intensities; T1 (5 seconds at 150% of Electrical pain threshold), T2 (5 second at 180% of Electrical Pain threshold) and T3 (20 seconds at 150% Electrical pain threshold). Afterwards, participants will undergo a control electrical stimulus which encompasses 30 seconds of constant electrical stimulation at 150% of the Electrical pain threshold. During each application (control trial, T1, T2, and T3) participants need to report their intensity of pain on a visual analogue scale. The scale is anchored by "no pain"(score of 0) and "worst imaginable pain" (score of 100).

Pressure pain thresholds measure hyperalgesia by means of a digital pressure algometer (Wagner Instruments, Greenwich) with a 1 centimetre square tip. Pressure will be increased at a rate of 1 kilogram per second. Subjects need to say "stop" when the pressure is experienced as painful.

The diary asks for dietary intake information of two weekdays and one day in the weekend. Collected data with the 3-day food diary will allow us to find out approximate calorie intake, micronutrient intake, macronutrient intake of each participant.

Collected data with the 3-day food diary will allow us to calculate the Healthy Eating Index. The "Healthy Eating Index" consists of thirteen items of which nine items (total fruit, whole fruit, vegetables, greens and beans, whole grains, dairy, total protein foods, seafood and plant proteins, fatty acids) are recommended to consume, while the consumption of the other four items (refined grains, sodium, added sugars, saturated fats) should be as low as possible in order to achieve a healthy diet. Score for the Healthy Eating Index range from 0 to 100. Higher scores represent healthier diets

A nine-point score of the Mediterranean Diet Score can be calculated using gender-specific medians of intake. A value above the median is rated 1, below the median 0. Higher scores represent healthier diets.

"Short Form-36" contains 36 questions across 7 subscales, namely, "general health", "limitations of activities", "physical health problems", "emotional health problems", "social activities", "pain" and "energy and emotions". Each domain ranked between 0 to 100. Higher scores indicates better.

The "International Physical Activity Questionnaire" consists of 5 main domains (1-job-related physical activity; 2-transportation related physical activity; 3-housework, house maintenance, and caring for family-related physical activity; 4-recreation, sports, and leisure-time physical activity; and 5-time spent sitting) with 27 context-specific physical activity questions. Higher scores indicates better.

"TANITA MC-780MA" bio electrical impedance analysis will be used to analyse the body weight in kilograms and body weight percentage.

"TANITA MC-780MA" bio electrical impedance analysis will be used to analyse the body fat mass in kilograms and body fat mass percentage.

"TANITA MC-780MA" bio electrical impedance analysis will be used to analyse the body muscle mass in kilograms and body muscle mass percentage.

"TANITA MC-780MA" bio electrical impedance analysis will be used to analyse the body water in kilograms and body water percentage.

Body height in meters will be measured using a Seca length meter.

Body weight and height will be combined to report body mass index in kilogram per meter squared.

The Investigator and the Participating Site shall treat all information and data relating to the Study disclosed to Participating Site and/or Investigator in this Study as confidential and shall not disclose such information to any third parties or use such information for any purpose other than the performance of the Study. The collection, processing and disclosure of personal data, such as patient health and medical information is subject to compliance with applicable personal data protection and the processing of personal data (Directive 95/46/EC and Belgian law of December 8, 1992 on the Protection of the Privacy in relation to the Processing of Personal Data).
Data are anonymous if no one, not even the researcher, can connect the data to the individual who provided it. No identifying information is collected from the individual.

Malfliet Anneleen

Principal Investigator

As part of routine clinical care, a chemotherapy nurse, research nurse, or physician will assess the patient's symptoms including CIPN based on the NCI-CTC 4.0 criteria to determine the grade of CIPN. Once these patients develop National Cancer Institute-Common Toxicity Criteria (NCI-CTC) grade 2 CIPN, they will be recruited for the intervention phase of the study. Severity of CIPN as defined by NCI-CTC is listed in Appendix A. Patients who consent to the intervention phase of the study will then be treated with weekly acupuncture until the end of chemotherapy. No concomitant anti-neuropathy medication will be permitted.
Subjects will receive acupuncture in bilateral ear points: shen men, point zero, two additional auricular acupuncture point where electrodermal signal is detected and bilateral body acupuncture points: LI4, TE5, LI11, ST40, Ba Feng, Ba xie.

Breast Cancer

Peripheral Neuropathy

Each treatment session will be approximately 40 minutes in duration, 10 minutes to insert needles, 30 minutes to leave needles in. Patients will receive one acupuncture treatment each week until the end of chemotherapy. Adverse effects related to the administration of acupuncture will be collected each week before and after each treatment by the acupuncturist or research study assistant. All Integrative Medicine Service acupuncturists are licensed, credentialed employees of MSK.

Acupuncture

It will be collected weekly throughout the screening phase, as well as, at the time of intervention consent, weekly during the intervention, and then once again after the last acupuncture session before the last chemotherapy session.

Neuropathic Pain Scale (NPS) questionnaire

It will be collected weekly throughout the screening phase, as well as, at the time of intervention consent, weekly during the intervention, and then once again after the last acupuncture session but before the as the last chemotherapy session, and then once again 3 months (+/-2 weeks) after chemotherapy completion.

FACT/GOG-Ntx questionnaire

Memorial Sloan Kettering Westchester

Memorial Sloan Kettering Cancer Center

Acupuncture to Reduce Chemotherapy-induced Peripheral Neuropathy Severity During Neoadjuvant or Adjuvant Weekly Paclitaxel Chemotherapy in Breast Cancer Patients

Acupuncture to Reduce Chemotherapy-induced Peripheral Neuropathy Severity During Neoadjuvant or Adjuvant Weekly Paclitaxel Chemotherapy in Breast Cancer Patients: A Pilot Study

After the initiation of acupuncture through the end of chemotherapy in breast cancer patients undergoing neoadjuvant or adjuvant weekly paclitaxel chemotherapy when compared to historical control ECOG study 1199 [1] weekly paclitaxel treatment arm. The efficacy of acupuncture in reducing CIPN severity and preventing progression of grade 2 CIPN to grade 3 or higher.

Validated patient-reported outcome questionnaires: Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaire, the Neuropathy Pain Scale (NPS) and the vibration sensation test will be assessed at the time of intervention consent and then after the last acupuncture session on the same day of the last chemotherapy. CIPN grade per NCI-CTC 4.0 will be assessed weekly and then once again at 3 months (+/-2 weeks) after chemotherapy completion .

Duloxetine 30 mg daily x 1 week, then 60 mg daily x 4 weeks, then 30 mg daily x 2 weeks.

Patient reported pain and symptoms assessment for comparison at baseline.

Duloxetine 30 mg daily x 1 week, then 60 mg daily x 4 weeks, then 30 mg daily x 2 weeks.
Duloxetine: Subjects will receive 30 mg duloxetine orally for 7 days, then 60 mg duloxetine orally for 28 days, then 30 mg duloxetine orally x 14 days.

Arm 1 (Patients With Pain)

Arm 2 (Patients Without Pain -- Control)

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Worst pain will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory.
Baseline: Mean worst pain for all individual patients in arm 1 (intervention) and arm 2 (control)
5 weeks: Mean worst pain for all individual patients in arm 1 (intervention)
Range of pain score 0-10 (0=no pain; 10=worst pain)

Change in Patient-reported Worst Pain Between Baseline and 5 Weeks of Treatment With Duloxetine

Average pain will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory.
Baseline: Mean average pain for all individual patients in arm 1 (intervention) and arm 2 (control)
5 weeks: Mean average pain for all individual patients in arm 1 (intervention)
Range of pain score 0-10 (0=no pain; 10=worst pain)

Change in Patient-reported Average Pain Between Baseline and 5 Weeks of Treatment With Duloxetine

Pain interference will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory.
Baseline: Mean pain interference for all individual patients in arm 1 (intervention)
5 weeks: Mean pain interference for all individual patients in arm 1 (intervention)
Range of pain interference score 0-10 (0=no interference; 10=worst interference)

Change in Pain Interference Between Baseline and 5 Weeks of Treatment With Duloxetine

Number of sites of pain will be assessed at baseline and 5 weeks for each individual patient using the Michigan Body Map.
Baseline: Mean number of sites of pain for all individual patients in arm 1 (intervention)
5 weeks: Mean number of sites of pain for all individual patients in arm 1 (intervention)
Range of number of sites of pain 0-35 (0=no pain; 35=every pre-defined body site has pain)

Change in Number of Sites of Pain Between Baseline and 5 Weeks of Treatment With Duloxetine

Fibromyalgia Symptom Severity Score will be assessed at baseline and 5 weeks for each individual patient using the Michigan Body Map and Symptom Severity Scale.
Baseline: Mean Fibromyalgia Symptom Severity Score for all individual patients in arm 1 (intervention)
5 weeks: Mean Fibromyalgia Symptom Severity Score for all individual patients in arm 1 (intervention)
Range of Fibromyalgia Symptom Severity Score 0-12 (0=not consistent with fibromyalgia; 12=most consistent with fibromyalgia)

Change in Fibromyalgia Symptom Severity Score Between Baseline and 5 Weeks of Treatment With Duloxetine

PainDETECT score will be assessed at baseline and 5 weeks for each individual patient using the PainDETECT questionnaire.
Baseline: Mean PainDETECT score for all individual patients in arm 1 (intervention)
5 weeks: Mean PainDETECT score for all individual patients in arm 1 (intervention)
Range of PainDETECT score -1-38 (-1=no neuropathic pain; 38=most consistent with neuropathic pain)

Change in PainDETECT Score Between Baseline and 5 Weeks of Treatment With Duloxetine

Neuropathy will be assessed at baseline and 5 weeks for each individual patient using the Functional Assessment of Cancer Therapy-Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) questionnaire.
Baseline: Mean neuropathy score for all individual patients in arm 1 (intervention)
5 weeks: Mean neuropathy score for all individual patients in arm 1 (intervention)
Range of neuropathy score 0-44 (0=no neuropathy; 44=most consistent with neuropathy)

Change in Neuropathy Between Baseline and 5 Weeks of Treatment With Duloxetine

Fatigue will be assessed at baseline and 5 weeks for each individual patient using the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a v1.0 questionnaire. Raw scores are converted to standardized T scores based on national norms for patients with cancer.
Baseline: Mean fatigue T score for all individual patients in arm 1 (intervention)
5 weeks: Mean fatigue T score for all individual patients in arm 1 (intervention)
Average fatigue T score for the reference population of patients with cancer is 50.0, with standard deviation of 10.0 (higher score=more fatigue)

Change in Fatigue Between Baseline and 5 Weeks of Treatment With Duloxetine

Sleep Disturbance will be assessed at baseline and 5 weeks for each individual patient using the PROMIS Sleep Disturbance Short Form 8b v1.0 questionnaire. Raw scores are converted to standardized T scores based on national norms for patients with cancer.
Baseline: Mean sleep disturbance T score for all individual patients in arm 1 (intervention)
5 weeks: Mean sleep disturbance T score for all individual patients in arm 1 (intervention)
Average sleep disturbance T score for the reference population of patients with cancer is 50.0, with standard deviation of 10.0 (higher score=more sleep disturbance)

Change in Sleep Disturbance Between Baseline and 5 Weeks of Treatment With Duloxetine

Physical Function will be assessed at baseline and 5 weeks for each individual patient using the PROMIS Physical Function Short Form 10a v1.0 questionnaire. Raw scores are converted to standardized T scores based on national norms for patients with cancer.
Baseline: Mean physical function T score for all individual patients in arm 1 (intervention)
5 weeks: Mean physical function T score for all individual patients in arm 1 (intervention)
Average physical function T score for the reference population of patients with cancer is 50.0, with standard deviation of 10.0 (higher score=better physical function)

Change in Physical Function Between Baseline and 5 Weeks of Treatment With Duloxetine

Anxiety will be assessed at baseline and 5 weeks for each individual patient using the Hospital Anxiety and Depression Scale.
Baseline: Mean anxiety score for all individual patients in arm 1 (intervention)
5 weeks: Mean anxiety score for all individual patients in arm 1 (intervention)
Range of anxiety score 0-21 (0=no anxiety, 21=maximum anxiety)

Change in Anxiety Between Baseline and 5 Weeks of Treatment With Duloxetine

Depression will be assessed at baseline and 5 weeks for each individual patient using the Hospital Anxiety and Depression Scale.
Baseline: Mean depression score for all individual patients in arm 1 (intervention)
5 weeks: Mean depression score for all individual patients in arm 1 (intervention)
Range of depression score 0-21 (0=no depression, 21=maximum depression)

Change in Depression Between Baseline and 5 Weeks of Treatment With Duloxetine

Cognitive Difficulties - Language will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire.
Baseline: Mean language score for all individual patients in arm 1 (intervention)
5 weeks: Mean language score for all individual patients in arm 1 (intervention)
Range of language score 0-40 (0=no language difficulties, 40=maximum language difficulties)

Change in Cognitive Difficulties - Language Between Baseline and 5 Weeks of Treatment With Duloxetine

Cognitive Difficulties - Visual-Perceptual Ability will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire.
Baseline: Mean visual-perceptual ability score for all individual patients in arm 1 (intervention)
5 weeks: Mean visual-perceptual ability score for all individual patients in arm 1 (intervention)
Range of visual-perceptual ability score 0-30 (0=no visual-perceptual difficulties, 30=maximum visual-perceptual difficulties)

Change in Cognitive Difficulties - Visual-Perceptual Ability Between Baseline and 5 Weeks of Treatment With Duloxetine

Cognitive Difficulties - Verbal Memory will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire.
Baseline: Mean verbal memory score for all individual patients in arm 1 (intervention)
5 weeks: Mean verbal memory score for all individual patients in arm 1 (intervention)
Range of verbal memory score 0-40 (0=no verbal memory difficulties, 40=maximum verbal memory difficulties)

Change in Cognitive Difficulties - Verbal Memory Between Baseline and 5 Weeks of Treatment With Duloxetine

Cognitive Difficulties - Visual-Spatial Memory will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire.
Baseline: Mean visual-spatial memory score for all individual patients in arm 1 (intervention)
5 weeks: Mean visual-spatial memory score for all individual patients in arm 1 (intervention)
Range of visual-spatial memory score 0-40 (0=no visual-spatial memory difficulties, 40=maximum visual-spatial memory difficulties)

Change in Cognitive Difficulties - Visual-Spatial Memory Between Baseline and 5 Weeks of Treatment With Duloxetine

Cognitive Difficulties - Attention/Concentration will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire.
Baseline: Mean attention/concentration score for all individual patients in arm 1 (intervention)
5 weeks: Mean attention/concentration score for all individual patients in arm 1 (intervention)
Range of attention/concentration score 0-40 (0=no attention/concentration difficulties, 40=maximum attention/concentration difficulties)

Change in Cognitive Difficulties - Attention/Concentration Between Baseline and 5 Weeks of Treatment With Duloxetine

Pain sensitivity will be assessed at baseline and 5 weeks for each individual patient using quantitative sensory testing to assess pressure pain threshold (Pain50).
Baseline: Mean Pain50 for all individual patients in arm 1 (intervention) and arm 2 (control)
5 weeks: Mean Pain50 for all individual patients in arm 1 (intervention)
Range of Pain50 score: 0-10 kg/cm2 (higher number reflects higher pain threshold or lower pain sensitivity)

Change in Objectively Assessed Pain Sensitivity Between Baseline and 5 Weeks of Treatment With Duloxetine

Conditioned pain modulation (CPM) will be assessed at baseline and 5 weeks for each individual patient using quantitative sensory testing
Baseline: Mean CPM for all individual patients in arm 1 (intervention) and arm 2 (control)
5 weeks: Mean CPM for all individual patients in arm 1 (intervention)
Range of CPM score: -60 to +60 (more positive values reflect more impaired CPM)

Change in Objectively Assessed Conditioned Pain Modulation Between Baseline and 5 Weeks of Treatment With Duloxetine

Duloxetine 30 mg daily x 1 week, then 60 mg daily x 4 weeks, then 30 mg daily x 2 weeks.
Duloxetine: Subjects will receive 30 mg duloxetine orally for 7 days, then 60 mg duloxetine orally for 28 days, then 30 mg duloxetine orally x 14 days.
Surveys administered at baseline and at 5 weeks.

Because of challenges with logistics of the protocol and pain testing, the trial was redesigned after only 7 patients with pain were enrolled. Three of the patients had been assigned to placebo arm. This arm is not included in any analysis.

Arm 3 - Placebo (Withdrawn)

Overall Study

Lynn Henry, MD, PhD

Pain

Subjects will receive 30 mg duloxetine orally for 7 days, then 60 mg duloxetine orally for 28 days, then 30 mg duloxetine orally x 14 days.

Duloxetine

University of Michigan Rogel Cancer Center

Huntsman Cancer Institute

Mechanistic Study of Duloxetine in Breast Cancer Patients With Chronic Pain

A Study to Identify Predictors of Response to Duloxetine in Breast Cancer Patients With Chronic Pain

American Cancer Society, Inc.

Trial was initially a randomized cross-over design. Soon after study initiation the trial design was amended because of poor accrual, and instead was a single arm open label trial in which all patients with pain were treated with study drug. Since so few patients had been enrolled at the time of study redesign, the only data analyzed were from the single treatment arm portion of the trial, and the non-intervention (baseline only) comparator.

low back pain/cancro da mama

Pain, Nutrition and Glycemic Response in Chronic Low Back Pain and Breast Cancer Survivors

Acupuncture to Reduce Chemotherapy-induced Peripheral Neuropathy Severity During Neoadjuvant or Adjuvant Weekly Paclitaxel Chemotherapy in Breast Cancer Patients

Mechanistic Study of Duloxetine in Breast Cancer Patients With Chronic Pain

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