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

NCT04459104 | Completed

• 1 other identifier: B1432020000025
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 2

Brief Summary

The development of chronic pain is one of the most seen sequelae in the cancer survivor population. Literature reports the presence of pain in approximately 40% of 5-year survivors. Specifically, in breast cancer survivors, chronic pain is estimated to be present in at least 50% of this population. On the other hand, chronic low back pain is one of the leading causes of disability and decrease in quality of life. It has huge economical, psychological and social impacts on individuals, society and health institutions. Unhealthy dietary behavior is associated with the occurrence, maintenance and management of chronic pain. Also, excessive calorie intake and diets rich in sugar, fat, sodium and caffeine were observed in patients having chronic pain. However, although nutritional factors are suggested as an associated lifestyle factor of chronic pain, limited attention is given to dietary and nutritional factors in relation to chronic pain. One particular mechanism drawing attention in the link between nutrition and pain are blood glucose levels and the glycemic response. Animal research shows the potential for reduced blood glucose to influence several pathways involved in chronic pain, including decreased oxidative stress, and reduced neuronal excitability. Given the link between blood glucose levels, as well as the evidence for the importance of interpersonal variability in the glycemic response, this glycemic response can also be of interest for chronic pain research. Finding a possible link between both the glycemic response and pain-related outcomes, could give direction to further research focussing on implementing (personalized) nutritional/dietary advise to maintain healthy blood glucose levels in people suffering from chronic pain. Therefore, this study will provide the first step in this promising line of research, by being the first to look for differences in glycemic response between breast cancer survivors having chronic pain and healthy pain-free controls, and between chronic low back pain patients and healthy pain-free controls. Secondly, this study will also investigate possible associations between glycemic response, pain-related outcomes, nutrition related outcomes, physical activity, and body composition for breast cancer survivors and chronic low back pain patients separately in comparison with healthy pain-free controls.

Conditions

Chronic Pain

Keywords

breast cancer survivors; chronic low back pain; nutrition; diet; glycemic response; fasting glucose level; chronic pain

Outcome Measures

Primary Outcomes (2)

• Glycemic response

  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.

  at the 1st day

• Glycemic response

  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.

  at the 2nd day

Secondary Outcomes (19)

• Brief Pain Inventory

  at the 1st day

• Central Sensitization Inventory

  at the 1st day

• Douleur Neuropathique 4 Questionnaire

  at the 1st day

• Electrical Detection Threshold

  at the 1st day

• Electrical PainThreshold

  at the 1st day

Study Arms (3)

chronic low back patients

EXPERIMENTAL

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

Other: Low glycemic load; Other: High glycemic load

breast cancer survivors having chronic pain

EXPERIMENTAL

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

Other: Low glycemic load; Other: High glycemic load

healthy pain-free controls

ACTIVE COMPARATOR

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

Other: Low glycemic load; Other: High glycemic load

Interventions

Low glycemic load OTHER

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.

breast cancer survivors having chronic pain; chronic low back patients; healthy pain-free controls

High glycemic load OTHER

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.

breast cancer survivors having chronic pain; chronic low back patients; healthy pain-free controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women between 18 and 65 years old;
• Native Dutch speaker;
• Experiencing chronic nonspecific low back pain (i.e. pain present for at least 3 months, at least 3 days per week);
• No new medication or new treatments started in the 6 weeks prior to or during study participation;
• Non-specific failed back surgery can be included if the operation was anatomically successful and happened at least 3 years ago;
• No physical exertions over 3 Metabolic Equivalent of Task (MET) in the 3 days before the assessments;
• No analgesics/ caffeine/ alcohol/ nicotine 48 hours prior to the assessments

You may not qualify if:

• People who have any other diagnosed systemic diseases e.g. diabetes mellitus, hypertension, cardiovascular diseases etc;
• Participants who have neuropathic pain according to "Douleur Neuropathique 4 Questionnaire" and the S-LANSS Neuropathic Pain Score;
• Chronic widespread pain diagnosis (like fibromyalgia, chronic fatigue syndrome, whiplash);
• Current pregnancy or pregnant in the past year;
• Specific spinal pathology (e.g., hernia, spinal stenosis, spondylolisthesis, infection, spinal fracture or malignancy)
• GROUP 2= Breast Cancer Survivors
• Female breast cancer survivors with chronic pain (lasting at least 3 months, at least 3 days per week);
• Participants between 18 and 65 years old;
• Native Dutch speaker;
• Active treatment ended at least 3 months ago (i.e. surgery, radiotherapy and chemotherapy; hormone and immune therapy can be going on);
• No analgesics/ caffeine/ alcohol/ nicotine 48 hours prior to the assessments
• People who have any other systemic disease like hypertension, Type II Diabetes etc;
• Current pregnancy or pregnant in the past year;
• Current active cancer process;
• Tube feeding

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• KU Leuven: collaborator

Study Sites (2)

Vrije Universiteit Brussel

Brussels, 1000, Belgium

Location

KU Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: July 7, 2020
• Study Start: September 21, 2020
• Primary Completion: December 19, 2022
• Study Completion: December 19, 2022
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)