Effect of Hemp-CBD on Patients With CIPN

NCT04398446 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: F/N-R19-3893L
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effect of a hemp-based cannabidiol (CBD) product, Ananda Hemp Spectrum Gelcaps, on the severity and duration of chemotherapy-induced neuropathy (CIPN) among non-metastatic breast, uterine, pancreatic, and colorectal cancer, and all stages of ovarian cancer in patients who received neoadjuvant or adjuvant therapy that included neurotoxic chemotherapeutic agents.

Conditions

Chemotherapy-induced Peripheral Neuropathy; Colorectal Cancer Stage II; Colorectal Cancer Stage III; Breast Cancer; Ovarian Cancer; Uterine Cancer; Pancreatic Cancer

Outcome Measures

Primary Outcomes (7)

• Change in pressure/touch sensation during intervention and at follow-up

  At regular intervals, CIPN will be assessed by Semmes Weinstein Monofilament Examination using Touch-Test Sensory Evaluator Kit to determine pressure sensation.

  Every two weeks for twelve weeks during intervention; One month follow-up

• Change in pain sensation during intervention and at follow-up

  At regular intervals, CIPN will be assessed by pinprick examination to determine pain sensation.

  Every two weeks for twelve weeks during intervention; One month follow-up

• Change in vibration sensation during intervention and at follow-up

  At regular intervals, CIPN will be assessed by 128Hz tuning fork vibration test to determine vibration sensation.

  Every two weeks for twelve weeks during intervention; One month follow-up

• Change in quality of life

  Quality of life will be measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire, a validated 30-item questionnaire to assess treatment impact on quality of life in cancer patients on 4-point scales, where 4 is most severe.

  Every two weeks for twelve weeks during intervention; One month follow-up

• Change in CIPN symptom severity

  CIPN symptoms will be measured by EORTC QLQ-CIPN20 Questionnaire, validated 20-item questionnaire to assess symptom severity of chemotherapy-induced peripheral neuropathy on 4-point scales, where 4 is most severe.

  Every two weeks for twelve weeks during intervention; One month follow-up

• Change in pain severity

  Pain severity will be measured by Brief Pain Inventory (BPI) Short Form, validated 9-item questionnaire to assess the severity of pain and the impact of pain on daily functions on 10-point scales, where 10 is most severe.

  Every two weeks for twelve weeks during intervention; One month follow-up

• Change in sleep quality

  Sleep quality will be measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Questionnaire, validated 8-item questionnaire to assess sleep quality on 5-point scales, where 5 is the most severe.

  Every two weeks for twelve weeks during intervention; One month follow-up

Secondary Outcomes (3)

• Receptivity and accrual rate to clinical studies involving cannabis-based substances.

  1 Day

• Adherence to CBD Products

  Daily, 12 weeks

• Rate of side effects using medical-grade CBD concentrates

  Daily, 12 weeks

Study Arms (2)

Hemp-based CBD

EXPERIMENTAL

Drug: Hemp-based CBD

Placebo Oral Tablet

PLACEBO COMPARATOR

Other: Placebo oral tablet

Interventions

Hemp-based CBD DRUG

3x Daily dosing for 12 weeks

Also known as: Ananda Hemp CBD Spectrum Gelcaps

Hemp-based CBD

Placebo oral tablet OTHER

3x Daily dosing for 12 weeks

Placebo Oral Tablet

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-metastatic breast cancer patients who developed CIPN (CTCAE sensory grade 2 or 3, motor grade \<2) after receiving taxane-based chemotherapy in pre-operative or post-operative setting.
• Non-metastatic Colorectal cancer patients with high risk stage II and stage III disease who developed CIPN (CTCAE sensory grade 2 or 3, motor grade \<2) after receiving oxaliplatin in the adjuvant setting.
• Ovarian cancer patients who developed CIPN (CTCAE sensory grade 2 or 3, motor grade \<2) after receiving taxane-containing chemotherapy in the neoadjuvant or adjuvant setting .
• Uterine cancer patients who developed CIPN (CTCAE grade 2 or 3) after receiving taxane-containing chemotherapy in the neoadjuvant or adjuvant setting.
• Non-metastatic pancreatic cancer patients who developed CIPN (CTCAE grade 2 or 3) after receiving taxane-containing chemotherapy in the neoadjuvant or adjuvant setting.

You may not qualify if:

• Family history of genetic/familial neuropathy
• Routine use of recreational or medicinal marijuana products (defined as \> 4 times per month) or illicit drug use (positive urine drug screen including opioids, cocaine, amphetamines, PCP, LSD)
• Known underlying liver disease (Child-Pugh B or C) or baseline elevation in ALT, AST or total bilirubin ≥1.5 x upper limit of normal
• Underlying history of epilepsy/ recurrent seizure disorder or unexplained seizure within past 6 months
• Patients with uncontrolled cardiovascular disease defined by myocardial infarction, stroke or transient ischemic attack, or need for coronary stent placement within past six months.
• Patients with uncontrolled psychiatric illness (who meet DSM-V criteria) or who are at increased risk for suicidality based on baseline Columbia-Suicide Severity Rating Scale.
• Women who are pregnant or breastfeeding or who refuse to practice an effective form of birth control (condoms, diaphragm, birth control pill, IUD)

Sponsors & Collaborators

• Main Line Health: lead
• Ananda Hemp, Inc.: collaborator

Study Sites (1)

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

Related Publications (6)

• Lee G, Grovey B, Furnish T, Wallace M. Medical Cannabis for Neuropathic Pain. Curr Pain Headache Rep. 2018 Feb 1;22(1):8. doi: 10.1007/s11916-018-0658-8.

  PMID: 29388063 BACKGROUND

• Brzezinski K. Chemotherapy-induced polyneuropathy. Part I. Pathophysiology. Contemp Oncol (Pozn). 2012;16(1):72-8. doi: 10.5114/wo.2012.27341. Epub 2012 Feb 29.

  PMID: 23788859 BACKGROUND

• Brzezinski K. Chemotherapy-induced peripheral neuropathy. Part II. Prevention. Contemp Oncol (Pozn). 2012;16(3):258-61. doi: 10.5114/wo.2012.29296. Epub 2012 Jul 6.

  PMID: 23788891 BACKGROUND

• Saif MW, Reardon J. Management of oxaliplatin-induced peripheral neuropathy. Ther Clin Risk Manag. 2005 Dec;1(4):249-58.

  PMID: 18360567 BACKGROUND

• Wang WS, Lin JK, Lin TC, Chen WS, Jiang JK, Wang HS, Chiou TJ, Liu JH, Yen CC, Chen PM. Oral glutamine is effective for preventing oxaliplatin-induced neuropathy in colorectal cancer patients. Oncologist. 2007 Mar;12(3):312-9. doi: 10.1634/theoncologist.12-3-312.

  PMID: 17405895 BACKGROUND

• Ward SJ, Ramirez MD, Neelakantan H, Walker EA. Cannabidiol prevents the development of cold and mechanical allodynia in paclitaxel-treated female C57Bl6 mice. Anesth Analg. 2011 Oct;113(4):947-50. doi: 10.1213/ANE.0b013e3182283486. Epub 2011 Jul 7.

  PMID: 21737705 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Uterine Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Diseases; Pancreatic Diseases

Study Officials

• Marisa Weiss, MD

  Main Line Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Breast Radiation Oncology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: May 21, 2020
• Study Start: May 27, 2020
• Primary Completion: November 30, 2022
• Study Completion: April 1, 2023
• Last Updated: September 1, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)