Clinical trial · Interventional
Effect of Hemp-CBD on Patients With CIPN
Coala-T-CBD Study: A Study of the Effect of Hemp-CBD on the Severity and Duration of Chemotherapy-Induced Peripheral Neuropathy in Patients Receiving Neurotoxic Chemotherapy for Non-Metastatic Breast, Uterine, Pancreatic, and Colorectal Cancer and All Stages of Ovarian Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy-induced Peripheral Neuropathy | — | UNRESOLVED | — |
| Colorectal Cancer Stage II | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Cancer Stage III | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Uterine Cancer | Malignant Uterine Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hemp-based CBD | Drug | — | UNRESOLVED |
| Placebo oral tablet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hemp-based CBD
- interventionNames
- Drug: Hemp-based CBD
- type
- PLACEBO_COMPARATOR
- label
- Placebo Oral Tablet
- interventionNames
- Other: Placebo oral tablet
Primary outcomes (7)
- measure
- Change in pressure/touch sensation during intervention and at follow-up
- timeFrame
- Every two weeks for twelve weeks during intervention; One month follow-up
- description
- At regular intervals, CIPN will be assessed by Semmes Weinstein Monofilament Examination using Touch-Test Sensory Evaluator Kit to determine pressure sensation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * Patients taking certain medications will be excluded due to potential CBD-drug interaction. CBD may prevent appropriate drug metabolism increasing risk for toxicity. Co-administration of study product and the following medications will be contraindicated and may lead to participant exclusion: clarithromycin, itraconazole, erythromycin, fluconazole, clopidogrel, rifampin, sulfamethoxazole, warfarin, any opioids, warfarin, antiepileptic medications (including carbamazapine, phenytoin, valproic acid, but excepting of gabapentin, clonazepam or diazepam). * 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)
References
Publications (6)
- BACKGROUNDLee 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
- BACKGROUNDBrzezinski 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
- BACKGROUNDBrzezinski 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
- BACKGROUNDSaif MW, Reardon J. Management of oxaliplatin-induced peripheral neuropathy. Ther Clin Risk Manag. 2005 Dec;1(4):249-58. PMID 18360567
- BACKGROUNDWang 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
- BACKGROUNDWard 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