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NCT04398446: Coala-T-CBD
Effect of Hemp-CBD on Patients With CIPN
Phase 2 trial testing Hemp-based CBD in Chemotherapy-induced Peripheral Neuropathy in 56 participants. Status unknown.
30 November 2022
Quick facts
| Lead sponsor | Main Line Health |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 56 |
| Start date | 27 May 2020 |
| Primary completion | 30 November 2022 |
| Estimated completion | 1 April 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Hemp-based CBD — full drug profile →
- Placebo oral tablet — full drug profile →
Conditions studied
- Chemotherapy-induced Peripheral Neuropathy — all drugs for Chemotherapy-induced Peripheral Neuropathy →
- Colorectal Cancer Stage II — all drugs for Colorectal Cancer Stage II →
- Colorectal Cancer Stage III — all drugs for Colorectal Cancer Stage III →
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Main Line Health — full company profile →
Who can join
21 and older, any sex, with Chemotherapy-induced Peripheral Neuropathy or Colorectal Cancer Stage II. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Cannabinoids in the landscape of cancer.
Mangal N, Erridge S, Habib N, Sadanandam A, et al · · 2021 · cited 72× · PMID 34259916 · DOI 10.1007/s00432-021-03710-7 -
Emerging Pharmacological and Non-Pharmacological Therapeutics for Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy.
Li Y, Lustberg MB, Hu S. · · 2021 · cited 36× · PMID 33673136 · DOI 10.3390/cancers13040766 -
Breast cancer tumor microenvironment affects Treg/IL-17-producing Treg/Th17 cell axis: Molecular and therapeutic perspectives.
Seif F, Torki Z, Zalpoor H, Habibi M, et al · · 2023 · cited 31× · PMID 36816749 · DOI 10.1016/j.omto.2023.01.001 -
Cannabis, Cannabinoids and Cannabis-Based Medicines in Cancer Care.
Abrams DI. · · 2022 · cited 25× · PMID 35225051 · DOI 10.1177/15347354221081772 -
Phytocannabinoids, the Endocannabinoid System and Male Reproduction.
Lim J, Squire E, Jung KM. · · 2023 · cited 13× · PMID 36578200 · DOI 10.5534/wjmh.220132 -
Cannabinoids: an Effective Treatment for Chemotherapy-Induced Peripheral Neurotoxicity?
Cavaletti G, Marmiroli P, Renn CL, Dorsey SG, et al · · 2021 · cited 13× · PMID 34668147 · DOI 10.1007/s13311-021-01127-1 -
Integrated Medicine for Chemotherapy-Induced Peripheral Neuropathy.
Tsai CH, Lin YH, Li YS, Ho TL, et al · · 2021 · cited 12× · PMID 34502166 · DOI 10.3390/ijms22179257 -
Combination CBD/THC in the management of chemotherapy-induced peripheral neuropathy: a randomized double blind controlled trial.
Weiss M, Giaddui M, Kjelstrom S, Gary J, et al · · 2025 · PMID 41211445 · DOI 10.3389/fonc.2025.1590168
Verify or expand the search:
- PubMed search for NCT04398446
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Chemotherapy-induced Peripheral Neuropathy
Currently open trials in the same condition.
- NCT07177820 — VGAIT for Chemotherapy-induced Peripheral Neuropathy · NA · recruiting
- NCT07072468 — Analgesic Efficacy and Safety of Topical VMD-3866 Gel in Management of Pain Induced by Chemotherapy (CIPN) · Phase 2 · recruiting
- NCT06389721 — Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy · recruiting
- NCT06405542 — Exercise-based Rehabilitation to Treat Persistent Chemotherapy Induced Peripheral Neuropathy (CIPN) · Phase 1 · active not recruiting
- NCT06162403 — Exploring the Benefit of Peripheral Nerve Stimulation in Treating Pain From Chemo-induced Peripheral Neuropathy: A Longi · NA · recruiting
Other Main Line Health trials
Trials by the same sponsor.
- NCT06439524 — The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial · Phase 3 · recruiting
- NCT05541679 — Comparison of Left Bundle Branch Area Versus Right Ventricular Septal Pacing in Patients With High-degree Conduction Dis · NA · active not recruiting
- NCT04086394 — PECS Block in Partial Mastectomy for Postoperative Pain Control · NA · unknown
- NCT04290208 — A Comparison of IV Versus PO Acetaminophen Postoperatively for Opioid Consumption After Cesarean Section · Phase 4 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04398446 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Main Line Health
- Last refreshed: 1 September 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04398446.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing